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

Status unconfirmed · Not applicable

Conditions studied: Alcohol Drinking, Tobacco Use, Drug Use

In brief

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.

Key facts

Study ID
NCT05380765
Run by
University of Rhode Island
People needed
60
Starts
2024-06-17
Expected to finish
2025-05-31
Last updated by the study team
2024-06-05

Who can join

Age: 10 and older, up to 14. Sex: any. Healthy volunteers: accepted.

Where it is running

Full record on ClinicalTrials.gov

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