Recruiting

Substance Use Prevention

Sponsor:

University of Rhode Island

Code:

NCT05380765

Conditions

Alcohol Drinking

Tobacco Use

Drug Use

Eligibility Criteria

Sex: All

Age: 10 - 14

Healthy Volunteers: Accepted

Interventions

Native PATHS

Study Details

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.

Conditions

Alcohol Drinking

Tobacco Use

Drug Use

Study ID

NCT05380765

Start date

Jun 17, 2024

Status verified date

Jun, 2024

Completion date

May 31, 2025

Anticipated

Primary completion date

May 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 14

Healthy Volunteers: Accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

Native PATHS

A strengths-based, behavioral economic approach to increasing engagement and reinforcement for engaging in alternative activities.

Primary outcome measure

  • Past month alcohol use [ Time Frame: Baseline ]
  • Past month alcohol use [ Time Frame: End of treatment (up to 12 weeks following baseline) ]
  • Past month alcohol use [ Time Frame: Six months following end of treatment ]
  • Past three-month alcohol use [ Time Frame: Baseline ]
  • Past three-month alcohol use [ Time Frame: End of treatment (up to 12 weeks following baseline) ]
  • Past three-month alcohol use [ Time Frame: Six months following end of treatment ]
  • Past month marijuana use [ Time Frame: Baseline ]
  • Past month marijuana use [ Time Frame: End of treatment (up to 12 weeks following baseline) ]
  • Past month marijuana use [ Time Frame: Six months following end of treatment ]
  • Past three-month marijuana use [ Time Frame: Baseline ]
  • Past three-month marijuana use [ Time Frame: End of treatment (up to 12 weeks following baseline) ]
  • Past three-month marijuana use [ Time Frame: Six months following end of treatment ]
  • Past month cigarette smoking [ Time Frame: Baseline ]
  • Past month cigarette smoking [ Time Frame: End of treatment (up to 12 weeks following baseline) ]
  • Past month cigarette smoking [ Time Frame: Six months following end of treatment ]
  • Past three-month cigarette smoking [ Time Frame: Baseline ]
  • Past three-month cigarette smoking [ Time Frame: End of treatment (up to 12 weeks following baseline) ]
  • Past three-month cigarette smoking [ Time Frame: Six months following end of treatment ]
  • Alcohol use intentions [ Time Frame: Baseline ]
  • Alcohol use intentions [ Time Frame: End of treatment (up to 12 weeks following baseline) ]
  • Alcohol use intentions [ Time Frame: Six months following end of treatment ]
  • Cigarette smoking susceptibility [ Time Frame: Baseline ]
  • Cigarette smoking susceptibility [ Time Frame: End of treatment (up to 12 weeks following baseline) ]
  • Cigarette smoking susceptibility [ Time Frame: Six months following end of treatment ]
  • Marijuana use intentions [ Time Frame: Baseline ]
  • Marijuana use intentions [ Time Frame: End of treatment (up to 12 weeks following baseline) ]
  • Marijuana use intentions [ Time Frame: Six months following end of treatment ]

Central Contacts and Locations

Central contacts

Nichea S Spillane, Ph.D.

(401) 874-4252nspillane@uri.edu

Locations

University of Rhode Island

Recruiting

Kingston, Rhode Island, United States, 02881-1967

Contacts

Nichea S Spillane, Ph.D.

401-874-4252nspillane@uri.edu

More Information

Sponsor

University of Rhode Island

Last update posted

Jun 5, 2024

Last verified

Jun, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Rhode Island on 2024-06-05.