Thiwáhe Gluwáš'akapi for Substance Abuse Prevention

Overseen By Nancy Asdigian, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Prisoners, Decisionally-challenged adults

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

Compensation: Varies

Number of Visits: 2

Duration: 7 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program designed to prevent substance abuse and reduce suicide risk among young adolescents, particularly within American Indian families. The program, Thiwáhe Gluwáš'akapi, includes family sessions that aim to strengthen family bonds and encourage positive changes. It also examines whether these sessions can help adults reduce their substance use. Families living on a Northern Plains reservation, with children aged 10-12 attending school there, might be a good fit for this trial. As an unphased trial, this study offers families the opportunity to contribute to important research that could lead to meaningful community benefits.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Thiwáhe Gluwáš'akapi and Woyute Waśte programs are safe?

Research has shown that the Thiwáhe Gluwáš'akapi program, designed for American Indian families, impacts substance use in both youth and adults and addresses youth suicide risk. These studies have not reported any specific safety concerns.

Participants find the program a good fit for their community and easy to follow, indicating it is well-received. As this program is not a drug or medical treatment, it likely lacks the side effects associated with medications.

The program strengthens family connections and encourages healthy habits while respecting cultural traditions, which participants find positive and engaging. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Thiwáhe Gluwáš'akapi for substance abuse prevention because it combines family engagement with cultural values, offering a holistic approach that traditional treatments like individual counseling or medication might not provide. This program includes weekly in-person sessions that involve not just the individual, but their entire family, fostering a supportive community environment. The focus on both youth and adults in separate and joint sessions encourages comprehensive healing and understanding, which could lead to more sustainable outcomes in preventing substance abuse.

What evidence suggests that this trial's treatments could be effective for reducing substance use and suicide risk among youth and substance abuse among adults?

Research has shown that the Thiwáhe Gluwáš'akapi (TG) program, one of the treatments in this trial, is designed for American Indian families and may help reduce substance use among young teens. Early results suggest that the program could lower the risk of suicide among youth, a major concern for the communities involved. Additionally, evidence indicates that adults participating in the TG program with their children might improve their own substance use habits. The program is culturally adapted to strengthen family connections, which may lead to these positive effects. This approach emphasizes the importance of creating community-specific solutions to tackle substance use and related issues. Meanwhile, the Woyute Waśte program, another treatment arm in this trial, focuses on healthy eating and exercise, offering a valuable comparison condition for participants. ^{1 2 6 7 8}

Who Is on the Research Team?

Nancy R Whitesell, PhD

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

This trial is for American Indian families on a Northern Plains reservation, specifically adults over 18 who have a parenting role and children aged 10-12 attending school on the reservation. Both must enroll together, with the adult being a parent, grandparent, guardian or household member.

Inclusion Criteria

I am a key caregiver for the child in the study.

You are currently a student living on the reservation.

You must be participating in the study with a child who meets the eligibility criteria.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive the Thiwáhe Gluwáš'akapi (TG) substance use prevention program or the Woyute Waśte (WW) healthy eating and exercise program over 7 weeks

7 weeks

Weekly in-person 2.5 hour family sessions

Post-intervention

Post-intervention surveys are conducted 1 week after the last session to assess immediate outcomes

1 week

In-person survey administration

Follow-up

Participants are monitored for long-term outcomes with surveys conducted at 6-month intervals for 36 months

36 months

Surveys conducted online or in-person

What Are the Treatments Tested in This Trial?

Interventions

• Thiwáhe Gluwáš'akapi
• Woyute Waśte

Trial Overview The study tests Thiwáhe Gluwáš'akapi (TG), an adapted substance use prevention program. It aims to delay substance use in adolescents and reduce suicide risk among youth. The program's influence on adult substance abuse will also be evaluated.

How Is the Trial Designed?

Group I: Thiwáhe Gluwáš'akapi Experimental Treatment 1 Intervention

Weeks 1-7: Weekly in-person 2.5 hour family sessions 30 minute family meal 1 hour separate youth and adult sessions 1 hour family session

Group II: Woyute Waśte Active Control 1 Intervention

Respect for community and cultural values regarding research protocols precluded use of a randomized controlled design with a control group receiving no intervention, so we identified a cost-effective comparison condition program to offer value to study participants. A focus on healthy eating and exercise was of interest to community partners and not expected to directly confound the primary outcomes of the TG program (substance use and suicide risk). Week 1 in-person 2.5 hour family session 30 minute family meal 2 hour interactive family session (3 stations) Weeks 2-7: text messages with program content and questions

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Citations

1. cih.jhu.edu cih.jhu.edu/circle/

CIRCLE: Ending Substance Use Harms The CIRCLE Center will serve as a national resource and fuel a hub of Indigenous-driven research and training to understand and address substance use inequities ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04222556

Evaluation of Thiwáhe Gluwáš'Akapi Substance Use ... In summary, this study will test the effectiveness of TG for reducing risk for: (1) substance use among youth; (2) suicide risk among youth; and (3) substance ...

3. coloradosph.cuanschutz.edu coloradosph.cuanschutz.edu/research-and-practice/centers-programs/caianh/projects/strong-lakota-families

Strong Lakota Families | Thiwáhe Gluwáš'akapi 2 In addition to testing program effects on adolescent substance use, the study will also examine effects on youth suicide risk and adult substance use outcomes.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11942244/

Participant Perceptions of the Acceptability, Feasibility, and ... (1) Background: This study aimed to examine adult participants perceptions of the Thiwáhe Gluwáš'akapi (TG) program.

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

Examination of expanded impacts on youth and parents This study will add to the evidence base regarding the effectiveness of a substance use prevention program tailored for AI youth and families and simultaneously ...

6. mdpi.com mdpi.com/1660-4601/22/3/412

Participant Perceptions of the Acceptability, Feasibility, and ... National Survey on Drug Use and Health. 2018 NSDUH Detailed Tables. Substance Abuse and Mental Health Services Administration. 2019. Available online: https:// ...

7. researchgate.net researchgate.net/publication/370318696_Grounding_evidence-based_prevention_within_cultural_context_promising_effects_of_substance_use_prevention_adapted_for_American_Indian_families

Grounding evidence-based prevention within cultural context ... Thiwáhe Gluwáš'akapi Substance Use Prevention Program for American Indian Youth ... Data. Article. Full-text available. Nov 2003. Paul Spicer ...

8. withpower.com withpower.com/trial/native-spirit-program-for-addiction-prevention-a080f

Native Spirit Program for Addiction Prevention Substance abuse prevention in American Indian and Alaska Native communities. ... We use your data solely to fulfill our mission: helping you find clinical ...