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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
Must play a significant parenting role for the child enrolled in the study, as a parent, grandparent, other relative, legal guardian, or other household member.
At least 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 16 years of age for youth; up to 30 years for adults
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
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I am a key caregiver for the child in the study.
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I am 18 years old or older.
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I am between 10 and 12 years old.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Alcohol initiation
Alcohol intoxication initiation
Chewing tobacco initiation
+42 more
Secondary outcome measures
Antisocial behavior [youth only]
Association with deviant peers [youth only]
Awareness of Connectedness scale (adapted) [youth only]
+29 more
Other outcome measures
Daily fruit and vegetable consumption
Daily sugary drink consumption
Daily water consumption
+3 more

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

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,722 Previous Clinical Trials
2,112,950 Total Patients Enrolled
2 Trials studying Substance Abuse
1,029 Patients Enrolled for Substance Abuse
National Institute on Drug Abuse (NIDA)NIH
2,445 Previous Clinical Trials
2,593,424 Total Patients Enrolled
152 Trials studying Substance Abuse
706,590 Patients Enrolled for Substance Abuse
Nancy R Whitesell, PhDPrincipal InvestigatorUniversity of Colorado - Anschutz Medical Campus
1 Previous Clinical Trials
449 Total Patients Enrolled

Media Library

Thiwáhe Gluwáš'akapi Clinical Trial Eligibility Overview. Trial Name: NCT04222556 — N/A
Substance Abuse Research Study Groups: Thiwáhe Gluwáš'akapi, Woyute Waśte
Substance Abuse Clinical Trial 2023: Thiwáhe Gluwáš'akapi Highlights & Side Effects. Trial Name: NCT04222556 — N/A
Thiwáhe Gluwáš'akapi 2023 Treatment Timeline for Medical Study. Trial Name: NCT04222556 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research project presently open for enrolment?

"Based on the information provided by clinicaltrials.gov, this trial is not presently recruiting participants and has been in a dormant state since April 12th 2022. However, there are currently 521 other trials actively searching for candidates at this time."

Answered by AI

What outcomes is this research endeavor attempting to prove?

"This clinical trial, which is assessed over a Change from baseline to 36 months after intervention period, aims to reduce the initiation of cigarette smoking. Secondary outcomes include trajectories of change in Substance use attitudes [youth only], Parent warmth [adult reports] and Past week depression [youth only]. These targets are measured at regular 6-month intervals for three years."

Answered by AI

To which population is this research initiative accessible?

"The criteria for a potential participant in this suicide prevention trial is between 10 to 85 years old. Furthermore, they must meet the following conditions: being aged 10-12 on the first day of participation and attending school at an eligible reservation; enrolling with an adult of legal age (18+) who has a significant parenting role in their life such as parent/grandparent or other household member."

Answered by AI

Does this clinical trial extend its reach to senior citizens?

"The age range for suitable applicants to this medical trial is between 10 and 85 years old."

Answered by AI
~101 spots leftby Feb 2025