Prevention of Adolescent Risky Behaviors: Neural Markers of Intervention Effects

NCT03370393 | Completed Results

• 2 other identifiers: 20173439R01DA040966
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

Brief Summary

Adolescence is a time of biological and behavioral changes that can lead to risky and dangerous behaviors, and African-American youth are highly vulnerable to the consequences of risky behavior, including HIV/AIDS and violence, leading to premature death. The investigators previously showed that an intervention program reduces HIV-risk vulnerability behaviors in many African-American youth. The investigators aim to measure how the program affects different regions of the brain in order to better prevent or reduce such risky behaviors among African-American youth.

Conditions

Risk-Taking; Adolescent Behavior

Keywords

Reward-drive; Cognitive-control

Outcome Measures

Primary Outcomes (1)

• Changes in Emotional Regulation

  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.

  18 weeks (from pre-intervention to 3-months after post-intervention)

Secondary Outcomes (1)

• Changes in Cognitive Regulation

  18 weeks (from pre-intervention to 3-months after post-intervention)

Study Arms (2)

Pathways for African-Americans' Success

EXPERIMENTAL

Subjects will complete a 6-week Pathways for African-Americans' Success (PAAS) intervention. This is a weekly, 1.5 hour/session, family intervention for 6 weeks.

Behavioral: Pathways for African-Americans' Success (PAAS)

Wait-list

NO INTERVENTION

Subjects will be on waiting list for active intervention and will receive the PAAS intervention at the end of the study (same as active intervention).

Interventions

Pathways for African-Americans' Success (PAAS) BEHAVIORAL

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.

Pathways for African-Americans' Success

Eligibility Criteria

• Age: 11 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Subject is of African-American racial status (self-reported)
• Subject can speak and read English
• Subject and parent/legal guardian agree to participate in the 6-week PAAS program
• Subject and parent/legal guardian agree to complete all assessments
• Subject must meet MRI safety eligibility

You may not qualify if:

• Subject has a major medical problem (e.g. neurological disorders)
• Subject is on medication(s) that affects the central nervous system
• Subject has behavioral/emotional problems at a clinical level (parent and/or youth report)
• Subject is pregnant or suspected of being pregnant (based on pregnancy test)
• Subject is color-blind
• Subject has claustrophobia
• Subject has metallic implants
• Subject drinks alcohol in the week prior to entry into the study (based on urine drug screen)
• Subject uses drugs in the week prior to entry into the study (based on urine drug screen)

Sponsors & Collaborators

• University of California, Irvine: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of California, Irvine

Irvine, California, 92617, United States

Location

MeSH Terms

Conditions

Risk-Taking; Adolescent Behavior

Condition Hierarchy (Ancestors)

Behavior

Limitations and Caveats

Trial was completed successfully.

Results Point of Contact

• Title: Dr. Uma Rao
• Organization: University of California, Irvine

umar@hs.uci.edu

949-824-8040

Study Officials

• Uma Rao, MD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The families will be randomized to Pathways for African Americans' Success (PAAS) intervention program or a wait-list condition (1:1 ratio) for 6 weeks. The wait-list group has the option to participate in the PAAS program at the end of the study.

Study Record Dates

• First Submitted: December 1, 2017
• First Posted: December 12, 2017
• Study Start: December 11, 2017
• Primary Completion: March 31, 2025
• Study Completion: April 10, 2025
• Last Updated: January 26, 2026
• Results First Posted: January 26, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)