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

NCT05380765 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-06-05

No results posted yet for this study

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.

Conditions

  • Alcohol Drinking
  • Tobacco Use
  • Drug Use

Interventions

BEHAVIORAL

Native PATHS

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

Sponsors & Collaborators

  • University of Rhode Island

    lead OTHER

Principal Investigators

  • Nichea S Spillane, Ph.D. · University of Rhode Island

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-17
Primary Completion
2025-05-31
Completion
2025-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05380765 on ClinicalTrials.gov