Native PATHS Program for Substance Use Prevention in Indigenous Youth

Overseen By Nichea S Spillane, Ph.D.

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Rhode Island

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

60 Participants Needed

Trial Summary

What is the purpose of 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.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the Native PATHS treatment for substance use prevention in Indigenous youth?

Research shows that culturally adapted substance use prevention programs for Indigenous youth can reduce substance use frequency, improve knowledge and resistance strategies, and delay substance use initiation. Programs that involve community participation and cultural elements, like the Native PATHS, are particularly promising. ^{1 2 3 4 5}

What makes the Native PATHS treatment unique for preventing substance use in Indigenous youth?

The Native PATHS treatment is unique because it is culturally tailored specifically for Indigenous youth, incorporating cultural knowledge and community involvement, which are key elements that enhance its effectiveness compared to more generic prevention programs. ^{1 3 5 6 7}

Research Team

Nichea S Spillane, Ph.D.

Principal Investigator

University of Rhode Island

Eligibility Criteria

This trial is for North American Indian adolescents in grades 5th - 8th and their influential family members who are at least 18 years old. Participants should be living within a First Nation community and identify as a member of that community. Only one youth per household can join, with the goal to help them make good decisions about substance use.

Inclusion Criteria

Youth Participants must be residing in the First Nation community

I am committed to supporting a young person in making healthy choices about substance use.

Youth Participants must identify as a member of a First Nation

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Stage 1a - Talking Circles

Youth and family members participate in three talking circle sessions to provide feedback on cultural adaptation and implementation of the treatment.

4 weeks

3 visits (in-person)

Stage 1b - Pilot Randomized Controlled Trial

60 youth participate in a pilot randomized controlled trial to test the efficacy of the Native PATHS program against a wait-list control condition.

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, with surveys conducted to assess ATOD use and intentions.

6 months

Treatment Details

Interventions

• Native PATHS

Trial Overview The study is testing Native PATHS, an intervention aimed at preventing substance use among young people. It includes talking circles for feedback on cultural adaptation, an open label pilot for initial reactions, and finally a randomized controlled trial comparing the program's efficacy against waiting for treatment.

Participant Groups

Group I: Native PATHS Condition Experimental Treatment 1 Intervention

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

Group II: Wait-List Control Active Control 1 Intervention

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

Native PATHS is already approved in United States for the following indications:

Approved in United States as Native PATHS for:

• Substance use prevention in North American Indian adolescents

Who Is Running the Clinical Trial?

University of Rhode Island

Lead Sponsor

Trials

57

Recruited

22,400+

Findings from Research

Substance use prevention programs for Indigenous adolescents can effectively reduce substance use frequency and delay initiation, with key components including education, skills development, and cultural knowledge enhancement.

Programs developed in partnership with Indigenous communities showed the most promise, but the overall methodological quality of evaluations varied, highlighting the need for more rigorous studies to strengthen the evidence base.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preventing Substance Use Among Indigenous Adolescents in the USA, Canada, Australia and New Zealand: a Systematic Review of the Literature. Snijder, M., Stapinski, L., Lees, B., et al.[2022]

The Thiwáhe Gluwáš'akapi Program (TG) was culturally adapted for American Indian youth and showed significant improvements in key areas such as parental communication about substance use and youth resistance skills, indicating its potential effectiveness in preventing early substance use.

Both youth and adults reported positive changes in family dynamics and overall well-being, suggesting that the program not only addresses substance use prevention but also strengthens family relationships, which are crucial for supporting healthy development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Grounding evidence-based prevention within cultural context: promising effects of substance use prevention adapted for American Indian families. Asdigian, NL., Tuitt, N., Mousseau, AC., et al.[2023]

Substance abuse significantly impacts the health of American Indian and Alaska Native youth, highlighting the urgent need for effective prevention strategies.

Despite various intervention methods being implemented, there is a lack of empirical research evaluating their effectiveness, indicating a gap in understanding which programs work best for preventing substance use in Indian adolescents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preventing substance abuse in American Indian and Alaska native youth: promising strategies for healthier communities. Hawkins, EH., Cummins, LH., Marlatt, GA.[2007]

A study of Indigenous adolescents (ages 10-18) found that those who started using substances early (36.3% of participants) faced more psychosocial difficulties and negative outcomes compared to those who started later (25.3% of participants).

The research highlights the importance of timing in substance use onset, suggesting that prevention efforts should target children in late childhood and continue through mid-adolescence to reduce the risk of substance-related issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trajectories of Substance Use: Onset and Adverse Outcomes Among North American Indigenous Adolescents. Sittner, KJ.[2023]

Culturally tailored school-based substance use prevention programs for Indigenous youth, developed with input from Indigenous stakeholders, are more effective in changing knowledge, attitudes, and behaviors related to substance use.

The review emphasizes that integrating Indigenous beliefs, values, and worldviews into prevention curricula enhances the effectiveness and sustainability of these programs, highlighting the importance of community involvement in their development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A scoping review of school-based indigenous substance use prevention in preteens (7-13 years). Maina, G., Mclean, M., Mcharo, S., et al.[2021]

Indigenous adolescents face a higher risk of substance use issues, making prevention programs crucial for improving their health outcomes, but there is currently no conclusive evidence on the effectiveness of these programs specifically for this group.

This review aims to synthesize international evidence on substance use prevention programs for Indigenous adolescents, evaluating their effectiveness, delivery methods, and settings, to identify key elements that could inform future interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Substance Use Prevention Programs for Indigenous Adolescents in the United States of America, Canada, Australia and New Zealand: Protocol for a Systematic Review. Snijder, M., Stapinski, L., Lees, B., et al.[2020]

The Journeys of the Circle Project focuses on culturally appropriate substance prevention and intervention strategies specifically designed for American Indian and Alaska Native (AIAN) communities, addressing a critical need in schools and communities.

Previous interventions for reducing substance misuse in these communities have largely been unsuccessful, highlighting the importance of integrating historic cultural traditions into new prevention programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Journeys of the Circle: a culturally congruent life skills intervention for adolescent Indian drinking. Marlatt, GA., Larimer, ME., Mail, PD., et al.[2015]

References

1. United States pubmed.ncbi.nlm.nih.gov

Preventing Substance Use Among Indigenous Adolescents in the USA, Canada, Australia and New Zealand: a Systematic Review of the Literature. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Grounding evidence-based prevention within cultural context: promising effects of substance use prevention adapted for American Indian families. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Preventing substance abuse in American Indian and Alaska native youth: promising strategies for healthier communities. [2007]

4. United States pubmed.ncbi.nlm.nih.gov

Trajectories of Substance Use: Onset and Adverse Outcomes Among North American Indigenous Adolescents. [2023]

5. England pubmed.ncbi.nlm.nih.gov

A scoping review of school-based indigenous substance use prevention in preteens (7-13 years). [2021]

6. Canada pubmed.ncbi.nlm.nih.gov

Substance Use Prevention Programs for Indigenous Adolescents in the United States of America, Canada, Australia and New Zealand: Protocol for a Systematic Review. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Journeys of the Circle: a culturally congruent life skills intervention for adolescent Indian drinking. [2015]