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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-14
SponsorUniversity of Rhode Island

About this trial

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

This trial accepts healthy volunteers

Qualifiers

residing in the First Nation community,

identify as a member of a First Nation,

be in grades 5th - 8th at time of enrollment, and

one youth per household may participate.

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Native PATHS

    Behavioral

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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Native PATHS ConditionExperimental treatment 1 intervention
Group B: Wait-List ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Past month alcohol use

Respondents will be asked whether they have used alcohol in the past month (yes/no).

Time frame
Baseline
2

Past month alcohol use

Respondents will be asked whether they have used alcohol in the past month (yes/no).

Time frame
End of treatment (up to 12 weeks following baseline)
3

Past month alcohol use

Respondents will be asked whether they have used alcohol in the past month (yes/no).

Time frame
Six months following end of treatment
4

Past three-month alcohol use

Respondents will be asked whether they have used alcohol in the past three months (yes/no).

Time frame
Baseline

Secondary outcomes

Other outcomes

Sponsors and contacts

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