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Recruiting NCT05380765

Developing a Positive Approach to Substance Use Prevention in North American Indian Adolescents

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Trial Parameters

Condition Alcohol Drinking
Sponsor University of Rhode Island
Study Type INTERVENTIONAL
Phase N/A
Enrollment 60
Sex ALL
Min Age 10 Years
Max Age 14 Years
Start Date 2024-06-17
Completion 2025-05-31
Interventions
Native PATHS

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Brief Summary

The overall objective of this project is to develop and obtain preliminary data on acceptability, feasibility, and initial efficacy of Native PATHS. This work is guided by the stage model guidelines for treatment development and adaptation 25. Stage 1a will occur in two sequential steps. First, the investigators will recruit youth who are in 5th - 8th grade and their family members (N=24, 12 youth, 12 adults 18+) to participate in three talking circle sessions to obtain feedback on the cultural adaptation and implementation of the treatment. Next, the investigators will conduct an open label pilot (N=9). Youth and their family members, (up to 3 per youth) will provide qualitative and quantitative feedback after each session. In Stage 1b, 60 youth will participate in a pilot randomized controlled trial, testing the efficacy of the newly created program (n=30) against a wait list control (WLC) condition (n=30). Ultimately, this program of research is expected to result in a well-specified, efficacious prevention program that could be readily disseminated and generalizable to other Indigenous populations with minimal adaptation.

Eligibility Criteria

Inclusion Criteria - Youth Participants: 1. residing in the First Nation community, 2. identify as a member of a First Nation, 3. be in grades 5th - 8th at time of enrollment, and 4. one youth per household may participate. Inclusion Criteria - Family Participants: 1. at least 18 years of age 2. reside within the First Nation community 3. be identified, by the youth, as an important influence in their life 4. be committed to helping the youth make good decisions regarding using substances

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