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

Part of paid clinical trials in Kingston, Rhode Island.

Sponsor
University of Rhode Island
Study ID
NCT05380765
Status
Recruiting
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Conditions

  • Alcohol Drinking
  • Drug Use
  • Tobacco Use

Eligibility Criteria

Sex
ALL
Age
10 Years - 14 Years
Healthy Volunteers
Accepted

Interventions

  • Native PATHS — BEHAVIORAL
    A strengths-based, behavioral economic approach to increasing engagement and reinforcement for engaging in alternative activities.

Study Details

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 Dates

Start date
Jun 17, 2024
Status verified
Jun 2024
Primary completion
May 31, 2025
Completion
May 31, 2025

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Native PATHS Condition
    A strengths-based, behavioral economic approach to increasing engagement and reinforcement for engaging in alternative activities.
  • No Intervention: Wait-List Control
    Participants will receive the Native PATHS program once 6-month follow up surveys have been completed.

Primary Outcome Measure

Past month alcohol use [ Time Frame: Baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Rhode IslandKingstonRhode Island02881-1967
Nichea S Spillane, Ph.D.
[email protected]
401-874-4252

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