Actively Recruiting

Phase Not Applicable
Age: 10Years - 14Years
All Genders
Healthy Volunteers
ID05380765

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

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are developing and testing Native PATHS, a culturally adapted prevention program designed to reduce substance use initiation among Indigenous youth in 5th to 8th grade. This program addresses alcohol, tobacco, and drug use, which start earlier and progress faster among Indigenous youth compared to other groups. The study aims to gather preliminary data on how acceptable, feasible, and initially effective Native PATHS is in this population. The study includes two stages: Stage 1a involves talking circles with youth and their family members to get feedback on the program's cultural fit and implementation. This is followed by an open pilot trial. In Stage 1b, 60 youth will be randomly assigned to either receive the Native PATHS program or be placed on a wait-list control group. The program uses a strengths-based, behavioral economic approach focusing on increasing engagement in activities that do not involve alcohol, tobacco, or other drugs, and reinforcing positive family rules and Indigenous parenting practices. Participants and their families will provide feedback after each session during the initial pilot phase. The study will measure past month and past three-month use of alcohol, marijuana, and cigarettes at baseline, at the end of treatment (up to 12 weeks), and six months post-treatment. Researchers will also assess intentions to use these substances and susceptibility to cigarette smoking. The total duration includes follow-up surveys at six months, with ongoing evaluation of the program's possible effects and mechanisms contributing to its impact.

CONDITIONS

Brief Title

Developing a Positive Approach to Substance Use Prevention in North American Indian Adolescents

Who Can Participate

Age: 10Years - 14Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Youth must reside in the First Nation community
  • Youth must identify as a member of a First Nation
  • Youth must be in 5th to 8th grade at enrollment
  • Only one youth per household may participate
  • Family members 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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - Up to 12 weeks following baseline

Participants engage in the Native PATHS program, a strengths-based, behavioral economic approach focused on increasing engagement and reinforcement for alternative activities to delay substance use initiation.

Weekly visits during the treatment period

Follow-up

Duration - 6 months following end of treatment

Participants complete follow-up assessments to evaluate substance use and intentions six months after the end of the treatment period.

1 to 2 visits depending on assessment schedule

Trial Site Locations

Total: 1 location

1

University of Rhode Island

Kingston, Rhode Island, United States, 02881-1967

Actively Recruiting

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Research Team

N

Nichea S Spillane, Ph.D.

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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