Trial Outcomes & Findings for Intervention for Teens With ADHD and Substance Use (NCT NCT02502799)
NCT ID: NCT02502799
Last Updated: 2023-03-22
Results Overview
Teen self-report of substance use during the past 90 days
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
158 participants
Primary outcome timeframe
Assessed at 6 months after randomization to treatment
Results posted on
2023-03-22
Participant Flow
All participants received an initial 5-session substance use prevention program. Participants then completed follow-up assessments to determine level of substance use. Participants identified as having non-normative substance use at any follow-up were moved into the second phase of the study and randomly assigned to one of the three treatment groups. Participants who were never identified as having non-normative substance use were considered responders and were not randomized to a treatment arm.
Participant milestones
| Measure |
Continued Monitoring and Assessment
All participants will receive 5 sessions of BEI. Non-responders will then be randomized to one of three conditions. Participants randomized to the continued monitoring and assessment arm will receive no additional intervention. Primary and secondary outcomes will be monitored.
Brief Early Intervention: Adolescents receive 5 individual sessions designed to strengthen the following skills: problem-solving, resisting peer pressure, and coping with emotions. Parents join portions of 3 sessions.
|
PT With ACBT
All participants will receive 5 sessions of BEI. Non-responders will then be randomized to one of three conditions. For participants randomized to the PT with ACBT arm, parents will participate in behavioral parent training (PT) and adolescents will participate in cognitive behavioral therapy to reduce substance use (CBT).
Brief Early Intervention: Adolescents receive 5 individual sessions designed to strengthen the following skills: problem-solving, resisting peer pressure, and coping with emotions. Parents join portions of 3 sessions.
Parent Training with Adolescent Cognitive Behavioral Therapy: Participants receive 12 family sessions with individual adolescent, parent, and joint adolescent and parent time. Includes additional parent training in behavioral modification, adolescent and parent contracting, and adolescent decision-making skills.
|
PT With ACBT and Methylphenidate
All participants will receive 5 sessions of BEI. Non-responders will then be randomized to one of three conditions. For participants randomized to the PT with ACBT and Methylphenidate arm, parents will participate in behavioral parent training (PT) and adolescents will participate in cognitive behavioral therapy to reduce substance use (ACBT). Adolescents will also receive methylphenidate.
Brief Early Intervention: Adolescents receive 5 individual sessions designed to strengthen the following skills: problem-solving, resisting peer pressure, and coping with emotions. Parents join portions of 3 sessions.
Parent Training with Adolescent Cognitive Behavioral Therapy: Participants receive 12 family sessions with individual adolescent, parent, and joint adolescent and parent time. Includes additional parent training in behavioral modification, adolescent and parent contracting, and adolescent decision-making skills.
Methylphenidate: Adolescents will receive methylphenidate.
|
All Participants
All participants for this study were initially assigned to receive the brief 5-session intervention. Six months following completion of that intervention, follow-up assessments took place to assess response to treatment. At that time, participants identified as "Non-responders" to the brief 5-session intervention were randomly assigned to one of three conditions. Participants (n=109) who were identified as "Responders" were never randomized and received no further intervention. The "Responders" also do not have data for phase 2 of this study because they were never randomized to a treatment arm.
|
|---|---|---|---|---|
|
Phase 1: Brief Intervention Sessions
STARTED
|
0
|
0
|
0
|
158
|
|
Phase 1: Brief Intervention Sessions
COMPLETED
|
0
|
0
|
0
|
141
|
|
Phase 1: Brief Intervention Sessions
NOT COMPLETED
|
0
|
0
|
0
|
17
|
|
Phase 2: Intervention Phase
STARTED
|
16
|
17
|
16
|
0
|
|
Phase 2: Intervention Phase
COMPLETED
|
6
|
6
|
7
|
0
|
|
Phase 2: Intervention Phase
NOT COMPLETED
|
10
|
11
|
9
|
0
|
Reasons for withdrawal
| Measure |
Continued Monitoring and Assessment
All participants will receive 5 sessions of BEI. Non-responders will then be randomized to one of three conditions. Participants randomized to the continued monitoring and assessment arm will receive no additional intervention. Primary and secondary outcomes will be monitored.
Brief Early Intervention: Adolescents receive 5 individual sessions designed to strengthen the following skills: problem-solving, resisting peer pressure, and coping with emotions. Parents join portions of 3 sessions.
|
PT With ACBT
All participants will receive 5 sessions of BEI. Non-responders will then be randomized to one of three conditions. For participants randomized to the PT with ACBT arm, parents will participate in behavioral parent training (PT) and adolescents will participate in cognitive behavioral therapy to reduce substance use (CBT).
Brief Early Intervention: Adolescents receive 5 individual sessions designed to strengthen the following skills: problem-solving, resisting peer pressure, and coping with emotions. Parents join portions of 3 sessions.
Parent Training with Adolescent Cognitive Behavioral Therapy: Participants receive 12 family sessions with individual adolescent, parent, and joint adolescent and parent time. Includes additional parent training in behavioral modification, adolescent and parent contracting, and adolescent decision-making skills.
|
PT With ACBT and Methylphenidate
All participants will receive 5 sessions of BEI. Non-responders will then be randomized to one of three conditions. For participants randomized to the PT with ACBT and Methylphenidate arm, parents will participate in behavioral parent training (PT) and adolescents will participate in cognitive behavioral therapy to reduce substance use (ACBT). Adolescents will also receive methylphenidate.
Brief Early Intervention: Adolescents receive 5 individual sessions designed to strengthen the following skills: problem-solving, resisting peer pressure, and coping with emotions. Parents join portions of 3 sessions.
Parent Training with Adolescent Cognitive Behavioral Therapy: Participants receive 12 family sessions with individual adolescent, parent, and joint adolescent and parent time. Includes additional parent training in behavioral modification, adolescent and parent contracting, and adolescent decision-making skills.
Methylphenidate: Adolescents will receive methylphenidate.
|
All Participants
All participants for this study were initially assigned to receive the brief 5-session intervention. Six months following completion of that intervention, follow-up assessments took place to assess response to treatment. At that time, participants identified as "Non-responders" to the brief 5-session intervention were randomly assigned to one of three conditions. Participants (n=109) who were identified as "Responders" were never randomized and received no further intervention. The "Responders" also do not have data for phase 2 of this study because they were never randomized to a treatment arm.
|
|---|---|---|---|---|
|
Phase 1: Brief Intervention Sessions
Lost to Follow-up
|
0
|
0
|
0
|
12
|
|
Phase 1: Brief Intervention Sessions
Early termination of study
|
0
|
0
|
0
|
5
|
|
Phase 2: Intervention Phase
Lost to Follow-up
|
3
|
4
|
1
|
0
|
|
Phase 2: Intervention Phase
Withdrawal by Subject
|
3
|
2
|
3
|
0
|
|
Phase 2: Intervention Phase
Study terminated prior to completion
|
4
|
5
|
5
|
0
|
Baseline Characteristics
Intervention for Teens With ADHD and Substance Use
Baseline characteristics by cohort
| Measure |
Responders (Never Randomized)
n=109 Participants
These participants received the 5 sessions of BEI; however, were never identified as non-responders to the initial intervention and were never randomized to one of the three treatment groups.
|
Continued Monitoring and Assessment
n=16 Participants
All participants will receive 5 sessions of BEI. Non-responders will then be randomized to one of three conditions. Participants randomized to the continued monitoring and assessment arm will receive no additional intervention. Primary and secondary outcomes will be monitored.
Brief Early Intervention: Adolescents receive 5 individual sessions designed to strengthen the following skills: problem-solving, resisting peer pressure, and coping with emotions. Parents join portions of 3 sessions.
|
PT With ACBT
n=17 Participants
All participants will receive 5 sessions of BEI. Non-responders will then be randomized to one of three conditions. For participants randomized to the PT with ACBT arm, parents will participate in behavioral parent training (PT) and adolescents will participate in cognitive behavioral therapy to reduce substance use (CBT).
Brief Early Intervention: Adolescents receive 5 individual sessions designed to strengthen the following skills: problem-solving, resisting peer pressure, and coping with emotions. Parents join portions of 3 sessions.
Parent Training with Adolescent Cognitive Behavioral Therapy: Participants receive 12 family sessions with individual adolescent, parent, and joint adolescent and parent time. Includes additional parent training in behavioral modification, adolescent and parent contracting, and adolescent decision-making skills.
|
PT With ACBT and Methylphenidate
n=16 Participants
All participants will receive 5 sessions of BEI. Non-responders will then be randomized to one of three conditions. For participants randomized to the PT with ACBT and Methylphenidate arm, parents will participate in behavioral parent training (PT) and adolescents will participate in cognitive behavioral therapy to reduce substance use (ACBT). Adolescents will also receive methylphenidate.
Brief Early Intervention: Adolescents receive 5 individual sessions designed to strengthen the following skills: problem-solving, resisting peer pressure, and coping with emotions. Parents join portions of 3 sessions.
Parent Training with Adolescent Cognitive Behavioral Therapy: Participants receive 12 family sessions with individual adolescent, parent, and joint adolescent and parent time. Includes additional parent training in behavioral modification, adolescent and parent contracting, and adolescent decision-making skills.
Methylphenidate: Adolescents will receive methylphenidate.
|
Total
n=158 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Past 90-day marijuana use
No Use
|
101 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
130 Participants
n=31 Participants
|
|
Past 90-day marijuana use
1-2 Times
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
|
Past 90-day marijuana use
3-5 Times
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
|
Age, Continuous
|
13.77 years
STANDARD_DEVIATION 1.38 • n=99 Participants
|
14.63 years
STANDARD_DEVIATION 1.31 • n=107 Participants
|
14.12 years
STANDARD_DEVIATION 1.17 • n=206 Participants
|
14.25 years
STANDARD_DEVIATION 1.44 • n=7 Participants
|
13.94 years
STANDARD_DEVIATION 1.38 • n=31 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
41 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
82 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
117 Participants
n=31 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
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 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
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
14 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
84 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
124 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
14 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
15 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
109 participants
n=99 Participants
|
16 participants
n=107 Participants
|
17 participants
n=206 Participants
|
16 participants
n=7 Participants
|
158 participants
n=31 Participants
|
|
Past 90-day alcohol use
No use
|
82 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
105 Participants
n=31 Participants
|
|
Past 90-day alcohol use
1-2 Times
|
18 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
35 Participants
n=31 Participants
|
|
Past 90-day alcohol use
3-5 Times
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
|
Past 90-day alcohol use
6-9 Times
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
9 Participants
n=31 Participants
|
|
Past 90-day alcohol use
10-19 Times
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
|
Past 90-day alcohol use
20-39 Times
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Past 90-day alcohol use
40 Times or More
|
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
|
|
Past 90-day marijuana use
6-9 Times
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
|
Past 90-day marijuana use
10-19 Times
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
|
Past 90-day marijuana use
20-39 Times
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
|
Past 90-day marijuana use
40 Times or More
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Assessed at 6 months after randomization to treatmentTeen self-report of substance use during the past 90 days
Outcome measures
| Measure |
Continued Monitoring and Assessment
n=16 Participants
All participants will receive 5 sessions of BEI. Non-responders will then be randomized to one of three conditions. Participants randomized to the continued monitoring and assessment arm will receive no additional intervention. Primary and secondary outcomes will be monitored.
Brief Early Intervention: Adolescents receive 5 individual sessions designed to strengthen the following skills: problem-solving, resisting peer pressure, and coping with emotions. Parents join portions of 3 sessions.
|
PT With ACBT
n=17 Participants
All participants will receive 5 sessions of BEI. Non-responders will then be randomized to one of three conditions. For participants randomized to the PT with ACBT arm, parents will participate in behavioral parent training (PT) and adolescents will participate in cognitive behavioral therapy to reduce substance use (CBT).
Brief Early Intervention: Adolescents receive 5 individual sessions designed to strengthen the following skills: problem-solving, resisting peer pressure, and coping with emotions. Parents join portions of 3 sessions.
Parent Training with Adolescent Cognitive Behavioral Therapy: Participants receive 12 family sessions with individual adolescent, parent, and joint adolescent and parent time. Includes additional parent training in behavioral modification, adolescent and parent contracting, and adolescent decision-making skills.
|
PT With ACBT and Methylphenidate
n=16 Participants
All participants will receive 5 sessions of BEI. Non-responders will then be randomized to one of three conditions. For participants randomized to the PT with ACBT and Methylphenidate arm, parents will participate in behavioral parent training (PT) and adolescents will participate in cognitive behavioral therapy to reduce substance use (ACBT). Adolescents will also receive methylphenidate.
Brief Early Intervention: Adolescents receive 5 individual sessions designed to strengthen the following skills: problem-solving, resisting peer pressure, and coping with emotions. Parents join portions of 3 sessions.
Parent Training with Adolescent Cognitive Behavioral Therapy: Participants receive 12 family sessions with individual adolescent, parent, and joint adolescent and parent time. Includes additional parent training in behavioral modification, adolescent and parent contracting, and adolescent decision-making skills.
Methylphenidate: Adolescents will receive methylphenidate.
|
|---|---|---|---|
|
Number of Participants With Past 90-day Alcohol Use
Missing data on this measure
|
6 Participants
|
13 Participants
|
8 Participants
|
|
Number of Participants With Past 90-day Alcohol Use
No alcohol use
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Past 90-day Alcohol Use
Used alcohol 1-2 times
|
2 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With Past 90-day Alcohol Use
Used alcohol 3-5 times
|
3 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Past 90-day Alcohol Use
Used alcohol 6-9 times
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Past 90-day Alcohol Use
Used alcohol 10-19 times
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Past 90-day Alcohol Use
Used alcohol 20-39 times
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Past 90-day Alcohol Use
Used alcohol 40 times or more
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Assessed at 6 months after randomization to treatmentUrine analysis indicates presence of illicit substance(s)
Outcome measures
| Measure |
Continued Monitoring and Assessment
n=16 Participants
All participants will receive 5 sessions of BEI. Non-responders will then be randomized to one of three conditions. Participants randomized to the continued monitoring and assessment arm will receive no additional intervention. Primary and secondary outcomes will be monitored.
Brief Early Intervention: Adolescents receive 5 individual sessions designed to strengthen the following skills: problem-solving, resisting peer pressure, and coping with emotions. Parents join portions of 3 sessions.
|
PT With ACBT
n=17 Participants
All participants will receive 5 sessions of BEI. Non-responders will then be randomized to one of three conditions. For participants randomized to the PT with ACBT arm, parents will participate in behavioral parent training (PT) and adolescents will participate in cognitive behavioral therapy to reduce substance use (CBT).
Brief Early Intervention: Adolescents receive 5 individual sessions designed to strengthen the following skills: problem-solving, resisting peer pressure, and coping with emotions. Parents join portions of 3 sessions.
Parent Training with Adolescent Cognitive Behavioral Therapy: Participants receive 12 family sessions with individual adolescent, parent, and joint adolescent and parent time. Includes additional parent training in behavioral modification, adolescent and parent contracting, and adolescent decision-making skills.
|
PT With ACBT and Methylphenidate
n=16 Participants
All participants will receive 5 sessions of BEI. Non-responders will then be randomized to one of three conditions. For participants randomized to the PT with ACBT and Methylphenidate arm, parents will participate in behavioral parent training (PT) and adolescents will participate in cognitive behavioral therapy to reduce substance use (ACBT). Adolescents will also receive methylphenidate.
Brief Early Intervention: Adolescents receive 5 individual sessions designed to strengthen the following skills: problem-solving, resisting peer pressure, and coping with emotions. Parents join portions of 3 sessions.
Parent Training with Adolescent Cognitive Behavioral Therapy: Participants receive 12 family sessions with individual adolescent, parent, and joint adolescent and parent time. Includes additional parent training in behavioral modification, adolescent and parent contracting, and adolescent decision-making skills.
Methylphenidate: Adolescents will receive methylphenidate.
|
|---|---|---|---|
|
Number of Participants With Evidence of Illicit Substances in Urine Screen
Positive for at least one substance
|
3 Participants
|
4 Participants
|
5 Participants
|
|
Number of Participants With Evidence of Illicit Substances in Urine Screen
Missing data on this measure
|
8 Participants
|
13 Participants
|
8 Participants
|
|
Number of Participants With Evidence of Illicit Substances in Urine Screen
Negative for all substances
|
5 Participants
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Assessed at 6 months after randomization to treatmentPopulation: Analysis population includes all participants with complete data on this measure at this time point.
Youth report of conflict with parents on the Conflict Behavior Questionnaire. Higher scores reflect higher parent teen conflict. Total score equals the average across item scores (ranging 1 to 5).
Outcome measures
| Measure |
Continued Monitoring and Assessment
n=6 Participants
All participants will receive 5 sessions of BEI. Non-responders will then be randomized to one of three conditions. Participants randomized to the continued monitoring and assessment arm will receive no additional intervention. Primary and secondary outcomes will be monitored.
Brief Early Intervention: Adolescents receive 5 individual sessions designed to strengthen the following skills: problem-solving, resisting peer pressure, and coping with emotions. Parents join portions of 3 sessions.
|
PT With ACBT
n=2 Participants
All participants will receive 5 sessions of BEI. Non-responders will then be randomized to one of three conditions. For participants randomized to the PT with ACBT arm, parents will participate in behavioral parent training (PT) and adolescents will participate in cognitive behavioral therapy to reduce substance use (CBT).
Brief Early Intervention: Adolescents receive 5 individual sessions designed to strengthen the following skills: problem-solving, resisting peer pressure, and coping with emotions. Parents join portions of 3 sessions.
Parent Training with Adolescent Cognitive Behavioral Therapy: Participants receive 12 family sessions with individual adolescent, parent, and joint adolescent and parent time. Includes additional parent training in behavioral modification, adolescent and parent contracting, and adolescent decision-making skills.
|
PT With ACBT and Methylphenidate
n=8 Participants
All participants will receive 5 sessions of BEI. Non-responders will then be randomized to one of three conditions. For participants randomized to the PT with ACBT and Methylphenidate arm, parents will participate in behavioral parent training (PT) and adolescents will participate in cognitive behavioral therapy to reduce substance use (ACBT). Adolescents will also receive methylphenidate.
Brief Early Intervention: Adolescents receive 5 individual sessions designed to strengthen the following skills: problem-solving, resisting peer pressure, and coping with emotions. Parents join portions of 3 sessions.
Parent Training with Adolescent Cognitive Behavioral Therapy: Participants receive 12 family sessions with individual adolescent, parent, and joint adolescent and parent time. Includes additional parent training in behavioral modification, adolescent and parent contracting, and adolescent decision-making skills.
Methylphenidate: Adolescents will receive methylphenidate.
|
|---|---|---|---|
|
Mean Youth-Report of Parent-adolescent Conflict
|
3.14 score on a scale
Standard Deviation 0.11
|
3.15 score on a scale
Standard Deviation 0
|
3.00 score on a scale
Standard Deviation 0.21
|
SECONDARY outcome
Timeframe: Assessed at 6 months after randomization to treatmentPopulation: Analysis population includes all participants with complete data on this measure.
Adolescent disruptive behaviors as measured by adolescent self-report and parent report on the Deviant Behavior Scale. Total scores on this measure reflect the average item rating across all items. Scores range from zero to 20 with higher scores reflecting self-report of engaging in more frequent deviant behaviors.
Outcome measures
| Measure |
Continued Monitoring and Assessment
n=10 Participants
All participants will receive 5 sessions of BEI. Non-responders will then be randomized to one of three conditions. Participants randomized to the continued monitoring and assessment arm will receive no additional intervention. Primary and secondary outcomes will be monitored.
Brief Early Intervention: Adolescents receive 5 individual sessions designed to strengthen the following skills: problem-solving, resisting peer pressure, and coping with emotions. Parents join portions of 3 sessions.
|
PT With ACBT
n=4 Participants
All participants will receive 5 sessions of BEI. Non-responders will then be randomized to one of three conditions. For participants randomized to the PT with ACBT arm, parents will participate in behavioral parent training (PT) and adolescents will participate in cognitive behavioral therapy to reduce substance use (CBT).
Brief Early Intervention: Adolescents receive 5 individual sessions designed to strengthen the following skills: problem-solving, resisting peer pressure, and coping with emotions. Parents join portions of 3 sessions.
Parent Training with Adolescent Cognitive Behavioral Therapy: Participants receive 12 family sessions with individual adolescent, parent, and joint adolescent and parent time. Includes additional parent training in behavioral modification, adolescent and parent contracting, and adolescent decision-making skills.
|
PT With ACBT and Methylphenidate
n=8 Participants
All participants will receive 5 sessions of BEI. Non-responders will then be randomized to one of three conditions. For participants randomized to the PT with ACBT and Methylphenidate arm, parents will participate in behavioral parent training (PT) and adolescents will participate in cognitive behavioral therapy to reduce substance use (ACBT). Adolescents will also receive methylphenidate.
Brief Early Intervention: Adolescents receive 5 individual sessions designed to strengthen the following skills: problem-solving, resisting peer pressure, and coping with emotions. Parents join portions of 3 sessions.
Parent Training with Adolescent Cognitive Behavioral Therapy: Participants receive 12 family sessions with individual adolescent, parent, and joint adolescent and parent time. Includes additional parent training in behavioral modification, adolescent and parent contracting, and adolescent decision-making skills.
Methylphenidate: Adolescents will receive methylphenidate.
|
|---|---|---|---|
|
Mean Youth Self-Report of Disruptive Behaviors
|
.090 score on a scale
Standard Deviation .166
|
.025 score on a scale
Standard Deviation .050
|
.100 score on a scale
Standard Deviation .185
|
SECONDARY outcome
Timeframe: Assessed at 6 months after randomization to treatmentPopulation: Analysis population includes all participants with complete data on this measure.
Youth self-report of likelihood of future substance use during the next year. Score reflects participant report of likelihood of using substances over the next year on a scale from 0 (Definitely will not use) to 10 (Definitely will use).
Outcome measures
| Measure |
Continued Monitoring and Assessment
n=10 Participants
All participants will receive 5 sessions of BEI. Non-responders will then be randomized to one of three conditions. Participants randomized to the continued monitoring and assessment arm will receive no additional intervention. Primary and secondary outcomes will be monitored.
Brief Early Intervention: Adolescents receive 5 individual sessions designed to strengthen the following skills: problem-solving, resisting peer pressure, and coping with emotions. Parents join portions of 3 sessions.
|
PT With ACBT
n=4 Participants
All participants will receive 5 sessions of BEI. Non-responders will then be randomized to one of three conditions. For participants randomized to the PT with ACBT arm, parents will participate in behavioral parent training (PT) and adolescents will participate in cognitive behavioral therapy to reduce substance use (CBT).
Brief Early Intervention: Adolescents receive 5 individual sessions designed to strengthen the following skills: problem-solving, resisting peer pressure, and coping with emotions. Parents join portions of 3 sessions.
Parent Training with Adolescent Cognitive Behavioral Therapy: Participants receive 12 family sessions with individual adolescent, parent, and joint adolescent and parent time. Includes additional parent training in behavioral modification, adolescent and parent contracting, and adolescent decision-making skills.
|
PT With ACBT and Methylphenidate
n=8 Participants
All participants will receive 5 sessions of BEI. Non-responders will then be randomized to one of three conditions. For participants randomized to the PT with ACBT and Methylphenidate arm, parents will participate in behavioral parent training (PT) and adolescents will participate in cognitive behavioral therapy to reduce substance use (ACBT). Adolescents will also receive methylphenidate.
Brief Early Intervention: Adolescents receive 5 individual sessions designed to strengthen the following skills: problem-solving, resisting peer pressure, and coping with emotions. Parents join portions of 3 sessions.
Parent Training with Adolescent Cognitive Behavioral Therapy: Participants receive 12 family sessions with individual adolescent, parent, and joint adolescent and parent time. Includes additional parent training in behavioral modification, adolescent and parent contracting, and adolescent decision-making skills.
Methylphenidate: Adolescents will receive methylphenidate.
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|---|---|---|---|
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Mean Youth Self-Report of Likelihood of Future Substance Use
|
5.14 score on a scale
Standard Deviation 2.73
|
4.33 score on a scale
Standard Deviation 3.06
|
6.00 score on a scale
Standard Deviation 1.00
|
SECONDARY outcome
Timeframe: Assessed at 6 months after randomization to treatmentPopulation: Analysis population includes all participants with complete data on this measure.
Level of impairment experienced across multiple domains of functioning (e.g., at school, at home, with peers) as measured by adolescent self-report on the Impairment Rating Scale. Total score is the mean item rating on a scale from 0 (No problem) to 6 (Extreme problem). Higher scores are indicative of greater impairment.
Outcome measures
| Measure |
Continued Monitoring and Assessment
n=10 Participants
All participants will receive 5 sessions of BEI. Non-responders will then be randomized to one of three conditions. Participants randomized to the continued monitoring and assessment arm will receive no additional intervention. Primary and secondary outcomes will be monitored.
Brief Early Intervention: Adolescents receive 5 individual sessions designed to strengthen the following skills: problem-solving, resisting peer pressure, and coping with emotions. Parents join portions of 3 sessions.
|
PT With ACBT
n=4 Participants
All participants will receive 5 sessions of BEI. Non-responders will then be randomized to one of three conditions. For participants randomized to the PT with ACBT arm, parents will participate in behavioral parent training (PT) and adolescents will participate in cognitive behavioral therapy to reduce substance use (CBT).
Brief Early Intervention: Adolescents receive 5 individual sessions designed to strengthen the following skills: problem-solving, resisting peer pressure, and coping with emotions. Parents join portions of 3 sessions.
Parent Training with Adolescent Cognitive Behavioral Therapy: Participants receive 12 family sessions with individual adolescent, parent, and joint adolescent and parent time. Includes additional parent training in behavioral modification, adolescent and parent contracting, and adolescent decision-making skills.
|
PT With ACBT and Methylphenidate
n=8 Participants
All participants will receive 5 sessions of BEI. Non-responders will then be randomized to one of three conditions. For participants randomized to the PT with ACBT and Methylphenidate arm, parents will participate in behavioral parent training (PT) and adolescents will participate in cognitive behavioral therapy to reduce substance use (ACBT). Adolescents will also receive methylphenidate.
Brief Early Intervention: Adolescents receive 5 individual sessions designed to strengthen the following skills: problem-solving, resisting peer pressure, and coping with emotions. Parents join portions of 3 sessions.
Parent Training with Adolescent Cognitive Behavioral Therapy: Participants receive 12 family sessions with individual adolescent, parent, and joint adolescent and parent time. Includes additional parent training in behavioral modification, adolescent and parent contracting, and adolescent decision-making skills.
Methylphenidate: Adolescents will receive methylphenidate.
|
|---|---|---|---|
|
Mean Youth Self-Report of Functional Impairment
|
1.43 score on a scale
Standard Deviation 1.15
|
1.6 score on a scale
Standard Deviation 1.74
|
1.91 score on a scale
Standard Deviation .83
|
Adverse Events
Continued Monitoring and Assessment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PT With ACBT
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
PT With ACBT and Methylphenidate
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
All Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Continued Monitoring and Assessment
n=16 participants at risk
All participants will receive 5 sessions of BEI. Non-responders will then be randomized to one of three conditions. Participants randomized to the continued monitoring and assessment arm will receive no additional intervention. Primary and secondary outcomes will be monitored.
Brief Early Intervention: Adolescents receive 5 individual sessions designed to strengthen the following skills: problem-solving, resisting peer pressure, and coping with emotions. Parents join portions of 3 sessions.
Adverse events for this group represent those report during Phase 2: Intervention Phase.
|
PT With ACBT
n=17 participants at risk
All participants will receive 5 sessions of BEI. Non-responders will then be randomized to one of three conditions. For participants randomized to the PT with ACBT arm, parents will participate in behavioral parent training (PT) and adolescents will participate in cognitive behavioral therapy to reduce substance use (CBT).
Brief Early Intervention: Adolescents receive 5 individual sessions designed to strengthen the following skills: problem-solving, resisting peer pressure, and coping with emotions. Parents join portions of 3 sessions.
Parent Training with Adolescent Cognitive Behavioral Therapy: Participants receive 12 family sessions with individual adolescent, parent, and joint adolescent and parent time. Includes additional parent training in behavioral modification, adolescent and parent contracting, and adolescent decision-making skills.
Adverse events for this group represent those report during Phase 2: Intervention Phase.
|
PT With ACBT and Methylphenidate
n=16 participants at risk
All participants will receive 5 sessions of BEI. Non-responders will then be randomized to one of three conditions. For participants randomized to the PT with ACBT and Methylphenidate arm, parents will participate in behavioral parent training (PT) and adolescents will participate in cognitive behavioral therapy to reduce substance use (ACBT). Adolescents will also receive methylphenidate.
Brief Early Intervention: Adolescents receive 5 individual sessions designed to strengthen the following skills: problem-solving, resisting peer pressure, and coping with emotions. Parents join portions of 3 sessions.
Parent Training with Adolescent Cognitive Behavioral Therapy: Participants receive 12 family sessions with individual adolescent, parent, and joint adolescent and parent time. Includes additional parent training in behavioral modification, adolescent and parent contracting, and adolescent decision-making skills.
Methylphenidate: Adolescents will receive methylphenidate.
Adverse events for this group represent those report during Phase 2: Intervention Phase.
|
All Participants
n=158 participants at risk
All participants for this study were initially assigned to receive the brief 5-session intervention. Six months following completion of that intervention, follow-up assessments took place to assess response to treatment.
Adverse events reported below reflect those reported for participants during Phase 1: Brief Intervention.
|
|---|---|---|---|---|
|
Psychiatric disorders
Admitted to in-patient psychiatric unit
|
0.00%
0/16 • Adverse event data were collected over the duration of participation in the study, which could be up to 24 months.
Participants were interviewed about potential adverse events at each follow-up assessment point. Additionally, participants were instructed to notify the investigators in the event of an adverse event between assessment points. Participants identified as "Responders (Never Randomized)" were never randomized to a treatment arm and are therefore not included in adverse event reporting.
|
5.9%
1/17 • Number of events 1 • Adverse event data were collected over the duration of participation in the study, which could be up to 24 months.
Participants were interviewed about potential adverse events at each follow-up assessment point. Additionally, participants were instructed to notify the investigators in the event of an adverse event between assessment points. Participants identified as "Responders (Never Randomized)" were never randomized to a treatment arm and are therefore not included in adverse event reporting.
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected over the duration of participation in the study, which could be up to 24 months.
Participants were interviewed about potential adverse events at each follow-up assessment point. Additionally, participants were instructed to notify the investigators in the event of an adverse event between assessment points. Participants identified as "Responders (Never Randomized)" were never randomized to a treatment arm and are therefore not included in adverse event reporting.
|
0.00%
0/158 • Adverse event data were collected over the duration of participation in the study, which could be up to 24 months.
Participants were interviewed about potential adverse events at each follow-up assessment point. Additionally, participants were instructed to notify the investigators in the event of an adverse event between assessment points. Participants identified as "Responders (Never Randomized)" were never randomized to a treatment arm and are therefore not included in adverse event reporting.
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. William E. Pelham Jr.
Florida International University
Phone: 305-348-3002
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place