NCT05380765 Developing a Positive Approach to Substance Use Prevention in North American Indian Adolescents
| NCT ID | NCT05380765 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Rhode Island |
| Condition | Alcohol Drinking |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-06-17 |
| Primary Completion | 2025-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2024-06-17 with a primary completion date of 2025-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria - Youth Participants: 1. residing in the First Nation community, 2. identify as a member of a First Nation, 3. be in grades 5th - 8th at time of enrollment, and 4. one youth per household may participate. Inclusion Criteria - Family Participants: 1. at least 18 years of age 2. reside within the First Nation community 3. be identified, by the youth, as an important influence in their life 4. be committed to helping the youth make good decisions regarding using substances
Contact & Investigator
Nichea S Spillane, Ph.D.
PRINCIPAL INVESTIGATOR
University of Rhode Island
Frequently Asked Questions
Who can join the NCT05380765 clinical trial?
This trial is open to participants of all sexes, aged 10 Years or older, up to 14 Years, studying Alcohol Drinking. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05380765 currently recruiting?
Yes, NCT05380765 is actively recruiting participants. Contact the research team at nspillane@uri.edu for enrollment information.
Where is the NCT05380765 trial being conducted?
This trial is being conducted at Kingston, United States.
Who is sponsoring the NCT05380765 clinical trial?
NCT05380765 is sponsored by University of Rhode Island. The principal investigator is Nichea S Spillane, Ph.D. at University of Rhode Island. The trial plans to enroll 60 participants.