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

552 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Researchers at the Centers for American Indian and Alaska Native Health in the Colorado School of Public Health at the University of Colorado completed an intensive community-engaged process to rigorously adapt the Strengthening Families Program for Parents and Youth 10-14 for the cultural context of a Northern Plains reservation community, creating a program optimized for American Indian families, Thiwáhe Gluwáš'akapi (TG, sacred home in which family is made strong). This study will test the effectiveness of TG for delaying the onset of substance use among young adolescents. In response to requests from participating families and community partners to help address suicide risk among their youth, and based on preliminary evidence that the program may impact risk behaviors beyond substance use, the study will also test suicide risk outcomes among youth. Finally, in recognition of the potential for reciprocal influence on the adults participating in the program with their children, capitalizing on their motivation to make concomitant positive changes in their own lives, the current study will also examine effects on adult 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 abuse among adults.

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+