Native PATHS for Alcohol Drinking

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Rhode Island, Kingston, RI
Alcohol Drinking+3 More
Native PATHS - Behavioral
Eligibility
< 18
All Sexes
What conditions do you have?
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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.

Eligible Conditions

  • Alcohol Drinking
  • Drug Use
  • Tobacco Use

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

9 Primary · 0 Secondary · Reporting Duration: Six months following end of treatment

Six months following end of treatment
Alcohol use intentions
Cigarette smoking susceptibility
Marijuana use intentions
Past month alcohol use
Past month cigarette smoking
Past month marijuana use
Past three-month alcohol use
Past three-month cigarette smoking
Past three-month marijuana use

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Wait-List Control
1 of 2
Native PATHS Condition
1 of 2
Active Control
Experimental Treatment

60 Total Participants · 2 Treatment Groups

Primary Treatment: Native PATHS · No Placebo Group · Phase < 1

Native PATHS Condition
Behavioral
Experimental Group · 1 Intervention: Native PATHS · Intervention Types: Behavioral
Wait-List ControlNoIntervention Group · 1 Intervention: Wait-List Control · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: six months following end of treatment
Closest Location: University of Rhode Island · Kingston, RI
Photo of rhode island 1Photo of rhode island 2Photo of rhode island 3
2011First Recorded Clinical Trial
1 TrialsResearching Alcohol Drinking
12 CompletedClinical Trials

Who is running the clinical trial?

University of Rhode IslandLead Sponsor
45 Previous Clinical Trials
21,161 Total Patients Enrolled
3 Trials studying Alcohol Drinking
279 Patients Enrolled for Alcohol Drinking
Nichea S Spillane, Ph.D.Principal InvestigatorUniversity of Rhode Island
1 Previous Clinical Trials
60 Total Patients Enrolled
1 Trials studying Alcohol Drinking
60 Patients Enrolled for Alcohol Drinking

Eligibility Criteria

Age < 18 · All Participants · 8 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are in grades 5th - 8th at time of enrollment.
You are at least 18 years old.
You are committed to helping the youth make good decisions regarding using substance.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.