Actively Recruiting
Developing a Positive Approach to Substance Use Prevention in North American Indian Adolescents
Led by University of Rhode Island · Updated on 2024-06-05
60
Participants Needed
1
Research Sites
49 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Developing a Positive Approach to Substance Use Prevention in North American Indian Adolescents
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Youth residing in the First Nation community
- Youth who identify as members of a First Nation
- Youth currently in grades 5th through 8th at enrollment
- Only one youth per household may participate
- Family participants must be at least 18 years old
- Family members must live within the First Nation community
- Family members must be identified by the youth as an important influence
- Family members must be committed to helping the youth make good decisions about substance use
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Rhode Island
Kingston, Rhode Island, United States, 02881-1967
Actively Recruiting
Research Team
N
Nichea S Spillane, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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