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RECRUITING
NCT05380765
NA

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

Sponsor: University of Rhode Island

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

10 Years - 14 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2024-06-17

Completion Date

2025-05-31

Last Updated

2024-06-05

Healthy Volunteers

Yes

Interventions

BEHAVIORAL

Native PATHS

A strengths-based, behavioral economic approach to increasing engagement and reinforcement for engaging in alternative activities.

Locations (1)

University of Rhode Island

Kingston, Rhode Island, United States