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

Primary Purpose

Alcohol Drinking, Tobacco Use, Drug Use

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Native PATHS
Sponsored by
University of Rhode Island
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alcohol Drinking

Eligibility Criteria

10 Years - 14 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Rhode IslandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Native PATHS Condition

Wait-List Control

Arm Description

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

Participants will receive the Native PATHS program once 6-month follow up surveys have been completed.

Outcomes

Primary Outcome Measures

Past month alcohol use
Respondents will be asked whether they have used alcohol in the past month (yes/no).
Past month alcohol use
Respondents will be asked whether they have used alcohol in the past month (yes/no).
Past month alcohol use
Respondents will be asked whether they have used alcohol in the past month (yes/no).
Past three-month alcohol use
Respondents will be asked whether they have used alcohol in the past three months (yes/no).
Past three-month alcohol use
Respondents will be asked whether they have used alcohol in the past three months (yes/no).
Past three-month alcohol use
Respondents will be asked whether they have used alcohol in the past three months (yes/no).
Past month marijuana use
Respondents will be asked whether they have used marijuana in the past month (yes/no).
Past month marijuana use
Respondents will be asked whether they have used marijuana in the past month (yes/no).
Past month marijuana use
Respondents will be asked whether they have used marijuana in the past month (yes/no).
Past three-month marijuana use
Respondents will be asked whether they have used marijuana in the past three months (yes/no).
Past three-month marijuana use
Respondents will be asked whether they have used marijuana in the past three months (yes/no).
Past three-month marijuana use
Respondents will be asked whether they have used marijuana in the past three months (yes/no).
Past month cigarette smoking
Respondents will be asked whether they have smoked cigarettes in the past month (yes/no).
Past month cigarette smoking
Respondents will be asked whether they have smoked cigarettes in the past month (yes/no).
Past month cigarette smoking
Respondents will be asked whether they have smoked cigarettes in the past month (yes/no).
Past three-month cigarette smoking
Respondents will be asked whether they have smoked cigarettes in the past three months (yes/no).
Past three-month cigarette smoking
Respondents will be asked whether they have smoked cigarettes in the past three months (yes/no).
Past three-month cigarette smoking
Respondents will be asked whether they have smoked cigarettes in the past three months (yes/no).
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.
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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
April 22, 2022
Last Updated
September 26, 2023
Sponsor
University of Rhode Island
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1. Study Identification

Unique Protocol Identification Number
NCT05380765
Brief Title
Developing a Positive Approach to Substance Use Prevention in North American Indian Adolescents
Official Title
Developing a Positive Approach to Substance Use Prevention in North American Indian Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Rhode Island

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
Alcohol is one of the primary determinants of health disparity among many Indigenous populations with rates of alcohol-attributable mortality substantially higher than for Whites (73.8 per 100,000 vs. 27.5), and therefore, is a key threat to optimal health and well-being to Indigenous youth. Indigenous youth living in both the US and Canada tend to begin using alcohol, tobacco, and other drugs (ATOD) at earlier ages than most other ethnic/racial groups, and tend to move more quickly to regular use, resulting in earlier onset of ATOD disorders. Despite the severity of the problem, there continues to be an urgent unmet need for effective prevention programs that are culturally tailored to Indigenous populations of the US and Canada. The overall objective of this project is to develop and obtain preliminary data on the acceptability, feasibility, and initial efficacy of Native PATHS (Positive Approaches to reducing Harm from Substance Use). Native PATHS is a strengths-based, family prevention program for Indigenous youth in 5th-8th grade which focuses on delayed ATOD initiation. The development of Native PATHS has been guided by formative work in this community, taking a behavioral economic and positive psychological approach to prevention. Applied to prevention, behavioral economic theory focuses on reducing the availability of ATOD and increasing ATOD-free alternatives and the reinforcement received from engaging in ATOD-free activities. Activities in Native PATHS will work with families to help with establishing ATOD-free rules, limit physical availability of ATOD in the home, and reinforce youths' participation in ATOD-free activities. Positive psychological interventions (PPIs) focus on increasing positive emotions, life satisfaction, and well-being. PPIs will be used to enhance the enjoyment received from ATOD-free activities and to improve life satisfaction. Native PATHS is culturally consistent with North American Indigenous views of health that describe health in terms of a balance between the physical, spiritual, emotional, and mental aspects of life, which is represented in the teachings of the Medicine Wheel. Collaboratively, the investigators will work together with tribal partners on further adaptation of the program to include family and Indigenous ways of parenting in a culturally meaningful way. The overall goals proposed project will 1) finalize Native PATHS with participation from youth and family members in talking circles and an open pilot trial; 2) assess the effectiveness of Native PATHS in reducing ATOD initiation and intentions to use ATOD; 3) begin to evaluate the possible mechanisms/moderators of action including potential mediators future orientation and alternative reinforcer/activity engagement and reinforcement received, compared to a wait-list control group. The investigators will also evaluate positive affect as a potential moderator of any treatment effect, such that those higher in positive affect will be less likely to engage in ATOD use and be less likely to endorse intentions to use ATOD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Drinking, Tobacco Use, Drug Use

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
wait-list control
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Native PATHS Condition
Arm Type
Experimental
Arm Description
A strengths-based, behavioral economic approach to increasing engagement and reinforcement for engaging in alternative activities.
Arm Title
Wait-List Control
Arm Type
No Intervention
Arm Description
Participants will receive the Native PATHS program once 6-month follow up surveys have been completed.
Intervention Type
Behavioral
Intervention Name(s)
Native PATHS
Intervention Description
A strengths-based, behavioral economic approach to increasing engagement and reinforcement for engaging in alternative activities.
Primary Outcome Measure Information:
Title
Past month alcohol use
Description
Respondents will be asked whether they have used alcohol in the past month (yes/no).
Time Frame
Baseline
Title
Past month alcohol use
Description
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)
Title
Past month alcohol use
Description
Respondents will be asked whether they have used alcohol in the past month (yes/no).
Time Frame
Six months following end of treatment
Title
Past three-month alcohol use
Description
Respondents will be asked whether they have used alcohol in the past three months (yes/no).
Time Frame
Baseline
Title
Past three-month alcohol use
Description
Respondents will be asked whether they have used alcohol in the past three months (yes/no).
Time Frame
End of treatment (up to 12 weeks following baseline)
Title
Past three-month alcohol use
Description
Respondents will be asked whether they have used alcohol in the past three months (yes/no).
Time Frame
Six months following end of treatment
Title
Past month marijuana use
Description
Respondents will be asked whether they have used marijuana in the past month (yes/no).
Time Frame
Baseline
Title
Past month marijuana use
Description
Respondents will be asked whether they have used marijuana in the past month (yes/no).
Time Frame
End of treatment (up to 12 weeks following baseline)
Title
Past month marijuana use
Description
Respondents will be asked whether they have used marijuana in the past month (yes/no).
Time Frame
Six months following end of treatment
Title
Past three-month marijuana use
Description
Respondents will be asked whether they have used marijuana in the past three months (yes/no).
Time Frame
Baseline
Title
Past three-month marijuana use
Description
Respondents will be asked whether they have used marijuana in the past three months (yes/no).
Time Frame
End of treatment (up to 12 weeks following baseline)
Title
Past three-month marijuana use
Description
Respondents will be asked whether they have used marijuana in the past three months (yes/no).
Time Frame
Six months following end of treatment
Title
Past month cigarette smoking
Description
Respondents will be asked whether they have smoked cigarettes in the past month (yes/no).
Time Frame
Baseline
Title
Past month cigarette smoking
Description
Respondents will be asked whether they have smoked cigarettes in the past month (yes/no).
Time Frame
End of treatment (up to 12 weeks following baseline)
Title
Past month cigarette smoking
Description
Respondents will be asked whether they have smoked cigarettes in the past month (yes/no).
Time Frame
Six months following end of treatment
Title
Past three-month cigarette smoking
Description
Respondents will be asked whether they have smoked cigarettes in the past three months (yes/no).
Time Frame
Baseline
Title
Past three-month cigarette smoking
Description
Respondents will be asked whether they have smoked cigarettes in the past three months (yes/no).
Time Frame
End of treatment (up to 12 weeks following baseline)
Title
Past three-month cigarette smoking
Description
Respondents will be asked whether they have smoked cigarettes in the past three months (yes/no).
Time Frame
Six months following end of treatment
Title
Alcohol use intentions
Description
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.
Time Frame
Baseline
Title
Alcohol use intentions
Description
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.
Time Frame
End of treatment (up to 12 weeks following baseline)
Title
Alcohol use intentions
Description
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.
Time Frame
Six months following end of treatment
Title
Cigarette smoking susceptibility
Description
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.
Time Frame
Baseline
Title
Cigarette smoking susceptibility
Description
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.
Time Frame
End of treatment (up to 12 weeks following baseline)
Title
Cigarette smoking susceptibility
Description
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.
Time Frame
Six months following end of treatment
Title
Marijuana use intentions
Description
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.
Time Frame
Baseline
Title
Marijuana use intentions
Description
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.
Time Frame
End of treatment (up to 12 weeks following baseline)
Title
Marijuana use intentions
Description
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.
Time Frame
Six months following end of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria - Youth Participants: 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. Inclusion Criteria - Family Participants: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nichea S Spillane, Ph.D.
Phone
(401) 874-4252
Email
nspillane@uri.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nichea S Spillane, Ph.D.
Organizational Affiliation
University of Rhode Island
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rhode Island
City
Kingston
State/Province
Rhode Island
ZIP/Postal Code
02881-1967
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nichea S Spillane, Ph.D.
Phone
401-874-4252
Email
nspillane@uri.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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