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

Disqualifiers: Non-First Nation, Grades 9+, others

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new program called Native PATHS, designed to prevent substance use among Indigenous youth. The research focuses on creating a culturally adapted program that promotes positive activities and behaviors. The trial will compare the program's effectiveness against a wait-list control group. Youth in grades 5-8 who live in a First Nation community and identify as a member of a First Nation, along with an influential adult from their household, are ideal candidates for this trial. As an unphased trial, participants can contribute to innovative research that could benefit their community.

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 prior data suggests that the Native PATHS program is safe for Indigenous youth?

Research shows that culturally sensitive prevention programs, like Native PATHS, may enhance the wellbeing of Indigenous youth by engaging them in positive and meaningful activities. Studies have found that similar programs focusing on land and culture can improve mental health and reduce the risk of substance use.

Although researchers are still testing the Native PATHS program, these findings suggest it could be well-received. The program emphasizes strengthening cultural identity and community support, which are generally safe approaches. Since this trial is in its early stages, researchers are primarily observing how participants respond to the program. Encouragingly, no negative effects have been reported from such programs so far. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Native PATHS program because it takes a unique strengths-based, behavioral economic approach to preventing substance use among Indigenous youth. Unlike traditional methods that might focus on abstinence or punishment, this program emphasizes increasing engagement in positive, alternative activities. By reinforcing these healthy behaviors, the program aims to build resilience and offer young people rewarding and constructive paths that naturally reduce the appeal of substance use. This innovative angle is what sets it apart from other prevention strategies.

What evidence suggests that the Native PATHS program is effective for substance use prevention in Indigenous youth?

Research has shown that the Native PATHS program, which participants in this trial may receive, is being developed to help prevent substance use among Indigenous youth. The program focuses on building positive behaviors and encouraging participation in alternative activities. Early results suggest this method could effectively engage young people and reduce substance use. Although solid data is not yet available because the program is still under study, emphasizing cultural adaptation and community involvement has proven important in similar prevention programs. ^{1 6 7 8 9}

Who Is on the Research Team?

Nichea S Spillane, Ph.D.

Principal Investigator

University of Rhode Island

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

Citations

1. reporter.nih.gov reporter.nih.gov/project-details/10912893

Examination of expanded impacts on youth and parents National Institute on Drug Abuse. Assistance Listing Number. 93.279. DUNS Number. 041096314. UEI. MW8JHK6ZYEX8. Project Start Date. 01-April-2019. Project End ...

2. withpower.com withpower.com/trial/early-phase-1-tobacco-use-8-2022-d3097

Native PATHS Program for Substance Use Prevention in ... The overall objective of this project is to develop and obtain preliminary data on acceptability, feasibility, and initial efficacy of Native PATHS.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05380765

Developing a Positive Approach to Substance Use ... The overall objective of this project is to develop and obtain preliminary data on acceptability, feasibility, and initial efficacy of Native PATHS.

4. coloradosph.cuanschutz.edu coloradosph.cuanschutz.edu/docs/librariesprovider205/journal_files/vol31/31_1_2024_50_hunter.pdf?sfvrsn=64afd8bb_1

AIANMHR, Vol. 31, Issue No. 1, 2024 - Hunter et al. According to the National Institute of Drug Abuse survey from 2009-2012, lifetime prevalence for disordered use of alcohol is 39%, marijuana is ...

5. reporter.nih.gov reporter.nih.gov/search/jXrdsl-f8Ea15gSyVPPguQ/project-details/10912893

RePORT RePORTER - National Institutes of Health (NIH) | Evaluation of an optimized intervention to prevent early substance use among American Indian youth: Examination of expanded impacts on youth and parents.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9489542/

Cultural Protection from Polysubstance Use Among Native ... Reservation-based Native American youth are at disproportionate risk for high-risk substance use. The culture-as-treatment hypothesis ...

7. umt.edu umt.edu/american-indian-governance-policy-institute/aigpi-landbased-programs-policy-report.pdf

Land-based Cultural Practices Show Promise for ... Research on these programs is growing, and they are showing promising outcomes for Indigenous youth wellbeing, including mental health and ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0272735822001180

Culturally sensitive prevention programs for substance use ... Data based on the 2015 to 2019 National Surveys on Drug Use and Health indicated that Native American and multiracial adolescents had higher rates of past-year ...

9. legacy.nihb.org legacy.nihb.org/aces-resource-basket/

Understanding ACEs in Indigenous Communities Preventing ACEs in Indigenous communities involves promoting positive childhood experiences and supporting Indigenous children and families ...