Developing a Positive Approach to Substance Use Prevention in North American Indian Adolescents
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 22, 2022
CompletedFirst Posted
Study publicly available on registry
May 19, 2022
CompletedStudy Start
First participant enrolled
June 17, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2025
CompletedJune 5, 2024
June 1, 2024
12 months
April 22, 2022
June 4, 2024
Conditions
Outcome Measures
Primary Outcomes (27)
Past month alcohol use
Respondents will be asked whether they have used alcohol in the past month (yes/no).
Baseline
Past month alcohol use
Respondents will be asked whether they have used alcohol in the past month (yes/no).
End of treatment (up to 12 weeks following baseline)
Past month alcohol use
Respondents will be asked whether they have used alcohol in the past month (yes/no).
Six months following end of treatment
Past three-month alcohol use
Respondents will be asked whether they have used alcohol in the past three months (yes/no).
Baseline
Past three-month alcohol use
Respondents will be asked whether they have used alcohol in the past three months (yes/no).
End of treatment (up to 12 weeks following baseline)
Past three-month alcohol use
Respondents will be asked whether they have used alcohol in the past three months (yes/no).
Six months following end of treatment
Past month marijuana use
Respondents will be asked whether they have used marijuana in the past month (yes/no).
Baseline
Past month marijuana use
Respondents will be asked whether they have used marijuana in the past month (yes/no).
End of treatment (up to 12 weeks following baseline)
Past month marijuana use
Respondents will be asked whether they have used marijuana in the past month (yes/no).
Six months following end of treatment
Past three-month marijuana use
Respondents will be asked whether they have used marijuana in the past three months (yes/no).
Baseline
Past three-month marijuana use
Respondents will be asked whether they have used marijuana in the past three months (yes/no).
End of treatment (up to 12 weeks following baseline)
Past three-month marijuana use
Respondents will be asked whether they have used marijuana in the past three months (yes/no).
Six months following end of treatment
Past month cigarette smoking
Respondents will be asked whether they have smoked cigarettes in the past month (yes/no).
Baseline
Past month cigarette smoking
Respondents will be asked whether they have smoked cigarettes in the past month (yes/no).
End of treatment (up to 12 weeks following baseline)
Past month cigarette smoking
Respondents will be asked whether they have smoked cigarettes in the past month (yes/no).
Six months following end of treatment
Past three-month cigarette smoking
Respondents will be asked whether they have smoked cigarettes in the past three months (yes/no).
Baseline
Past three-month cigarette smoking
Respondents will be asked whether they have smoked cigarettes in the past three months (yes/no).
End of treatment (up to 12 weeks following baseline)
Past three-month cigarette smoking
Respondents will be asked whether they have smoked cigarettes in the past three months (yes/no).
Six months following end of treatment
Alcohol use intentions
Respondent will be asked how often in the next month they think they will get drunk with friends and how often in the next month they would like to get drunk with friends, on a five-point scale from 0 (never) to 4 (10 or more times), where higher scores indicate more frequent intentions to use alcohol in the next month.
Baseline
Alcohol use intentions
Respondent will be asked how often in the next month they think they will get drunk with friends and how often in the next month they would like to get drunk with friends, on a five-point scale from 0 (never) to 4 (10 or more times), where higher scores indicate more frequent intentions to use alcohol in the next month.
End of treatment (up to 12 weeks following baseline)
Alcohol use intentions
Respondent will be asked how often in the next month they think they will get drunk with friends and how often in the next month they would like to get drunk with friends, on a five-point scale from 0 (never) to 4 (10 or more times), where higher scores indicate more frequent intentions to use alcohol in the next month.
Six months following end of treatment
Cigarette smoking susceptibility
Cigarette smoking intentions will be measured using the Susceptibility to Smoking measure, which includes four items that asking respondents the likelihood that they will begin to smoke/experiment with cigarettes on a four-point scale from 0 (definitely not) to 3 (definitely yes), with higher scores indicating greater likelihood of intending to smoke cigarettes in the future.
Baseline
Cigarette smoking susceptibility
Cigarette smoking intentions will be measured using the Susceptibility to Smoking measure, which includes four items that asking respondents the likelihood that they will begin to smoke/experiment with cigarettes on a four-point scale from 0 (definitely not) to 3 (definitely yes), with higher scores indicating greater likelihood of intending to smoke cigarettes in the future.
End of treatment (up to 12 weeks following baseline)
Cigarette smoking susceptibility
Cigarette smoking intentions will be measured using the Susceptibility to Smoking measure, which includes four items that asking respondents the likelihood that they will begin to smoke/experiment with cigarettes on a four-point scale from 0 (definitely not) to 3 (definitely yes), with higher scores indicating greater likelihood of intending to smoke cigarettes in the future.
Six months following end of treatment
Marijuana use intentions
Respondent will be asked how often in the next month they think they will use marijuana with friends and how often in the next month they would like to use marijuana with friends, on a five-point scale from 0 (never) to 4 (10 or more times), where higher scores indicate more frequent intentions to use marijuana in the next month.
Baseline
Marijuana use intentions
Respondent will be asked how often in the next month they think they will use marijuana with friends and how often in the next month they would like to use marijuana with friends, on a five-point scale from 0 (never) to 4 (10 or more times), where higher scores indicate more frequent intentions to use marijuana in the next month.
End of treatment (up to 12 weeks following baseline)
Marijuana use intentions
Respondent will be asked how often in the next month they think they will use marijuana with friends and how often in the next month they would like to use marijuana with friends, on a five-point scale from 0 (never) to 4 (10 or more times), where higher scores indicate more frequent intentions to use marijuana in the next month.
Six months following end of treatment
Study Arms (2)
Native PATHS Condition
EXPERIMENTALA strengths-based, behavioral economic approach to increasing engagement and reinforcement for engaging in alternative activities.
Wait-List Control
NO INTERVENTIONParticipants will receive the Native PATHS program once 6-month follow up surveys have been completed.
Interventions
A strengths-based, behavioral economic approach to increasing engagement and reinforcement for engaging in alternative activities.
Eligibility Criteria
You may qualify if:
- 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.
- at least 18 years of age
- reside within the First Nation community
- be identified, by the youth, as an important influence in their life
- be committed to helping the youth make good decisions regarding using substances
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Rhode Island
Kingston, Rhode Island, 02881-1967, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nichea S Spillane, Ph.D.
University of Rhode Island
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 22, 2022
First Posted
May 19, 2022
Study Start
June 17, 2024
Primary Completion
May 31, 2025
Study Completion
May 31, 2025
Last Updated
June 5, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will not share