Trial Outcomes & Findings for Improving the Reproductive Health of Families (NCT NCT03858803)
NCT ID: NCT03858803
Last Updated: 2025-08-17
Results Overview
Self-reported frequency of unprotected intercourse occasions in past 3 months.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
945 participants
Primary outcome timeframe
6 month
Results posted on
2025-08-17
Participant Flow
Participant milestones
| Measure |
FM2 First, LAST Delayed - Youth
Parent intervention, Families Matter 2 (FM2), immediate, adolescent intervention, Living as a Safer Teen (LAST), delayed six months
Families Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.
Living as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.
|
FM2 First, LAST Delayed - Parents
Parent intervention, Families Matter 2 (FM2), immediate, adolescent intervention, Living as a Safer Teen (LAST), delayed six months
Families Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.
Living as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.
|
FM2 and LAST Simultaneous - Youth
Parents participate in Families Matter 2 (FM2) and adolescents in Living as a Safer Teen (LAST) intervention immediately following the baseline assessment.
Families Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.
Living as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.
|
FM2 and LAST Simultaneous - Parents
Parents participate in Families Matter 2 (FM2) and adolescents in Living as a Safer Teen (LAST) intervention immediately following the baseline assessment.
Families Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.
Living as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.
|
Comparison Arm - Youth
Comparison arm in which both parents and adolescents will be offered their respective interventions following the final assessment. Following the final assessment parents will be offered the Families Matter (FM2) intervention and youth the Living as a Safer Teen (LAST) intervention as an ethically justified service.
Families Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.
Living as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.
|
Comparison Arm - Parents
Comparison arm in which both parents and adolescents will be offered their respective interventions following the final assessment. Following the final assessment parents will be offered the Families Matter (FM2) intervention and youth the Living as a Safer Teen (LAST) intervention as an ethically justified service.
Families Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.
Living as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
161
|
161
|
158
|
160
|
153
|
152
|
|
Overall Study
Post
|
161
|
161
|
158
|
160
|
153
|
152
|
|
Overall Study
COMPLETED
|
148
|
151
|
153
|
155
|
149
|
149
|
|
Overall Study
NOT COMPLETED
|
13
|
10
|
5
|
5
|
4
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Improving the Reproductive Health of Families
Baseline characteristics by cohort
| Measure |
FM2 First, LAST Delayed - Youth
n=161 Participants
Parent intervention, Families Matter 2 (FM2), immediate, adolescent intervention, Living as a Safer Teen (LAST), delayed six months
Families Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.
Living as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.
|
FM2 and LAST Simultaneous - Youth
n=158 Participants
Parents participate in Families Matter 2 (FM2) and adolescents in Living as a Safer Teen (LAST) intervention immediately following the baseline assessment.
Families Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.
Living as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.
|
Comparison Arm - Youth
n=153 Participants
Comparison arm in which both parents and adolescents will be offered their respective interventions following the final assessment. Following the final assessment parents will be offered the Families Matter (FM2) intervention and youth the Living as a Safer Teen (LAST) intervention as an ethically justified service.
Families Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.
Living as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.
|
FM2 First, LAST Delayed - Parents
n=161 Participants
Parent intervention, Families Matter 2 (FM2), immediate, adolescent intervention, Living as a Safer Teen (LAST), delayed six months
Families Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.
Living as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.
|
FM2 and LAST Simultaneous - Parents
n=160 Participants
Parents participate in Families Matter 2 (FM2) and adolescents in Living as a Safer Teen (LAST) intervention immediately following the baseline assessment.
Families Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.
Living as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.
|
Comparison Arm - Parents
n=152 Participants
Comparison arm in which both parents and adolescents will be offered their respective interventions following the final assessment. Following the final assessment parents will be offered the Families Matter (FM2) intervention and youth the Living as a Safer Teen (LAST) intervention as an ethically justified service.
|
Total
n=945 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
161 Participants
n=99 Participants
|
158 Participants
n=107 Participants
|
153 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
477 Participants
n=3 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
154 Participants
n=7 Participants
|
153 Participants
n=31 Participants
|
143 Participants
n=30 Participants
|
450 Participants
n=3 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
7 Participants
n=30 Participants
|
18 Participants
n=3 Participants
|
|
Age, Continuous
|
15.1 years
STANDARD_DEVIATION 1.7 • n=99 Participants
|
15.26 years
STANDARD_DEVIATION 1.5 • n=107 Participants
|
15.00 years
STANDARD_DEVIATION 1.7 • n=206 Participants
|
41.95 years
STANDARD_DEVIATION 9.12 • n=7 Participants
|
38.56 years
STANDARD_DEVIATION 9.34 • n=31 Participants
|
41.03 years
STANDARD_DEVIATION 9.79 • n=30 Participants
|
27.83 years
STANDARD_DEVIATION 12.74 • n=3 Participants
|
|
Sex: Female, Male
Female
|
95 Participants
n=99 Participants
|
86 Participants
n=107 Participants
|
84 Participants
n=206 Participants
|
142 Participants
n=7 Participants
|
143 Participants
n=31 Participants
|
139 Participants
n=30 Participants
|
689 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
66 Participants
n=99 Participants
|
72 Participants
n=107 Participants
|
69 Participants
n=206 Participants
|
19 Participants
n=7 Participants
|
17 Participants
n=31 Participants
|
13 Participants
n=30 Participants
|
256 Participants
n=3 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
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
|
|
Race (NIH/OMB)
Asian
|
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
|
|
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
|
|
Race (NIH/OMB)
Black or African American
|
161 Participants
n=99 Participants
|
158 Participants
n=107 Participants
|
153 Participants
n=206 Participants
|
161 Participants
n=7 Participants
|
160 Participants
n=31 Participants
|
152 Participants
n=30 Participants
|
945 Participants
n=3 Participants
|
|
Race (NIH/OMB)
White
|
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
|
|
Race (NIH/OMB)
More than one race
|
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
|
|
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
|
|
Region of Enrollment
Botswana
|
161 participants
n=99 Participants
|
158 participants
n=107 Participants
|
153 participants
n=206 Participants
|
161 participants
n=7 Participants
|
160 participants
n=31 Participants
|
152 participants
n=30 Participants
|
945 participants
n=3 Participants
|
|
Parental Monitoring
|
9.51 units on a scale
STANDARD_DEVIATION 3.75 • n=99 Participants
|
10.03 units on a scale
STANDARD_DEVIATION 4.25 • n=107 Participants
|
9.62 units on a scale
STANDARD_DEVIATION 4.24 • n=206 Participants
|
8.35 units on a scale
STANDARD_DEVIATION 4.22 • n=7 Participants
|
8.38 units on a scale
STANDARD_DEVIATION 4.48 • n=31 Participants
|
8.20 units on a scale
STANDARD_DEVIATION 4.63 • n=30 Participants
|
9.02 units on a scale
STANDARD_DEVIATION .72 • n=3 Participants
|
PRIMARY outcome
Timeframe: 6 monthSelf-reported frequency of unprotected intercourse occasions in past 3 months.
Outcome measures
| Measure |
FM2 First, LAST Delayed
n=148 Participants
Parent intervention, Families Matter 2 (FM2), immediate, adolescent intervention, Living as a Safer Teen (LAST), delayed six months
Families Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.
Living as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.
|
FM2 and LAST Simultaneous
n=153 Participants
Parents participate in Families Matter 2 (FM2) and adolescents in Living as a Safer Teen (LAST) intervention immediately following the baseline assessment.
Families Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.
Living as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.
|
Comparison Arm
n=149 Participants
Comparison arm in which both parents and adolescents will be offered their respective interventions following the final assessment. Following the final assessment parents will be offered the Families Matter (FM2) intervention and youth the Living as a Safer Teen (LAST) intervention as an ethically justified service.
Families Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.
Living as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.
|
|---|---|---|---|
|
Changes in Frequency of Unprotected Intercourse (Youth)
|
1.42 number of occassions
Standard Deviation 3.09
|
1.16 number of occassions
Standard Deviation 1.78
|
1.38 number of occassions
Standard Deviation 2.93
|
PRIMARY outcome
Timeframe: 6 monthMeasure of knowledge about prevention of STIs, HIV, and pregnancy. Total score range 0-26. No subscales. Higher scores reflect more accurate knowledge.
Outcome measures
| Measure |
FM2 First, LAST Delayed
n=148 Participants
Parent intervention, Families Matter 2 (FM2), immediate, adolescent intervention, Living as a Safer Teen (LAST), delayed six months
Families Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.
Living as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.
|
FM2 and LAST Simultaneous
n=153 Participants
Parents participate in Families Matter 2 (FM2) and adolescents in Living as a Safer Teen (LAST) intervention immediately following the baseline assessment.
Families Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.
Living as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.
|
Comparison Arm
n=149 Participants
Comparison arm in which both parents and adolescents will be offered their respective interventions following the final assessment. Following the final assessment parents will be offered the Families Matter (FM2) intervention and youth the Living as a Safer Teen (LAST) intervention as an ethically justified service.
Families Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.
Living as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.
|
|---|---|---|---|
|
Changes in Reproductive Health Knowledge Test Scores (Youth)
|
12.79 score on a scale
Standard Deviation 6.32
|
14.66 score on a scale
Standard Deviation 6.90
|
11.37 score on a scale
Standard Deviation 5.99
|
PRIMARY outcome
Timeframe: 6 monthTotal score range 0 - 140; Higher scores reflect greater perceived barriers to condom use. No subscales
Outcome measures
| Measure |
FM2 First, LAST Delayed
n=148 Participants
Parent intervention, Families Matter 2 (FM2), immediate, adolescent intervention, Living as a Safer Teen (LAST), delayed six months
Families Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.
Living as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.
|
FM2 and LAST Simultaneous
n=153 Participants
Parents participate in Families Matter 2 (FM2) and adolescents in Living as a Safer Teen (LAST) intervention immediately following the baseline assessment.
Families Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.
Living as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.
|
Comparison Arm
n=149 Participants
Comparison arm in which both parents and adolescents will be offered their respective interventions following the final assessment. Following the final assessment parents will be offered the Families Matter (FM2) intervention and youth the Living as a Safer Teen (LAST) intervention as an ethically justified service.
Families Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.
Living as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.
|
|---|---|---|---|
|
Changes in Condom Barriers Scale(Youth)
|
63.67 score on a scale
Standard Deviation 20.08
|
57.73 score on a scale
Standard Deviation 22.30
|
66.37 score on a scale
Standard Deviation 19.12
|
PRIMARY outcome
Timeframe: 6 monthTotal score range 0 - 120, No subscales, Higher scores reflect more acceptance of transactional sex
Outcome measures
| Measure |
FM2 First, LAST Delayed
n=148 Participants
Parent intervention, Families Matter 2 (FM2), immediate, adolescent intervention, Living as a Safer Teen (LAST), delayed six months
Families Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.
Living as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.
|
FM2 and LAST Simultaneous
n=153 Participants
Parents participate in Families Matter 2 (FM2) and adolescents in Living as a Safer Teen (LAST) intervention immediately following the baseline assessment.
Families Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.
Living as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.
|
Comparison Arm
n=149 Participants
Comparison arm in which both parents and adolescents will be offered their respective interventions following the final assessment. Following the final assessment parents will be offered the Families Matter (FM2) intervention and youth the Living as a Safer Teen (LAST) intervention as an ethically justified service.
Families Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.
Living as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.
|
|---|---|---|---|
|
Change in Attitudes Toward Transactional Sex Scale (Youth)
|
19.67 score on a scale
Standard Deviation 12.93
|
20.44 score on a scale
Standard Deviation 13.49
|
23.18 score on a scale
Standard Deviation 14.70
|
PRIMARY outcome
Timeframe: 6 monthsChange in self-reported numbers of sex partners in past two months
Outcome measures
| Measure |
FM2 First, LAST Delayed
n=148 Participants
Parent intervention, Families Matter 2 (FM2), immediate, adolescent intervention, Living as a Safer Teen (LAST), delayed six months
Families Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.
Living as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.
|
FM2 and LAST Simultaneous
n=153 Participants
Parents participate in Families Matter 2 (FM2) and adolescents in Living as a Safer Teen (LAST) intervention immediately following the baseline assessment.
Families Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.
Living as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.
|
Comparison Arm
n=149 Participants
Comparison arm in which both parents and adolescents will be offered their respective interventions following the final assessment. Following the final assessment parents will be offered the Families Matter (FM2) intervention and youth the Living as a Safer Teen (LAST) intervention as an ethically justified service.
Families Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.
Living as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.
|
|---|---|---|---|
|
Change in Number of Sex Partners (Youth)
|
0.91 number of sex partners
Standard Deviation 0.80
|
1.12 number of sex partners
Standard Deviation 2.09
|
2.14 number of sex partners
Standard Deviation 3.59
|
PRIMARY outcome
Timeframe: 6 monthTotal scale range 0-52, No subscales, Higher scores reflect more frequent communication between parent and child frequency
Outcome measures
| Measure |
FM2 First, LAST Delayed
n=148 Participants
Parent intervention, Families Matter 2 (FM2), immediate, adolescent intervention, Living as a Safer Teen (LAST), delayed six months
Families Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.
Living as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.
|
FM2 and LAST Simultaneous
n=153 Participants
Parents participate in Families Matter 2 (FM2) and adolescents in Living as a Safer Teen (LAST) intervention immediately following the baseline assessment.
Families Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.
Living as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.
|
Comparison Arm
n=149 Participants
Comparison arm in which both parents and adolescents will be offered their respective interventions following the final assessment. Following the final assessment parents will be offered the Families Matter (FM2) intervention and youth the Living as a Safer Teen (LAST) intervention as an ethically justified service.
Families Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.
Living as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.
|
|---|---|---|---|
|
Changes on Family Communication Scale (Youth)
|
23.89 score on a scale
Standard Deviation 14.58
|
24.33 score on a scale
Standard Deviation 14.53
|
20.73 score on a scale
Standard Deviation 13.82
|
PRIMARY outcome
Timeframe: 6 monthTotal scale score range 0-144, No subscales, Higher scores reflect more positive attitudes toward condom use
Outcome measures
| Measure |
FM2 First, LAST Delayed
n=148 Participants
Parent intervention, Families Matter 2 (FM2), immediate, adolescent intervention, Living as a Safer Teen (LAST), delayed six months
Families Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.
Living as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.
|
FM2 and LAST Simultaneous
n=153 Participants
Parents participate in Families Matter 2 (FM2) and adolescents in Living as a Safer Teen (LAST) intervention immediately following the baseline assessment.
Families Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.
Living as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.
|
Comparison Arm
n=149 Participants
Comparison arm in which both parents and adolescents will be offered their respective interventions following the final assessment. Following the final assessment parents will be offered the Families Matter (FM2) intervention and youth the Living as a Safer Teen (LAST) intervention as an ethically justified service.
Families Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.
Living as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.
|
|---|---|---|---|
|
Changes in Scores on the Condom Attitudes Scale (Youth)
|
94.40 score on a scale
Standard Deviation 26.50
|
96.65 score on a scale
Standard Deviation 31.00
|
92.09 score on a scale
Standard Deviation 26.85
|
PRIMARY outcome
Timeframe: 6 monthTotal scale score range 0-160, No subscales, Higher scores reflect endorsement of greater self efficacy beliefs
Outcome measures
| Measure |
FM2 First, LAST Delayed
n=148 Participants
Parent intervention, Families Matter 2 (FM2), immediate, adolescent intervention, Living as a Safer Teen (LAST), delayed six months
Families Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.
Living as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.
|
FM2 and LAST Simultaneous
n=153 Participants
Parents participate in Families Matter 2 (FM2) and adolescents in Living as a Safer Teen (LAST) intervention immediately following the baseline assessment.
Families Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.
Living as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.
|
Comparison Arm
n=149 Participants
Comparison arm in which both parents and adolescents will be offered their respective interventions following the final assessment. Following the final assessment parents will be offered the Families Matter (FM2) intervention and youth the Living as a Safer Teen (LAST) intervention as an ethically justified service.
Families Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.
Living as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.
|
|---|---|---|---|
|
Changes in Scores on Self Efficacy Beliefs Scale (Youth)
|
58.99 score on a scale
Standard Deviation 47.29
|
71.82 score on a scale
Standard Deviation 52.68
|
67.83 score on a scale
Standard Deviation 52.05
|
PRIMARY outcome
Timeframe: 6 monthTotal scale score range 0-11, No subscales, Higher scores reflect reports of greater parental responsiveness
Outcome measures
| Measure |
FM2 First, LAST Delayed
n=148 Participants
Parent intervention, Families Matter 2 (FM2), immediate, adolescent intervention, Living as a Safer Teen (LAST), delayed six months
Families Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.
Living as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.
|
FM2 and LAST Simultaneous
n=153 Participants
Parents participate in Families Matter 2 (FM2) and adolescents in Living as a Safer Teen (LAST) intervention immediately following the baseline assessment.
Families Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.
Living as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.
|
Comparison Arm
n=149 Participants
Comparison arm in which both parents and adolescents will be offered their respective interventions following the final assessment. Following the final assessment parents will be offered the Families Matter (FM2) intervention and youth the Living as a Safer Teen (LAST) intervention as an ethically justified service.
Families Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.
Living as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.
|
|---|---|---|---|
|
Changes on Parental Responsiveness Scale (Youth)
|
6.06 score on a scale
Standard Deviation 3.72
|
6.41 score on a scale
Standard Deviation 3.59
|
5.23 score on a scale
Standard Deviation 3.70
|
PRIMARY outcome
Timeframe: 6 monthTotal score range 0-12, No Subscales, Higher score reflect reports of more frequent use of positive reinforcement by parents
Outcome measures
| Measure |
FM2 First, LAST Delayed
n=148 Participants
Parent intervention, Families Matter 2 (FM2), immediate, adolescent intervention, Living as a Safer Teen (LAST), delayed six months
Families Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.
Living as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.
|
FM2 and LAST Simultaneous
n=153 Participants
Parents participate in Families Matter 2 (FM2) and adolescents in Living as a Safer Teen (LAST) intervention immediately following the baseline assessment.
Families Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.
Living as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.
|
Comparison Arm
n=149 Participants
Comparison arm in which both parents and adolescents will be offered their respective interventions following the final assessment. Following the final assessment parents will be offered the Families Matter (FM2) intervention and youth the Living as a Safer Teen (LAST) intervention as an ethically justified service.
Families Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.
Living as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.
|
|---|---|---|---|
|
Changes in Parent Use of Positive Reinforcement Scale (Youth)
|
5.95 score on a scale
Standard Deviation 3.11
|
5.92 score on a scale
Standard Deviation 3.23
|
5.78 score on a scale
Standard Deviation 3.26
|
PRIMARY outcome
Timeframe: 6 monthTotal scale score range 0-16, No subscales, Higher scores reflect report of greater parental monitoring
Outcome measures
| Measure |
FM2 First, LAST Delayed
n=148 Participants
Parent intervention, Families Matter 2 (FM2), immediate, adolescent intervention, Living as a Safer Teen (LAST), delayed six months
Families Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.
Living as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.
|
FM2 and LAST Simultaneous
n=153 Participants
Parents participate in Families Matter 2 (FM2) and adolescents in Living as a Safer Teen (LAST) intervention immediately following the baseline assessment.
Families Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.
Living as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.
|
Comparison Arm
n=149 Participants
Comparison arm in which both parents and adolescents will be offered their respective interventions following the final assessment. Following the final assessment parents will be offered the Families Matter (FM2) intervention and youth the Living as a Safer Teen (LAST) intervention as an ethically justified service.
Families Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.
Living as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.
|
|---|---|---|---|
|
Changes in Parental Monitoring Scale (Youth)
|
9.67 score on a scale
Standard Deviation 3.92
|
9.82 score on a scale
Standard Deviation 4.43
|
10.03 score on a scale
Standard Deviation 3.93
|
Adverse Events
FM2 First, LAST Delayed - Youth
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
FM2 and LAST Simultaneous - Youth
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Comparison Arm - Youth
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
FM2 First, LAST Delayed - Parent
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
FM2 and LAST Simultaneous - Parent
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Comparison Arm - Parent
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place