Trial Outcomes & Findings for Prevention of Adolescent Risky Behaviors: Neural Markers of Intervention Effects (NCT NCT03370393)
NCT ID: NCT03370393
Last Updated: 2026-01-26
Results Overview
Emotional regulation was assessed through parent and youth self-reported questionnaires using the Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2). T scores, normed for age and sex are available. T-score standardizes an individual's executive functioning difficulties relative to peers. For example, 50 is the population mean and a standard deviation of 10. Higher scores indicate more significant problems. Scores below 60 are within normal limits; 60-64: subclinical difficulties; 65-69: mildly elevated; 70-74: moderately elevated; and 75 or above: considered highly elevated, suggesting significant difficulties in emotion regulation. These questionnaires were administered at baseline (before intervention) and 3 months post-intervention. Because parent report may be less biased regarding youth's regulation, we used parent data for analysis. Data imputation was done for missing data.
COMPLETED
NA
146 participants
18 weeks (from pre-intervention to 3-months after post-intervention)
2026-01-26
Participant Flow
Participant milestones
| Measure |
Pathways for African-Americans' Success
Subjects completed a 6-week Pathways for African-Americans' Success (PAAS) intervention. This is a weekly, 1.5 hour/session, family intervention for 6 weeks.
Pathways for African-Americans' Success (PAAS): PAAS is a 6-week, technology-delivered, family-based youth risk intervention program. PAAS includes 6 sessions for parents and youth, and joint sessions in which they both engage on the same computer to integrate and practice the skills they have just learned in their separate sessions. Each session includes a review, a virtual discussion, and observing and interacting with four parent and four youth Avatars that reflect phenotypes of African Americans (AA), with voice-overs by AA parents and youth. Videos portraying family interactions and intrapersonal processes are integrated into each session to convey key points of the intervention along with interactive activities to promote skill-building and to reinforce learning. PAAS also includes a technology tutorial and an introductory session.
|
Wait-list
Subjects were on a wait list for active intervention and received the PAAS intervention at the end of the study (same as active intervention).
|
|---|---|---|
|
Overall Study
STARTED
|
86
|
60
|
|
Overall Study
COMPLETED
|
71
|
50
|
|
Overall Study
NOT COMPLETED
|
15
|
10
|
Reasons for withdrawal
| Measure |
Pathways for African-Americans' Success
Subjects completed a 6-week Pathways for African-Americans' Success (PAAS) intervention. This is a weekly, 1.5 hour/session, family intervention for 6 weeks.
Pathways for African-Americans' Success (PAAS): PAAS is a 6-week, technology-delivered, family-based youth risk intervention program. PAAS includes 6 sessions for parents and youth, and joint sessions in which they both engage on the same computer to integrate and practice the skills they have just learned in their separate sessions. Each session includes a review, a virtual discussion, and observing and interacting with four parent and four youth Avatars that reflect phenotypes of African Americans (AA), with voice-overs by AA parents and youth. Videos portraying family interactions and intrapersonal processes are integrated into each session to convey key points of the intervention along with interactive activities to promote skill-building and to reinforce learning. PAAS also includes a technology tutorial and an introductory session.
|
Wait-list
Subjects were on a wait list for active intervention and received the PAAS intervention at the end of the study (same as active intervention).
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
15
|
10
|
Baseline Characteristics
Prevention of Adolescent Risky Behaviors: Neural Markers of Intervention Effects
Baseline characteristics by cohort
| Measure |
Pathways for African-Americans' Success
n=86 Participants
Subjects completed a 6-week Pathways for African-Americans' Success (PAAS) intervention. This is a weekly, 1.5 hour/session, family intervention for 6 weeks.
Pathways for African-Americans' Success (PAAS): PAAS is a 6-week, technology-delivered, family-based youth risk intervention program. PAAS includes 6 sessions for parents and youth, and joint sessions in which they both engage on the same computer to integrate and practice the skills they have just learned in their separate sessions. Each session includes a review, a virtual discussion, and observing and interacting with four parent and four youth Avatars that reflect phenotypes of African Americans (AA), with voice-overs by AA parents and youth. Videos portraying family interactions and intrapersonal processes are integrated into each session to convey key points of the intervention along with interactive activities to promote skill-building and to reinforce learning. PAAS also includes a technology tutorial and an introductory session.
|
Wait-list
n=60 Participants
Subjects were on a wait list for active intervention and received the PAAS intervention at the end of the study (same as active intervention).
|
Total
n=146 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
86 Participants
n=41 Participants
|
60 Participants
n=1581 Participants
|
146 Participants
n=4626 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Age, Continuous
|
12.56 Years
STANDARD_DEVIATION 1.0 • n=41 Participants
|
12.57 Years
STANDARD_DEVIATION 1.0 • n=1581 Participants
|
12.56 Years
STANDARD_DEVIATION 1.0 • n=4626 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=41 Participants
|
26 Participants
n=1581 Participants
|
64 Participants
n=4626 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=41 Participants
|
34 Participants
n=1581 Participants
|
82 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Black or African American
|
86 Participants
n=41 Participants
|
60 Participants
n=1581 Participants
|
146 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Region of Enrollment
United States
|
86 Participants
n=41 Participants
|
60 Participants
n=1581 Participants
|
146 Participants
n=4626 Participants
|
|
Emotion regulation
|
54.43 T score
STANDARD_DEVIATION 12.23 • n=41 Participants
|
52.02 T score
STANDARD_DEVIATION 10.15 • n=1581 Participants
|
53.44 T score
STANDARD_DEVIATION 11.45 • n=4626 Participants
|
PRIMARY outcome
Timeframe: 18 weeks (from pre-intervention to 3-months after post-intervention)Emotional regulation was assessed through parent and youth self-reported questionnaires using the Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2). T scores, normed for age and sex are available. T-score standardizes an individual's executive functioning difficulties relative to peers. For example, 50 is the population mean and a standard deviation of 10. Higher scores indicate more significant problems. Scores below 60 are within normal limits; 60-64: subclinical difficulties; 65-69: mildly elevated; 70-74: moderately elevated; and 75 or above: considered highly elevated, suggesting significant difficulties in emotion regulation. These questionnaires were administered at baseline (before intervention) and 3 months post-intervention. Because parent report may be less biased regarding youth's regulation, we used parent data for analysis. Data imputation was done for missing data.
Outcome measures
| Measure |
Pathways for African-Americans' Success
n=86 Participants
Subjects completed a 6-week Pathways for African-Americans' Success (PAAS) intervention. This is a weekly, 1.5 hour/session, family intervention for 6 weeks.
Pathways for African-Americans' Success (PAAS): PAAS is a 6-week, technology-delivered, family-based youth risk intervention program. PAAS includes 6 sessions for parents and youth, and joint sessions in which they both engage on the same computer to integrate and practice the skills they have just learned in their separate sessions. Each session includes a review, a virtual discussion, and observing and interacting with four parent and four youth Avatars that reflect phenotypes of African Americans (AA), with voice-overs by AA parents and youth. Videos portraying family interactions and intrapersonal processes are integrated into each session to convey key points of the intervention along with interactive activities to promote skill-building and to reinforce learning. PAAS also includes a technology tutorial and an introductory session.
|
Wait-list
n=60 Participants
Subjects were on waitlist for active intervention and were offered the PAAS intervention at the end of the study (same as active intervention).
|
|---|---|---|
|
Changes in Emotional Regulation
Pre-intervention (baseline)
|
54.43 T Score
Standard Deviation 12.23
|
52.02 T Score
Standard Deviation 10.15
|
|
Changes in Emotional Regulation
Post-intervention (3-month follow-up after 6-week intervention)
|
54.47 T Score
Standard Deviation 13.74
|
60.77 T Score
Standard Deviation 16.76
|
SECONDARY outcome
Timeframe: 18 weeks (from pre-intervention to 3-months after post-intervention)Population: One participant did not complete this section
Cognitive regulation was assessed through parent and youth self-reported questionnaires using the Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2). T scores, normed for age and sex are available. T-score standardizes an individual's executive functioning difficulties relative to peers. For example, 50 is the population mean and a standard deviation of 10. Higher scores indicate more significant problems. Scores below 60 are within normal limits; 60-64: subclinical difficulties; 65-69: mildly elevated; 70-74: moderately elevated; and 75 or above: considered highly elevated, suggesting significant difficulties in cognitive regulation. These questionnaires were administered at baseline (before intervention) and 3 months post-intervention. Because parent report may be less biased regarding youth's regulation, we used parent data for analysis. Data imputation was done for missing data.
Outcome measures
| Measure |
Pathways for African-Americans' Success
n=86 Participants
Subjects completed a 6-week Pathways for African-Americans' Success (PAAS) intervention. This is a weekly, 1.5 hour/session, family intervention for 6 weeks.
Pathways for African-Americans' Success (PAAS): PAAS is a 6-week, technology-delivered, family-based youth risk intervention program. PAAS includes 6 sessions for parents and youth, and joint sessions in which they both engage on the same computer to integrate and practice the skills they have just learned in their separate sessions. Each session includes a review, a virtual discussion, and observing and interacting with four parent and four youth Avatars that reflect phenotypes of African Americans (AA), with voice-overs by AA parents and youth. Videos portraying family interactions and intrapersonal processes are integrated into each session to convey key points of the intervention along with interactive activities to promote skill-building and to reinforce learning. PAAS also includes a technology tutorial and an introductory session.
|
Wait-list
n=59 Participants
Subjects were on waitlist for active intervention and were offered the PAAS intervention at the end of the study (same as active intervention).
|
|---|---|---|
|
Changes in Cognitive Regulation
Pre-intervention (baseline)
|
55.41 T Score
Standard Deviation 10.71
|
54.51 T Score
Standard Deviation 10.52
|
|
Changes in Cognitive Regulation
post-intervention (3-month follow-up after intervention)
|
51.81 T Score
Standard Deviation 20.94
|
55.66 T Score
Standard Deviation 18.44
|
Adverse Events
Pathways for African-Americans' Success
Wait-list
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