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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03370393
Other study ID # 20173439
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 11, 2017
Est. completion date March 31, 2025

Study information

Verified date February 2024
Source University of California, Irvine
Contact Anna Ter-Grigoryan, BS
Phone (949) 824-3770
Email tergriga@uci.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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.

Locations

Country Name City State
United States University of California, Irvine Irvine California

Sponsors (1)

Lead Sponsor Collaborator
University of California, Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in fronto-striatal functional connectivity Changes in fronto-striatal functional connectivity at rest and while performing a probabilistic reward task during an MRI scan from baseline to post-intervention 6 weeks
Secondary Changes in emotional regulation Emotional regulation will be assessed through parent and youth self-reported questionnaires, and summary scores will be derived from these questionnaires administered at baseline (before intervention) and 3 months post-intervention 3 months post-intervention
Secondary Changes in cognitive regulation Cognitive regulation will be assessed through parent and youth self-reported questionnaires, and summary scores will be derived from these questionnaires administered at baseline (before intervention) and 3 months post-intervention 3 months post-intervention
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