Trial Outcomes & Findings for The P4 Intervention Study to Improve Adolescent Health (NCT NCT02554682)

NCT ID: NCT02554682

Last Updated: 2019-04-10

Results Overview

Parents completed the 20-item Parent-Adolescent Communication Scale (PACS) (Barnes \& Olson, 1985) which is scored such that a higher total score (sum of all items across scales) indicated better parent-adolescent communication. Teens answered the same questions, with only minor changes in wording when necessary. Scores were summed into an index that ranged from 41-96, α parent = 0.84, and 43-96, α teen = 0.87.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

348 participants

Primary outcome timeframe

4-6 months post-enrollment

Results posted on

2019-04-10

Participant Flow

Adolescents between 14 and 17 years of age with an upcoming well-child visit and a parent were recruited from January 2016 through September 2016 from one urban primary care practice in the Pediatrics Research Consortium (PeRC) at Children's Hospital of Philadelphia (CHOP).

A total of 425 parent-adolescent dyads were contacted and screened. Of these, 188 (44%) did not meet eligibility criteria, 26 (6%) declined, and 37 (9%) could not be scheduled or reached again. 174 participant dyads we randomized into one of the five assignment groups.

Participant milestones

Participant milestones
Measure
Sexual Health (Teen)
Teens between the ages of 14 and 15 will review psychoeducational workbooks related to sexual health at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials. Sexual Health: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about sexual health, sexually transmitted disease (STD) prevention, and safe sex practices for teenager.
Sexual Health (Parent)
Parents of teens between the ages of 14 and 15 will review psychoeducational workbooks related to sexual health at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials. Sexual Health: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about sexual health, sexually transmitted disease (STD) prevention, and safe sex practices for teenager.
Alcohol Prevention (Teen)
Teens between the ages of 14 and 15 will review psychoeducational workbooks related to alcohol prevention at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials. Alcohol Prevention: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about alcohol prevention and safety, underage drinking, and drinking and driving.
Alcohol Prevention (Parent)
Parents of teens between the ages of 14 and 15 will review psychoeducational workbooks related to alcohol prevention at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials. Alcohol Prevention: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about alcohol prevention and safety, underage drinking, and drinking and driving.
Sexual Health & Alcohol Control Group (Teen)
Teens between the ages of 14 and 15 will receive their usual care at their well-child visit appointment with their primary care giver (baseline) and then at 4 to 5 months post baseline we will collect data. At the end of the post data collection, the control group will get all of the study materials from both the sexual health and alcohol prevention groups.
Sexual Health & Alcohol Group (Parent)
Parents of teens between the ages of 14 and 15 will receive their usual care at their well-child visit appointment with their primary care giver (baseline) and then at 4 to 5 months post baseline we will collect data. At the end of the post data collection, the control group will get all of the study materials from both the sexual health and alcohol prevention groups.
Teen Driving (Teen)
Teens between the ages of 16 and 17 who are planning on having the medical certification for the permit application completed and plan on taking their driving permit test in the next 8 weeks will review psychoeducational workbooks related to teen driving at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 6 months post baseline we will collect data to assess the effectiveness of the study materials. Teen Driving: Psychoeducational workbook, worksheets, videos, tip sheets, and health coaching session about how parents can help supervise their teens' safe driving practices and how to talk with their teen about important safety topics for teen drivers.
Teen Driving (Parent)
Parents of teens between the ages of 16 and 17 who are planning on having the medical certification for the permit application completed and plan on taking their driving permit test in the next 8 weeks will review psychoeducational workbooks related to teen driving at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 6 months post baseline we will collect data to assess the effectiveness of the study materials. Teen Driving: Psychoeducational workbook, worksheets, videos, tip sheets, and health coaching session about how parents can help supervise their teens' safe driving practices and how to talk with their teen about important safety topics for teen drivers.
Teen Driving Control (Teen)
Parents of teens between the ages of 16 and 17 who are planning on having the medical certification for the permit application completed and plan on taking their driving permit test in the next 8 weeks will receive their usual care at their well-child visit appointment with their primary care giver (baseline) and then at 6 months post baseline we will collect data. At the end of the post data collection, the control group will get all of the study materials from the teen driving group.
Teen Driving Control (Parent)
Teens between the ages of 16 and 17 who are planning on having the medical certification for the permit application completed and plan on taking their driving permit test in the next 8 weeks will receive their usual care at their well-child visit appointment with their primary care giver (baseline) and then at 6 months post baseline we will collect data. At the end of the post data collection, the control group will get all of the study materials from the teen driving group.
Overall Study
STARTED
40
40
40
40
40
40
28
28
26
26
Overall Study
COMPLETED
25
28
36
37
38
39
22
22
24
24
Overall Study
NOT COMPLETED
15
12
4
3
2
1
6
6
2
2

Reasons for withdrawal

Reasons for withdrawal
Measure
Sexual Health (Teen)
Teens between the ages of 14 and 15 will review psychoeducational workbooks related to sexual health at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials. Sexual Health: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about sexual health, sexually transmitted disease (STD) prevention, and safe sex practices for teenager.
Sexual Health (Parent)
Parents of teens between the ages of 14 and 15 will review psychoeducational workbooks related to sexual health at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials. Sexual Health: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about sexual health, sexually transmitted disease (STD) prevention, and safe sex practices for teenager.
Alcohol Prevention (Teen)
Teens between the ages of 14 and 15 will review psychoeducational workbooks related to alcohol prevention at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials. Alcohol Prevention: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about alcohol prevention and safety, underage drinking, and drinking and driving.
Alcohol Prevention (Parent)
Parents of teens between the ages of 14 and 15 will review psychoeducational workbooks related to alcohol prevention at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials. Alcohol Prevention: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about alcohol prevention and safety, underage drinking, and drinking and driving.
Sexual Health & Alcohol Control Group (Teen)
Teens between the ages of 14 and 15 will receive their usual care at their well-child visit appointment with their primary care giver (baseline) and then at 4 to 5 months post baseline we will collect data. At the end of the post data collection, the control group will get all of the study materials from both the sexual health and alcohol prevention groups.
Sexual Health & Alcohol Group (Parent)
Parents of teens between the ages of 14 and 15 will receive their usual care at their well-child visit appointment with their primary care giver (baseline) and then at 4 to 5 months post baseline we will collect data. At the end of the post data collection, the control group will get all of the study materials from both the sexual health and alcohol prevention groups.
Teen Driving (Teen)
Teens between the ages of 16 and 17 who are planning on having the medical certification for the permit application completed and plan on taking their driving permit test in the next 8 weeks will review psychoeducational workbooks related to teen driving at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 6 months post baseline we will collect data to assess the effectiveness of the study materials. Teen Driving: Psychoeducational workbook, worksheets, videos, tip sheets, and health coaching session about how parents can help supervise their teens' safe driving practices and how to talk with their teen about important safety topics for teen drivers.
Teen Driving (Parent)
Parents of teens between the ages of 16 and 17 who are planning on having the medical certification for the permit application completed and plan on taking their driving permit test in the next 8 weeks will review psychoeducational workbooks related to teen driving at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 6 months post baseline we will collect data to assess the effectiveness of the study materials. Teen Driving: Psychoeducational workbook, worksheets, videos, tip sheets, and health coaching session about how parents can help supervise their teens' safe driving practices and how to talk with their teen about important safety topics for teen drivers.
Teen Driving Control (Teen)
Parents of teens between the ages of 16 and 17 who are planning on having the medical certification for the permit application completed and plan on taking their driving permit test in the next 8 weeks will receive their usual care at their well-child visit appointment with their primary care giver (baseline) and then at 6 months post baseline we will collect data. At the end of the post data collection, the control group will get all of the study materials from the teen driving group.
Teen Driving Control (Parent)
Teens between the ages of 16 and 17 who are planning on having the medical certification for the permit application completed and plan on taking their driving permit test in the next 8 weeks will receive their usual care at their well-child visit appointment with their primary care giver (baseline) and then at 6 months post baseline we will collect data. At the end of the post data collection, the control group will get all of the study materials from the teen driving group.
Overall Study
Lost to Follow-up
11
9
4
3
2
1
6
6
2
2
Overall Study
Withdrawal by Subject
2
1
0
0
0
0
0
0
0
0
Overall Study
Physician Decision
2
2
0
0
0
0
0
0
0
0

Baseline Characteristics

The P4 Intervention Study to Improve Adolescent Health

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Sexual Health (Teen)
n=38 Participants
Teens between the ages of 14 and 15 will review psychoeducational workbooks related to sexual health at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials. Sexual Health: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about sexual health, sexually transmitted disease (STD) prevention, and safe sex practices for teenager.
Sexual Health (Parent)
n=38 Participants
Parents of teens between the ages of 14 and 15 will review psychoeducational workbooks related to sexual health at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials. Sexual Health: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about sexual health, sexually transmitted disease (STD) prevention, and safe sex practices for teenager.
Alcohol Prevention (Teen)
n=40 Participants
Teens between the ages of 14 and 15 will review psychoeducational workbooks related to alcohol prevention at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials. Alcohol Prevention: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about alcohol prevention and safety, underage drinking, and drinking and driving.
Alcohol Prevention (Parent)
n=40 Participants
Parents of teens between the ages of 14 and 15 will review psychoeducational workbooks related to alcohol prevention at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials. Alcohol Prevention: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about alcohol prevention and safety, underage drinking, and drinking and driving.
Sexual Health & Alcohol Control Group (Teen)
n=40 Participants
Teens between the ages of 14 and 15 will receive their usual care at their well-child visit appointment with their primary care giver (baseline) and then at 4 to 5 months post baseline we will collect data. At the end of the post data collection, the control group will get all of the study materials from both the sexual health and alcohol prevention groups.
Sexual Health & Alcohol Control Group (Parent)
n=40 Participants
Parents of teens between the ages of 14 and 15 will receive their usual care at their well-child visit appointment with their primary care giver (baseline) and then at 4 to 5 months post baseline we will collect data. At the end of the post data collection, the control group will get all of the study materials from both the sexual health and alcohol prevention groups.
Teen Driving (Teen)
n=28 Participants
Teens between the ages of 16 and 17 who are planning on having the medical certification for the permit application completed and plan on taking their driving permit test in the next 8 weeks will review psychoeducational workbooks related to teen driving at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 6 months post baseline we will collect data to assess the effectiveness of the study materials. Teen Driving: Psychoeducational workbook, worksheets, videos, tip sheets, and health coaching session about how parents can help supervise their teens' safe driving practices and how to talk with their teen about important safety topics for teen drivers.
Teen Driving (Parent)
n=28 Participants
Parents of teens between the ages of 16 and 17 who are planning on having the medical certification for the permit application completed and plan on taking their driving permit test in the next 8 weeks will review psychoeducational workbooks related to teen driving at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 6 months post baseline we will collect data to assess the effectiveness of the study materials. Teen Driving: Psychoeducational workbook, worksheets, videos, tip sheets, and health coaching session about how parents can help supervise their teens' safe driving practices and how to talk with their teen about important safety topics for teen drivers.
Teen Driving Control (Teens)
n=26 Participants
Teens between the ages of 16 and 17 who are planning on having the medical certification for the permit application completed and plan on taking their driving permit test in the next 8 weeks will receive their usual care at their well-child visit appointment with their primary care giver (baseline) and then at 6 months post baseline we will collect data. At the end of the post data collection, the control group will get all of the study materials from the teen driving group.
Teen Driving Control (Parent)
n=26 Participants
Parents of teens between the ages of 16 and 17 who are planning on having the medical certification for the permit application completed and plan on taking their driving permit test in the next 8 weeks will receive their usual care at their well-child visit appointment with their primary care giver (baseline) and then at 6 months post baseline we will collect data. At the end of the post data collection, the control group will get all of the study materials from the teen driving group.
Total
n=344 Participants
Total of all reporting groups
Age, Categorical
<=18 years
38 Participants
n=99 Participants
0 Participants
n=107 Participants
40 Participants
n=206 Participants
0 Participants
n=7 Participants
40 Participants
n=31 Participants
0 Participants
n=30 Participants
28 Participants
n=3 Participants
0 Participants
n=6 Participants
26 Participants
n=114 Participants
0 Participants
172 Participants
n=19 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
n=99 Participants
37 Participants
n=107 Participants
0 Participants
n=206 Participants
40 Participants
n=7 Participants
0 Participants
n=31 Participants
40 Participants
n=30 Participants
0 Participants
n=3 Participants
28 Participants
n=6 Participants
0 Participants
n=114 Participants
25 Participants
170 Participants
n=19 Participants
Age, Categorical
>=65 years
0 Participants
n=99 Participants
1 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
0 Participants
n=31 Participants
0 Participants
n=30 Participants
0 Participants
n=3 Participants
0 Participants
n=6 Participants
0 Participants
n=114 Participants
1 Participants
2 Participants
n=19 Participants
Age, Continuous
14.71 years
STANDARD_DEVIATION .53 • n=99 Participants
45.13 years
STANDARD_DEVIATION 8.6 • n=107 Participants
14.83 years
STANDARD_DEVIATION .53 • n=206 Participants
45.20 years
STANDARD_DEVIATION 5.8 • n=7 Participants
15.05 years
STANDARD_DEVIATION .58 • n=31 Participants
47.05 years
STANDARD_DEVIATION 5.9 • n=30 Participants
16.81 years
STANDARD_DEVIATION .56 • n=3 Participants
46.57 years
STANDARD_DEVIATION 7.88 • n=6 Participants
16.40 years
STANDARD_DEVIATION .40 • n=114 Participants
49.58 years
STANDARD_DEVIATION 8.50
31.13 years
STANDARD_DEVIATION 16.47 • n=19 Participants
Sex: Female, Male
Female
18 Participants
n=99 Participants
35 Participants
n=107 Participants
21 Participants
n=206 Participants
39 Participants
n=7 Participants
21 Participants
n=31 Participants
38 Participants
n=30 Participants
14 Participants
n=3 Participants
28 Participants
n=6 Participants
13 Participants
n=114 Participants
23 Participants
250 Participants
n=19 Participants
Sex: Female, Male
Male
20 Participants
n=99 Participants
3 Participants
n=107 Participants
19 Participants
n=206 Participants
1 Participants
n=7 Participants
19 Participants
n=31 Participants
2 Participants
n=30 Participants
14 Participants
n=3 Participants
0 Participants
n=6 Participants
13 Participants
n=114 Participants
3 Participants
94 Participants
n=19 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=99 Participants
0 Participants
n=107 Participants
2 Participants
n=206 Participants
0 Participants
n=7 Participants
1 Participants
n=31 Participants
0 Participants
n=30 Participants
0 Participants
n=3 Participants
0 Participants
n=6 Participants
0 Participants
n=114 Participants
0 Participants
3 Participants
n=19 Participants
Race (NIH/OMB)
Asian
1 Participants
n=99 Participants
0 Participants
n=107 Participants
1 Participants
n=206 Participants
0 Participants
n=7 Participants
1 Participants
n=31 Participants
1 Participants
n=30 Participants
0 Participants
n=3 Participants
0 Participants
n=6 Participants
0 Participants
n=114 Participants
1 Participants
5 Participants
n=19 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
0 Participants
n=31 Participants
0 Participants
n=30 Participants
0 Participants
n=3 Participants
0 Participants
n=6 Participants
0 Participants
n=114 Participants
0 Participants
0 Participants
n=19 Participants
Race (NIH/OMB)
Black or African American
19 Participants
n=99 Participants
20 Participants
n=107 Participants
22 Participants
n=206 Participants
22 Participants
n=7 Participants
19 Participants
n=31 Participants
20 Participants
n=30 Participants
24 Participants
n=3 Participants
19 Participants
n=6 Participants
18 Participants
n=114 Participants
17 Participants
200 Participants
n=19 Participants
Race (NIH/OMB)
White
16 Participants
n=99 Participants
17 Participants
n=107 Participants
13 Participants
n=206 Participants
15 Participants
n=7 Participants
18 Participants
n=31 Participants
18 Participants
n=30 Participants
4 Participants
n=3 Participants
4 Participants
n=6 Participants
7 Participants
n=114 Participants
6 Participants
118 Participants
n=19 Participants
Race (NIH/OMB)
More than one race
2 Participants
n=99 Participants
1 Participants
n=107 Participants
2 Participants
n=206 Participants
3 Participants
n=7 Participants
1 Participants
n=31 Participants
1 Participants
n=30 Participants
0 Participants
n=3 Participants
4 Participants
n=6 Participants
1 Participants
n=114 Participants
2 Participants
17 Participants
n=19 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
0 Participants
n=31 Participants
0 Participants
n=30 Participants
0 Participants
n=3 Participants
1 Participants
n=6 Participants
0 Participants
n=114 Participants
0 Participants
1 Participants
n=19 Participants
Region of Enrollment
United States
38 Participants
n=99 Participants
38 Participants
n=107 Participants
40 Participants
n=206 Participants
40 Participants
n=7 Participants
40 Participants
n=31 Participants
40 Participants
n=30 Participants
28 Participants
n=3 Participants
28 Participants
n=6 Participants
26 Participants
n=114 Participants
26 Participants
344 Participants
n=19 Participants

PRIMARY outcome

Timeframe: 4-6 months post-enrollment

Population: Arm 1 only. Parents and teens analyzed separately. Arm 2 (teen driving) had different primary outcomes (see outcomes 4-15) and therefore was not included here.

Parents completed the 20-item Parent-Adolescent Communication Scale (PACS) (Barnes \& Olson, 1985) which is scored such that a higher total score (sum of all items across scales) indicated better parent-adolescent communication. Teens answered the same questions, with only minor changes in wording when necessary. Scores were summed into an index that ranged from 41-96, α parent = 0.84, and 43-96, α teen = 0.87.

Outcome measures

Outcome measures
Measure
Sexual Health (Parent)
n=28 Participants
Parents of teens between the ages of 14 and 15 will review psychoeducational workbooks related to sexual health at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials. Sexual Health: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about sexual health, sexually transmitted disease (STD) prevention, and safe sex practices for teenager.
Sexual Health (Teen)
n=25 Participants
Teens between the ages of 14 and 15 will review psychoeducational workbooks related to sexual health at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials. Sexual Health: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about sexual health, sexually transmitted disease (STD) prevention, and safe sex practices for teenager.
Alcohol Prevention (Parent)
n=37 Participants
Parents of teens between the ages of 14 and 15 will review psychoeducational workbooks related to alcohol prevention at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials. Alcohol Prevention: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about alcohol prevention and safety, underage drinking, and drinking and driving.
Alcohol (Teen)
n=36 Participants
Parents of teens between the ages of 14 and 15 will review psychoeducational workbooks related to alcohol prevention at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials. Alcohol Prevention: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about alcohol prevention and safety, underage drinking, and drinking and driving.
Sexual Health & Alcohol Control Group (Parent)
n=39 Participants
Parents of teens between the ages of 14 and 15 will receive their usual care at their well-child visit appointment with their primary care giver (baseline) and then at 4 to 5 months post baseline we will collect data. At the end of the post data collection, the control group will get all of the study materials from both the sexual health and alcohol prevention groups.
Sexual Health and Alcohol Control Group (Teen)
n=38 Participants
Parents of teens between the ages of 14 and 15 will receive their usual care at their well-child visit appointment with their primary care giver (baseline) and then at 4 to 5 months post baseline we will collect data. At the end of the post data collection, the control group will get all of the study materials from both the sexual health and alcohol prevention groups.
Quality of Parent-teen Communication (General- All Groups)
77.8 units on a scale
Standard Deviation 10.5
73.0 units on a scale
Standard Deviation 9.4
77.2 units on a scale
Standard Deviation 8.6
69.1 units on a scale
Standard Deviation 8.4
77.4 units on a scale
Standard Deviation 10.3
68.6 units on a scale
Standard Deviation 11.1

PRIMARY outcome

Timeframe: 4-6 months post-enrollment

Population: Arm 1 only. Parents and teens analyzed separately. Arm 2 (teen driving) had different primary outcomes (see outcomes 4-15) and therefore was not included here.

Frequency of communication about alcohol was measured with a single item followed by 4-point Likert-type response categories. Parents were asked: Since your teen's last well-child visit how much have you talked with your teen about alcohol? (Not at all (1), A little bit (2), Quite a bit (3), or A lot (4)). Teens were asked: Since your last well-child visit, how often have you and your (mother/father) talked about alcohol? (Never (1), Rarely (2), Sometimes (3), or Often (4)).

Outcome measures

Outcome measures
Measure
Sexual Health (Parent)
n=25 Participants
Parents of teens between the ages of 14 and 15 will review psychoeducational workbooks related to sexual health at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials. Sexual Health: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about sexual health, sexually transmitted disease (STD) prevention, and safe sex practices for teenager.
Sexual Health (Teen)
n=28 Participants
Teens between the ages of 14 and 15 will review psychoeducational workbooks related to sexual health at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials. Sexual Health: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about sexual health, sexually transmitted disease (STD) prevention, and safe sex practices for teenager.
Alcohol Prevention (Parent)
n=36 Participants
Parents of teens between the ages of 14 and 15 will review psychoeducational workbooks related to alcohol prevention at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials. Alcohol Prevention: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about alcohol prevention and safety, underage drinking, and drinking and driving.
Alcohol (Teen)
n=37 Participants
Parents of teens between the ages of 14 and 15 will review psychoeducational workbooks related to alcohol prevention at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials. Alcohol Prevention: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about alcohol prevention and safety, underage drinking, and drinking and driving.
Sexual Health & Alcohol Control Group (Parent)
n=38 Participants
Parents of teens between the ages of 14 and 15 will receive their usual care at their well-child visit appointment with their primary care giver (baseline) and then at 4 to 5 months post baseline we will collect data. At the end of the post data collection, the control group will get all of the study materials from both the sexual health and alcohol prevention groups.
Sexual Health and Alcohol Control Group (Teen)
n=39 Participants
Parents of teens between the ages of 14 and 15 will receive their usual care at their well-child visit appointment with their primary care giver (baseline) and then at 4 to 5 months post baseline we will collect data. At the end of the post data collection, the control group will get all of the study materials from both the sexual health and alcohol prevention groups.
Frequency of Communication About Alcohol
2.7 units on a scale
Standard Deviation 1.0
2.5 units on a scale
Standard Deviation 0.8
2.9 units on a scale
Standard Deviation 0.8
2.6 units on a scale
Standard Deviation 0.8
2.4 units on a scale
Standard Deviation 1.2
2.5 units on a scale
Standard Deviation 0.9

PRIMARY outcome

Timeframe: 4-6 months post-enrollment

Population: Arm 1 only. Parents and teens analyzed separately. Arm 2 (teen driving) had different primary outcomes (see outcomes 4-15) and therefore was not included here.

Frequency of communication about sex was measured with a single item followed by 4-point Likert-type response categories. Parents were asked: Since your teen's last well-child visit how much have you talked with your teen about sex? (Not at all (1), A little bit (2), Quite a bit (3), or A lot (4)). Teens were asked: Since your last well-child visit, how often have you and your (mother/father) talked about sex? (Never (1), Rarely (2), Sometimes (3), or Often (4)).

Outcome measures

Outcome measures
Measure
Sexual Health (Parent)
n=25 Participants
Parents of teens between the ages of 14 and 15 will review psychoeducational workbooks related to sexual health at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials. Sexual Health: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about sexual health, sexually transmitted disease (STD) prevention, and safe sex practices for teenager.
Sexual Health (Teen)
n=28 Participants
Teens between the ages of 14 and 15 will review psychoeducational workbooks related to sexual health at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials. Sexual Health: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about sexual health, sexually transmitted disease (STD) prevention, and safe sex practices for teenager.
Alcohol Prevention (Parent)
n=36 Participants
Parents of teens between the ages of 14 and 15 will review psychoeducational workbooks related to alcohol prevention at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials. Alcohol Prevention: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about alcohol prevention and safety, underage drinking, and drinking and driving.
Alcohol (Teen)
n=37 Participants
Parents of teens between the ages of 14 and 15 will review psychoeducational workbooks related to alcohol prevention at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials. Alcohol Prevention: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about alcohol prevention and safety, underage drinking, and drinking and driving.
Sexual Health & Alcohol Control Group (Parent)
n=38 Participants
Parents of teens between the ages of 14 and 15 will receive their usual care at their well-child visit appointment with their primary care giver (baseline) and then at 4 to 5 months post baseline we will collect data. At the end of the post data collection, the control group will get all of the study materials from both the sexual health and alcohol prevention groups.
Sexual Health and Alcohol Control Group (Teen)
n=39 Participants
Parents of teens between the ages of 14 and 15 will receive their usual care at their well-child visit appointment with their primary care giver (baseline) and then at 4 to 5 months post baseline we will collect data. At the end of the post data collection, the control group will get all of the study materials from both the sexual health and alcohol prevention groups.
Frequency of Communication About Sex
2.3 units on a scale
Standard Deviation 0.8
2.8 units on a scale
Standard Deviation 0.8
2.1 units on a scale
Standard Deviation 1.1
2.3 units on a scale
Standard Deviation 0.9
1.8 units on a scale
Standard Deviation 0.8
2.4 units on a scale
Standard Deviation 1.0

PRIMARY outcome

Timeframe: 6 months post-enrollment

Population: Parent Population

Six months after baseline, parents reported on the frequency that they talked about reasons the teen wants to drive. Parents selected from one of the following response choices: "never talked about" (0); "talked about once or twice" (1); "talked about three or four times" (2); "talked about a lot, about 5 times or more" (3).

Outcome measures

Outcome measures
Measure
Sexual Health (Parent)
n=22 Participants
Parents of teens between the ages of 14 and 15 will review psychoeducational workbooks related to sexual health at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials. Sexual Health: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about sexual health, sexually transmitted disease (STD) prevention, and safe sex practices for teenager.
Sexual Health (Teen)
n=24 Participants
Teens between the ages of 14 and 15 will review psychoeducational workbooks related to sexual health at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials. Sexual Health: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about sexual health, sexually transmitted disease (STD) prevention, and safe sex practices for teenager.
Alcohol Prevention (Parent)
Parents of teens between the ages of 14 and 15 will review psychoeducational workbooks related to alcohol prevention at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials. Alcohol Prevention: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about alcohol prevention and safety, underage drinking, and drinking and driving.
Alcohol (Teen)
Parents of teens between the ages of 14 and 15 will review psychoeducational workbooks related to alcohol prevention at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials. Alcohol Prevention: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about alcohol prevention and safety, underage drinking, and drinking and driving.
Sexual Health & Alcohol Control Group (Parent)
Parents of teens between the ages of 14 and 15 will receive their usual care at their well-child visit appointment with their primary care giver (baseline) and then at 4 to 5 months post baseline we will collect data. At the end of the post data collection, the control group will get all of the study materials from both the sexual health and alcohol prevention groups.
Sexual Health and Alcohol Control Group (Teen)
Parents of teens between the ages of 14 and 15 will receive their usual care at their well-child visit appointment with their primary care giver (baseline) and then at 4 to 5 months post baseline we will collect data. At the end of the post data collection, the control group will get all of the study materials from both the sexual health and alcohol prevention groups.
Parent-teen Communication About Reasons the Teen Wants to Drive
2.32 units on a scale
Standard Deviation .89
1.75 units on a scale
Standard Deviation .90

PRIMARY outcome

Timeframe: 6 months post-enrollment

Population: Parent Population

Six months after baseline, parents reported on the frequency that they talked about the kinds of risky driving situations that might come up in his or her friend group. Parents selected from one of the following response choices: "never talked about" (0); "talked about once or twice" (1); "talked about three or four times" (2); "talked about a lot, about 5 times or more" (3).

Outcome measures

Outcome measures
Measure
Sexual Health (Parent)
n=22 Participants
Parents of teens between the ages of 14 and 15 will review psychoeducational workbooks related to sexual health at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials. Sexual Health: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about sexual health, sexually transmitted disease (STD) prevention, and safe sex practices for teenager.
Sexual Health (Teen)
n=24 Participants
Teens between the ages of 14 and 15 will review psychoeducational workbooks related to sexual health at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials. Sexual Health: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about sexual health, sexually transmitted disease (STD) prevention, and safe sex practices for teenager.
Alcohol Prevention (Parent)
Parents of teens between the ages of 14 and 15 will review psychoeducational workbooks related to alcohol prevention at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials. Alcohol Prevention: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about alcohol prevention and safety, underage drinking, and drinking and driving.
Alcohol (Teen)
Parents of teens between the ages of 14 and 15 will review psychoeducational workbooks related to alcohol prevention at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials. Alcohol Prevention: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about alcohol prevention and safety, underage drinking, and drinking and driving.
Sexual Health & Alcohol Control Group (Parent)
Parents of teens between the ages of 14 and 15 will receive their usual care at their well-child visit appointment with their primary care giver (baseline) and then at 4 to 5 months post baseline we will collect data. At the end of the post data collection, the control group will get all of the study materials from both the sexual health and alcohol prevention groups.
Sexual Health and Alcohol Control Group (Teen)
Parents of teens between the ages of 14 and 15 will receive their usual care at their well-child visit appointment with their primary care giver (baseline) and then at 4 to 5 months post baseline we will collect data. At the end of the post data collection, the control group will get all of the study materials from both the sexual health and alcohol prevention groups.
Parent-teen Communication About the Kinds of Risky Driving Situations That Might Come up in His or Her Friend Group
2.59 units on a scale
Standard Deviation .73
1.79 units on a scale
Standard Deviation .98

PRIMARY outcome

Timeframe: 6 months post-enrollment

Population: Parent Population

Six months after baseline, parents reported on the frequency that they talked about about Pennsylvania's GDL laws. Parents selected from one of the following response choices: "never talked about" (0); "talked about once or twice" (1); "talked about three or four times" (2); "talked about a lot, about 5 times or more" (3).

Outcome measures

Outcome measures
Measure
Sexual Health (Parent)
n=22 Participants
Parents of teens between the ages of 14 and 15 will review psychoeducational workbooks related to sexual health at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials. Sexual Health: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about sexual health, sexually transmitted disease (STD) prevention, and safe sex practices for teenager.
Sexual Health (Teen)
n=24 Participants
Teens between the ages of 14 and 15 will review psychoeducational workbooks related to sexual health at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials. Sexual Health: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about sexual health, sexually transmitted disease (STD) prevention, and safe sex practices for teenager.
Alcohol Prevention (Parent)
Parents of teens between the ages of 14 and 15 will review psychoeducational workbooks related to alcohol prevention at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials. Alcohol Prevention: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about alcohol prevention and safety, underage drinking, and drinking and driving.
Alcohol (Teen)
Parents of teens between the ages of 14 and 15 will review psychoeducational workbooks related to alcohol prevention at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials. Alcohol Prevention: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about alcohol prevention and safety, underage drinking, and drinking and driving.
Sexual Health & Alcohol Control Group (Parent)
Parents of teens between the ages of 14 and 15 will receive their usual care at their well-child visit appointment with their primary care giver (baseline) and then at 4 to 5 months post baseline we will collect data. At the end of the post data collection, the control group will get all of the study materials from both the sexual health and alcohol prevention groups.
Sexual Health and Alcohol Control Group (Teen)
Parents of teens between the ages of 14 and 15 will receive their usual care at their well-child visit appointment with their primary care giver (baseline) and then at 4 to 5 months post baseline we will collect data. At the end of the post data collection, the control group will get all of the study materials from both the sexual health and alcohol prevention groups.
Parent-teen Communication About Pennsylvania's Graduated Driver Licensing Laws
1.82 units on a scale
Standard Deviation .85
.71 units on a scale
Standard Deviation 1.08

PRIMARY outcome

Timeframe: 6 months post-enrollment

Population: Parent Population

Six months after baseline, parents reported on the frequency that they talked about wearing a seatbelt. Parents selected from one of the following response choices: "never talked about" (0); "talked about once or twice" (1); "talked about three or four times" (2); "talked about a lot, about 5 times or more" (3).

Outcome measures

Outcome measures
Measure
Sexual Health (Parent)
n=22 Participants
Parents of teens between the ages of 14 and 15 will review psychoeducational workbooks related to sexual health at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials. Sexual Health: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about sexual health, sexually transmitted disease (STD) prevention, and safe sex practices for teenager.
Sexual Health (Teen)
n=24 Participants
Teens between the ages of 14 and 15 will review psychoeducational workbooks related to sexual health at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials. Sexual Health: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about sexual health, sexually transmitted disease (STD) prevention, and safe sex practices for teenager.
Alcohol Prevention (Parent)
Parents of teens between the ages of 14 and 15 will review psychoeducational workbooks related to alcohol prevention at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials. Alcohol Prevention: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about alcohol prevention and safety, underage drinking, and drinking and driving.
Alcohol (Teen)
Parents of teens between the ages of 14 and 15 will review psychoeducational workbooks related to alcohol prevention at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials. Alcohol Prevention: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about alcohol prevention and safety, underage drinking, and drinking and driving.
Sexual Health & Alcohol Control Group (Parent)
Parents of teens between the ages of 14 and 15 will receive their usual care at their well-child visit appointment with their primary care giver (baseline) and then at 4 to 5 months post baseline we will collect data. At the end of the post data collection, the control group will get all of the study materials from both the sexual health and alcohol prevention groups.
Sexual Health and Alcohol Control Group (Teen)
Parents of teens between the ages of 14 and 15 will receive their usual care at their well-child visit appointment with their primary care giver (baseline) and then at 4 to 5 months post baseline we will collect data. At the end of the post data collection, the control group will get all of the study materials from both the sexual health and alcohol prevention groups.
Parent-teen Communication About Wearing a Seatbelt
2.68 units on a scale
Standard Deviation .72
2.79 units on a scale
Standard Deviation .59

PRIMARY outcome

Timeframe: 6 months post-enrollment

Population: Parent Population

Six months after baseline, parents reported on the frequency that they talked about dangers of distracted driving. Parents selected from one of the following response choices: "never talked about" (0); "talked about once or twice" (1); "talked about three or four times" (2); "talked about a lot, about 5 times or more" (3).

Outcome measures

Outcome measures
Measure
Sexual Health (Parent)
n=22 Participants
Parents of teens between the ages of 14 and 15 will review psychoeducational workbooks related to sexual health at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials. Sexual Health: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about sexual health, sexually transmitted disease (STD) prevention, and safe sex practices for teenager.
Sexual Health (Teen)
n=24 Participants
Teens between the ages of 14 and 15 will review psychoeducational workbooks related to sexual health at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials. Sexual Health: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about sexual health, sexually transmitted disease (STD) prevention, and safe sex practices for teenager.
Alcohol Prevention (Parent)
Parents of teens between the ages of 14 and 15 will review psychoeducational workbooks related to alcohol prevention at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials. Alcohol Prevention: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about alcohol prevention and safety, underage drinking, and drinking and driving.
Alcohol (Teen)
Parents of teens between the ages of 14 and 15 will review psychoeducational workbooks related to alcohol prevention at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials. Alcohol Prevention: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about alcohol prevention and safety, underage drinking, and drinking and driving.
Sexual Health & Alcohol Control Group (Parent)
Parents of teens between the ages of 14 and 15 will receive their usual care at their well-child visit appointment with their primary care giver (baseline) and then at 4 to 5 months post baseline we will collect data. At the end of the post data collection, the control group will get all of the study materials from both the sexual health and alcohol prevention groups.
Sexual Health and Alcohol Control Group (Teen)
Parents of teens between the ages of 14 and 15 will receive their usual care at their well-child visit appointment with their primary care giver (baseline) and then at 4 to 5 months post baseline we will collect data. At the end of the post data collection, the control group will get all of the study materials from both the sexual health and alcohol prevention groups.
Parent-teen Communication About Dangers of Distracted Driving
2.77 units on a scale
Standard Deviation .43
2.63 units on a scale
Standard Deviation .71

PRIMARY outcome

Timeframe: 6 months post-enrollment

Population: Parent Population

Six months after baseline, parents reported on the frequency that they talked about being a safe passenger. Parents selected from one of the following response choices: "never talked about" (0); "talked about once or twice" (1); "talked about three or four times" (2); "talked about a lot, about 5 times or more" (3).

Outcome measures

Outcome measures
Measure
Sexual Health (Parent)
n=22 Participants
Parents of teens between the ages of 14 and 15 will review psychoeducational workbooks related to sexual health at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials. Sexual Health: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about sexual health, sexually transmitted disease (STD) prevention, and safe sex practices for teenager.
Sexual Health (Teen)
n=24 Participants
Teens between the ages of 14 and 15 will review psychoeducational workbooks related to sexual health at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials. Sexual Health: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about sexual health, sexually transmitted disease (STD) prevention, and safe sex practices for teenager.
Alcohol Prevention (Parent)
Parents of teens between the ages of 14 and 15 will review psychoeducational workbooks related to alcohol prevention at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials. Alcohol Prevention: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about alcohol prevention and safety, underage drinking, and drinking and driving.
Alcohol (Teen)
Parents of teens between the ages of 14 and 15 will review psychoeducational workbooks related to alcohol prevention at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials. Alcohol Prevention: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about alcohol prevention and safety, underage drinking, and drinking and driving.
Sexual Health & Alcohol Control Group (Parent)
Parents of teens between the ages of 14 and 15 will receive their usual care at their well-child visit appointment with their primary care giver (baseline) and then at 4 to 5 months post baseline we will collect data. At the end of the post data collection, the control group will get all of the study materials from both the sexual health and alcohol prevention groups.
Sexual Health and Alcohol Control Group (Teen)
Parents of teens between the ages of 14 and 15 will receive their usual care at their well-child visit appointment with their primary care giver (baseline) and then at 4 to 5 months post baseline we will collect data. At the end of the post data collection, the control group will get all of the study materials from both the sexual health and alcohol prevention groups.
Parent-teen Communication About Being a Safe Passenger
2.55 units on a scale
Standard Deviation .67
1.71 units on a scale
Standard Deviation 1.27

PRIMARY outcome

Timeframe: 6 months post-enrollment

Population: Parent Population

Six months after baseline, parents reported on the frequency that they talked about what to do in a crash. Parents selected from one of the following response choices: "never talked about" (0); "talked about once or twice" (1); "talked about three or four times" (2); "talked about a lot, about 5 times or more" (3).

Outcome measures

Outcome measures
Measure
Sexual Health (Parent)
n=22 Participants
Parents of teens between the ages of 14 and 15 will review psychoeducational workbooks related to sexual health at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials. Sexual Health: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about sexual health, sexually transmitted disease (STD) prevention, and safe sex practices for teenager.
Sexual Health (Teen)
n=24 Participants
Teens between the ages of 14 and 15 will review psychoeducational workbooks related to sexual health at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials. Sexual Health: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about sexual health, sexually transmitted disease (STD) prevention, and safe sex practices for teenager.
Alcohol Prevention (Parent)
Parents of teens between the ages of 14 and 15 will review psychoeducational workbooks related to alcohol prevention at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials. Alcohol Prevention: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about alcohol prevention and safety, underage drinking, and drinking and driving.
Alcohol (Teen)
Parents of teens between the ages of 14 and 15 will review psychoeducational workbooks related to alcohol prevention at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials. Alcohol Prevention: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about alcohol prevention and safety, underage drinking, and drinking and driving.
Sexual Health & Alcohol Control Group (Parent)
Parents of teens between the ages of 14 and 15 will receive their usual care at their well-child visit appointment with their primary care giver (baseline) and then at 4 to 5 months post baseline we will collect data. At the end of the post data collection, the control group will get all of the study materials from both the sexual health and alcohol prevention groups.
Sexual Health and Alcohol Control Group (Teen)
Parents of teens between the ages of 14 and 15 will receive their usual care at their well-child visit appointment with their primary care giver (baseline) and then at 4 to 5 months post baseline we will collect data. At the end of the post data collection, the control group will get all of the study materials from both the sexual health and alcohol prevention groups.
Parent-teen Communication About What to do in a Crash
2.00 units on a scale
Standard Deviation 1.23
.46 units on a scale
Standard Deviation .83

PRIMARY outcome

Timeframe: 6 months post-enrollment

Population: Parent Population

Six months after baseline, parents reported on the frequency that they talked about what to do if stopped by a police officer. Parents selected from one of the following response choices: "never talked about" (0); "talked about once or twice" (1); "talked about three or four times" (2); "talked about a lot, about 5 times or more" (3).

Outcome measures

Outcome measures
Measure
Sexual Health (Parent)
n=22 Participants
Parents of teens between the ages of 14 and 15 will review psychoeducational workbooks related to sexual health at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials. Sexual Health: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about sexual health, sexually transmitted disease (STD) prevention, and safe sex practices for teenager.
Sexual Health (Teen)
n=24 Participants
Teens between the ages of 14 and 15 will review psychoeducational workbooks related to sexual health at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials. Sexual Health: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about sexual health, sexually transmitted disease (STD) prevention, and safe sex practices for teenager.
Alcohol Prevention (Parent)
Parents of teens between the ages of 14 and 15 will review psychoeducational workbooks related to alcohol prevention at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials. Alcohol Prevention: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about alcohol prevention and safety, underage drinking, and drinking and driving.
Alcohol (Teen)
Parents of teens between the ages of 14 and 15 will review psychoeducational workbooks related to alcohol prevention at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials. Alcohol Prevention: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about alcohol prevention and safety, underage drinking, and drinking and driving.
Sexual Health & Alcohol Control Group (Parent)
Parents of teens between the ages of 14 and 15 will receive their usual care at their well-child visit appointment with their primary care giver (baseline) and then at 4 to 5 months post baseline we will collect data. At the end of the post data collection, the control group will get all of the study materials from both the sexual health and alcohol prevention groups.
Sexual Health and Alcohol Control Group (Teen)
Parents of teens between the ages of 14 and 15 will receive their usual care at their well-child visit appointment with their primary care giver (baseline) and then at 4 to 5 months post baseline we will collect data. At the end of the post data collection, the control group will get all of the study materials from both the sexual health and alcohol prevention groups.
Parent-teen Communication About What to do if Stopped by a Police Officer
2.27 units on a scale
Standard Deviation .88
1.25 units on a scale
Standard Deviation 1.07

PRIMARY outcome

Timeframe: 6 months post-enrollment

Population: Parent Population

Six months after baseline, parents reported on the frequency that they talked about driving under the influence of drugs or alcohol. Parents selected from one of the following response choices: "never talked about" (0); "talked about once or twice" (1); "talked about three or four times" (2); "talked about a lot, about 5 times or more" (3).

Outcome measures

Outcome measures
Measure
Sexual Health (Parent)
n=22 Participants
Parents of teens between the ages of 14 and 15 will review psychoeducational workbooks related to sexual health at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials. Sexual Health: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about sexual health, sexually transmitted disease (STD) prevention, and safe sex practices for teenager.
Sexual Health (Teen)
n=24 Participants
Teens between the ages of 14 and 15 will review psychoeducational workbooks related to sexual health at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials. Sexual Health: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about sexual health, sexually transmitted disease (STD) prevention, and safe sex practices for teenager.
Alcohol Prevention (Parent)
Parents of teens between the ages of 14 and 15 will review psychoeducational workbooks related to alcohol prevention at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials. Alcohol Prevention: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about alcohol prevention and safety, underage drinking, and drinking and driving.
Alcohol (Teen)
Parents of teens between the ages of 14 and 15 will review psychoeducational workbooks related to alcohol prevention at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials. Alcohol Prevention: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about alcohol prevention and safety, underage drinking, and drinking and driving.
Sexual Health & Alcohol Control Group (Parent)
Parents of teens between the ages of 14 and 15 will receive their usual care at their well-child visit appointment with their primary care giver (baseline) and then at 4 to 5 months post baseline we will collect data. At the end of the post data collection, the control group will get all of the study materials from both the sexual health and alcohol prevention groups.
Sexual Health and Alcohol Control Group (Teen)
Parents of teens between the ages of 14 and 15 will receive their usual care at their well-child visit appointment with their primary care giver (baseline) and then at 4 to 5 months post baseline we will collect data. At the end of the post data collection, the control group will get all of the study materials from both the sexual health and alcohol prevention groups.
Parent-teen Communication About Driving Under the Influence of Drugs or Alcohol
1.73 units on a scale
Standard Deviation 1.16
1.21 units on a scale
Standard Deviation 1.29

PRIMARY outcome

Timeframe: 6 months post-enrollment

Population: Parent Population

Six months after baseline, parents reported on the frequency that they talked about what to do if the teen needs a safe ride home. Parents selected from one of the following response choices: "never talked about" (0); "talked about once or twice" (1); "talked about three or four times" (2); "talked about a lot, about 5 times or more" (3).

Outcome measures

Outcome measures
Measure
Sexual Health (Parent)
n=22 Participants
Parents of teens between the ages of 14 and 15 will review psychoeducational workbooks related to sexual health at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials. Sexual Health: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about sexual health, sexually transmitted disease (STD) prevention, and safe sex practices for teenager.
Sexual Health (Teen)
n=24 Participants
Teens between the ages of 14 and 15 will review psychoeducational workbooks related to sexual health at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials. Sexual Health: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about sexual health, sexually transmitted disease (STD) prevention, and safe sex practices for teenager.
Alcohol Prevention (Parent)
Parents of teens between the ages of 14 and 15 will review psychoeducational workbooks related to alcohol prevention at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials. Alcohol Prevention: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about alcohol prevention and safety, underage drinking, and drinking and driving.
Alcohol (Teen)
Parents of teens between the ages of 14 and 15 will review psychoeducational workbooks related to alcohol prevention at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials. Alcohol Prevention: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about alcohol prevention and safety, underage drinking, and drinking and driving.
Sexual Health & Alcohol Control Group (Parent)
Parents of teens between the ages of 14 and 15 will receive their usual care at their well-child visit appointment with their primary care giver (baseline) and then at 4 to 5 months post baseline we will collect data. At the end of the post data collection, the control group will get all of the study materials from both the sexual health and alcohol prevention groups.
Sexual Health and Alcohol Control Group (Teen)
Parents of teens between the ages of 14 and 15 will receive their usual care at their well-child visit appointment with their primary care giver (baseline) and then at 4 to 5 months post baseline we will collect data. At the end of the post data collection, the control group will get all of the study materials from both the sexual health and alcohol prevention groups.
Parent-teen Communication About What to do if the Teen Needs a Safe Ride Home
2.45 units on a scale
Standard Deviation .86
1.96 units on a scale
Standard Deviation 1.20

PRIMARY outcome

Timeframe: 6 months post-enrollment

Population: Parent Population

Six months after baseline, parents reported on the frequency that they talked about stopping a friend from driving under the influence of drugs or alcohol. Parents selected from one of the following response choices: "never talked about" (0); "talked about once or twice" (1); "talked about three or four times" (2); "talked about a lot, about 5 times or more" (3).stopping a friend from riding with a driver who is under the influence of drugs or alcohol

Outcome measures

Outcome measures
Measure
Sexual Health (Parent)
n=22 Participants
Parents of teens between the ages of 14 and 15 will review psychoeducational workbooks related to sexual health at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials. Sexual Health: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about sexual health, sexually transmitted disease (STD) prevention, and safe sex practices for teenager.
Sexual Health (Teen)
n=24 Participants
Teens between the ages of 14 and 15 will review psychoeducational workbooks related to sexual health at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials. Sexual Health: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about sexual health, sexually transmitted disease (STD) prevention, and safe sex practices for teenager.
Alcohol Prevention (Parent)
Parents of teens between the ages of 14 and 15 will review psychoeducational workbooks related to alcohol prevention at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials. Alcohol Prevention: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about alcohol prevention and safety, underage drinking, and drinking and driving.
Alcohol (Teen)
Parents of teens between the ages of 14 and 15 will review psychoeducational workbooks related to alcohol prevention at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials. Alcohol Prevention: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about alcohol prevention and safety, underage drinking, and drinking and driving.
Sexual Health & Alcohol Control Group (Parent)
Parents of teens between the ages of 14 and 15 will receive their usual care at their well-child visit appointment with their primary care giver (baseline) and then at 4 to 5 months post baseline we will collect data. At the end of the post data collection, the control group will get all of the study materials from both the sexual health and alcohol prevention groups.
Sexual Health and Alcohol Control Group (Teen)
Parents of teens between the ages of 14 and 15 will receive their usual care at their well-child visit appointment with their primary care giver (baseline) and then at 4 to 5 months post baseline we will collect data. At the end of the post data collection, the control group will get all of the study materials from both the sexual health and alcohol prevention groups.
Parent-teen Communication About Stopping a Friend From Driving Under the Influence of Drugs or Alcohol
2.64 units on a scale
Standard Deviation .66
2.29 units on a scale
Standard Deviation .955

PRIMARY outcome

Timeframe: 6 months post-enrollment

Population: Parent Population

Six months after baseline, parents reported on the frequency that they talked about stopping a friend from riding with a driver who is under the influence of drugs or alcohol. Parents selected from one of the following response choices: "never talked about" (0); "talked about once or twice" (1); "talked about three or four times" (2); "talked about a lot, about 5 times or more" (3).

Outcome measures

Outcome measures
Measure
Sexual Health (Parent)
n=22 Participants
Parents of teens between the ages of 14 and 15 will review psychoeducational workbooks related to sexual health at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials. Sexual Health: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about sexual health, sexually transmitted disease (STD) prevention, and safe sex practices for teenager.
Sexual Health (Teen)
n=24 Participants
Teens between the ages of 14 and 15 will review psychoeducational workbooks related to sexual health at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials. Sexual Health: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about sexual health, sexually transmitted disease (STD) prevention, and safe sex practices for teenager.
Alcohol Prevention (Parent)
Parents of teens between the ages of 14 and 15 will review psychoeducational workbooks related to alcohol prevention at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials. Alcohol Prevention: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about alcohol prevention and safety, underage drinking, and drinking and driving.
Alcohol (Teen)
Parents of teens between the ages of 14 and 15 will review psychoeducational workbooks related to alcohol prevention at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials. Alcohol Prevention: Psychoeducational workbook, worksheets, tip sheets, and health coaching session about alcohol prevention and safety, underage drinking, and drinking and driving.
Sexual Health & Alcohol Control Group (Parent)
Parents of teens between the ages of 14 and 15 will receive their usual care at their well-child visit appointment with their primary care giver (baseline) and then at 4 to 5 months post baseline we will collect data. At the end of the post data collection, the control group will get all of the study materials from both the sexual health and alcohol prevention groups.
Sexual Health and Alcohol Control Group (Teen)
Parents of teens between the ages of 14 and 15 will receive their usual care at their well-child visit appointment with their primary care giver (baseline) and then at 4 to 5 months post baseline we will collect data. At the end of the post data collection, the control group will get all of the study materials from both the sexual health and alcohol prevention groups.
Parent-teen Communication About Stopping a Friend From Riding With a Driver Who is Under the Influence of Drugs or Alcohol
1.68 units on a scale
Standard Deviation 1.17
.71 units on a scale
Standard Deviation 1.12

Adverse Events

Sexual Health

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Alcohol Prevention

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Sexual Health & Alcohol Control Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Teen Driving

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Teen Driving Control

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Carol Ford

Children's Hospital of Philadelphia

Phone: 267-426-3938

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place