PAAS Intervention for Adolescent Risky Behaviors

Overseen By Adriana Pedroza, BA

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Irvine

Must not be taking: CNS medications

Disqualifiers: Neurological disorders, Pregnancy, Claustrophobia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

Duration: 6 weeks

146 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Uma Rao, MD

Principal Investigator

University of California, Irvine

Eligibility Criteria

This trial is for African-American adolescents who can speak and read English, are willing to participate in a 6-week program called PAAS with their guardian, and pass MRI safety checks. It's not for those who are pregnant, claustrophobic, have metal implants, used alcohol or drugs recently, have major medical issues like neurological disorders, take CNS-affecting meds or have clinical-level behavioral problems.

Inclusion Criteria

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

Exclusion Criteria

Subject has claustrophobia

I am taking medication that affects my brain or nerves.

Subject has a major medical problem (e.g. neurological disorders)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 6-week computer-interactive, family-based intervention

6 weeks

6 visits (in-person, weekly)

Follow-up

Participants are monitored for changes in cognitive and emotional regulation post-intervention

3 months

Assessments at baseline and 3 months post-intervention

Treatment Details

Interventions

• Pathways for African-Americans' Success (PAAS)

Trial Overview The study tests the PAAS intervention program designed to reduce risky behaviors among African-American youth. Researchers will look at how this program influences brain regions associated with risk-taking behavior by using MRI scans before and after the program.

Participant Groups

Group I: Pathways for African-Americans' Success Experimental Treatment 1 Intervention

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.

Group II: Wait-list Active Control 1 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).

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials

580

Recruited

4,943,000+