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Thiwáhe Gluwáš'akapi for Substance Abuse Prevention

N/A

Waitlist Available

Led By Nancy R Whitesell, PhD

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least 18 years old

10-12 years old on the date of the first program session

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 16 years of age for youth; up to 30 years for adults

Awards & highlights

No Placebo-Only Group

Summary

This trial will test the effectiveness of an adapted Strengthening Families Program, called Thiwáhe Gluwáš'akapi, for delaying the onset of substance use and reducing suicide risk among young adolescents, as well as reducing substance abuse among adults.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this intervention involves educational and community engagement rather than medical treatment, traditional side effects are not applicable. However, participants may experience emotional discomfort discussing sensitive topics.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

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I am between 10 and 12 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 16 years of age for youth; up to 30 years for adults

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 16 years of age for youth; up to 30 years for adults

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 16 years of age for youth; up to 30 years for adults for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Alcohol initiation

Alcohol intoxication initiation

Chewing tobacco initiation

+42 more

Secondary study objectives

Antisocial behavior [youth only]

Association with deviant peers [youth only]

Awareness of Connectedness scale (adapted) [youth only]

+29 more

Other study objectives

Daily fruit and vegetable consumption

Daily sugary drink consumption

Daily water consumption

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Thiwáhe Gluwáš'akapiExperimental Treatment1 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 WaśteActive Control1 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

0 / 2Eligibility criteria met