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NCT05380765 · ClinicalTrials.gov registry record · NA
Developing a Positive Approach to Substance Use Prevention in North American Indian Adolescents
A NA study of Alcohol Drinking and Tobacco Use, sponsored by University of Rhode Island.
- Recruiting
- Registry status
- NA
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT05380765 is a NA study of Alcohol Drinking and Tobacco Use that is actively recruiting participants, run by University of Rhode Island. The registered enrollment target is 60 participants, below the 630-participant average among 85 other Alcohol Drinking trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05380765, a NA study of Alcohol Drinking and Tobacco Use, is actively recruiting participants, sponsored by University of Rhode Island.
- RECRUITING
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
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 Studied
Interventions
- BEHAVIORAL Native PATHS
Study Locations (1)
Rhode Island
- University of Rhode Island - Kingston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2024-06-17 |
| Est. Completion | 2025-05-31 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05380765
The ClinicalTrials.gov registry entry for NCT05380765 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 630-participant average among 85 other Alcohol Drinking trials with a reported enrollment target (90% lower). The listed sponsor is University of Rhode Island, which has 29 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Alcohol Drinking appearing as the primary indexed condition, and to 1 intervention - of which Native PATHS is the first listed.
NCT05380765 reports 1 study location spanning 1 distinct geographic area - top geographies include Rhode Island.
Frequently Asked Questions
What is clinical trial NCT05380765 about?
NCT05380765 is a clinical study titled "Developing a Positive Approach to Substance Use Prevention in North American Indian Adolescents". 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 ...
What is the current status of trial NCT05380765?
This trial is currently recruiting. It is a NA study. The enrollment target is 60 participants. The study started on 2024-06-17. Estimated completion is 2025-05-31.
What conditions does trial NCT05380765 study?
This clinical trial studies the following conditions: Alcohol Drinking, Tobacco Use, Drug Use.
What interventions are being tested in trial NCT05380765?
The interventions under investigation include: Native PATHS (BEHAVIORAL).
Who is sponsoring clinical trial NCT05380765?
This trial is sponsored by University of Rhode Island, which has 29 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05380765 being conducted?
This trial has 1 study location across Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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