Native PATHS Program for Substance Use Prevention in Indigenous Youth

Recruiting in Palo Alto (17 mi)

Overseen by Nichea S Spillane, Ph.D.

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Rhode Island

No Placebo Group

Approved in 1 Jurisdiction

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}

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.

I am at least 18 years old.

Trial 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 (Behavioral Intervention)

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Rhode Island Kingston, RI

Who Is Running the Clinical Trial?

University of Rhode Island Lead Sponsor

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] This systematic review assessed the current evidence base of substance use prevention programs for Indigenous adolescents in the USA, Canada, Australia and New Zealand. The authors investigated (a) the outcomes, type, setting and context of prevention programs; (b) the common components of beneficial prevention programs; and (c) the methodological quality of evaluations of included prevention programs. The authors searched eight peer-reviewed and 20 grey literature databases for studies published between 1 January 1990 and 31 August 2017. Data extracted included type of program (culturally adapted, culture-based or unadapted), the setting (school, community, family or multi-setting), delivery (computerised or traditional), context (Indigenous-specific or multi-cultural environment) and common components of the programs. Program evaluation methodologies were critically appraised against standardised criteria. This review identified 26 eligible studies. Substance use prevention programs for Indigenous youth led to reductions in substance use frequency and intention to use; improvements in substance-related knowledge, attitudes and resistance strategies; and delay in substance use initiation. Key elements of beneficial programs included substance use education, skills development, cultural knowledge enhancement and community involvement in program development. Five programs were rated as methodologically strong, seven were moderate and fourteen were weak. Prevention programs have the potential to reduce substance use among Indigenous adolescents, especially when they are developed in partnership with Indigenous people. However, more rigorously conducted evaluation trials are required to strengthen the evidence base.

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] Background: Effective substance use prevention strategies are needed for American Indian (AI) youth, who face disproportionate risk for early substance use and consequently bear a disproportionate burden of health and developmental disparities related to early use. With few exceptions, significant advances in prevention science have largely excluded this population, leaving gaps in the evidence of effective practice. This paper builds on emerging efforts to address this gap, reporting first outcome findings from an evidence-based early substance use prevention program culturally adapted for young adolescents on a Northern Plains reservation. Methods: Using a community-based participatory approach, the Thiw&#225;he Gluw&#225;&#353;'akapi Program (TG, sacred home in which family is made strong) was developed by embedding cultural kinship teachings within the Strengthening Families Program for Parents and Youth 10-14 and aligning other elements of program content with local culture and context. Results: Results of pre and post comparisons of proximal program outcomes showed that youth reported significant improvements in parental communication about substance use, substance use resistance skills, stress management, family cohesion, and overall well-being. Adults reported improvements in a wide array of parenting behaviors and indicators of family dynamics. Conclusions: These findings provide an initial glimpse into the potential effects of the TG program and suggest that it holds promise for helping AI families address risks for youth substance use through positive impacts on modifiable risk and protective factors documented to influence early substance use.

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

Preventing substance abuse in American Indian and Alaska native youth: promising strategies for healthier communities. [2007] Substance abuse has had profoundly devastating effects on the health and well-being of American Indians and Alaska Natives. A wide variety of intervention methods has been used to prevent or stem the development of alcohol and drug problems in Indian youth, but there is little empirical research evaluating these efforts. This article is an overview of the published literature on substance use prevention among Indian adolescents, providing background epidemiological information, a review of programs developed specifically for Indian adolescents, and recommendations for the most promising prevention strategies currently in practice.

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

Trajectories of Substance Use: Onset and Adverse Outcomes Among North American Indigenous Adolescents. [2023] North American Indigenous communities experience disproportionately high rates of substance use, abuse, and dependence and their accompanying consequences. This study uses group-based trajectory modeling of past-year substance use (alcohol, marijuana, and cigarettes) with a longitudinal sample of Indigenous adolescents from the northern Midwest and Canada (spanning ages 10-18 years). The early-onset trajectory (36.3%) had more adverse psychosocial difficulties at baseline than the mid-onset group (38.3%); both trajectories were associated with several negative outcomes at the end of the study. The late-onset trajectory (25.3%) did not initiate substance use until later adolescence and had far better outcomes at the last wave of the study. Timing of onset matters. Prevention efforts should begin in late childhood and continue through mid-adolescence.

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

A scoping review of school-based indigenous substance use prevention in preteens (7-13 years). [2021] Early-onset substance use is a risk factor for continued use, dependency, and poor long-term health outcomes. Indigenous youth are more likely to engage in early-onset substance use than their non-Indigenous counterparts. In Canada, culturally appropriate prevention programs are needed for Indigenous youth in elementary schools. Therefore, this scoping review aims to explore the published, international literature examining school-based substance use prevention programs for Indigenous children aged 7-13.

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] Indigenous adolescents are at a higher risk of experiencing harms related to substance use compared with their non-Indigenous counterparts as a consequence of earlier onset and higher rates of substance use. Early onset of substance use has been identified as a risk factor for future substance use problems and other health, social, and family outcomes. Therefore, prevention of substance use among adolescents has been identified as a key area to improve health of Indigenous Peoples. Evidence exists for the effectiveness of prevention approaches for adolescents in mainstream populations and, most recently, for the use of computer- and Internet-delivered interventions to overcome barriers to implementation. However, there is currently no conclusive evidence about the effectiveness of these approaches for Indigenous adolescents.

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

Journeys of the Circle: a culturally congruent life skills intervention for adolescent Indian drinking. [2015] There has been an increasing call for and development of culturally appropriate substance prevention/intervention for ethnic minorities in schools and communities, especially among reservation and in urban American Indian and Alaska Native (AIAN) communities. Past attempts to intervene in and reduce misuse of alcohol and other drugs have not had great success. The Journeys of the Circle Project utilized innovative programs with a strong emphasis on historic cultural traditions.