Clinical trial NCT05380765: 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
Overall status: RECRUITING
Phase: NA
Conditions: Alcohol Drinking
Tobacco Use
Drug Use
Lead sponsor: University of Rhode Island
Sponsor class: OTHER
First posted: 2022-05-19
Enrollment: 60
Sex: ALL
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: wait-list control
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Past month alcohol use
timeFrame: Baseline
measure: Past month alcohol use
timeFrame: End of treatment (up to 12 weeks following baseline)
measure: Past month alcohol use
timeFrame: Six months following end of treatment
measure: Past three-month alcohol use
timeFrame: Baseline
measure: Past three-month alcohol use
timeFrame: End of treatment (up to 12 weeks following baseline)
measure: Past three-month alcohol use
timeFrame: Six months following end of treatment
measure: Past month marijuana use
timeFrame: Baseline
measure: Past month marijuana use
timeFrame: End of treatment (up to 12 weeks following baseline)
measure: Past month marijuana use
timeFrame: Six months following end of treatment
measure: Past three-month marijuana use
timeFrame: Baseline
measure: Past three-month marijuana use
timeFrame: End of treatment (up to 12 weeks following baseline)
measure: Past three-month marijuana use
timeFrame: Six months following end of treatment
measure: Past month cigarette smoking
timeFrame: Baseline
measure: Past month cigarette smoking
timeFrame: End of treatment (up to 12 weeks following baseline)
measure: Past month cigarette smoking
timeFrame: Six months following end of treatment
measure: Past three-month cigarette smoking
timeFrame: Baseline
measure: Past three-month cigarette smoking
timeFrame: End of treatment (up to 12 weeks following baseline)
measure: Past three-month cigarette smoking
timeFrame: Six months following end of treatment
measure: Alcohol use intentions
timeFrame: Baseline
measure: Alcohol use intentions
timeFrame: End of treatment (up to 12 weeks following baseline)
measure: Alcohol use intentions
timeFrame: Six months following end of treatment
measure: Cigarette smoking susceptibility
timeFrame: Baseline
measure: Cigarette smoking susceptibility
timeFrame: End of treatment (up to 12 weeks following baseline)
measure: Cigarette smoking susceptibility
timeFrame: Six months following end of treatment
measure: Marijuana use intentions
timeFrame: Baseline
measure: Marijuana use intentions
timeFrame: End of treatment (up to 12 weeks following baseline)
measure: Marijuana use intentions
timeFrame: Six months following end of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Kingston
country: United States
facility: University of Rhode Island
state: Rhode Island
Study officials:
affiliation: University of Rhode Island
name: Nichea S Spillane, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: