Evaluation of Thiwáhe Gluwáš'Akapi Substance Use Prevention Program

NCT04222556 | Unknown DMC

• 2 other identifiers: 18-2559R37DA047926
• Study Type: interventional
• Target: 552
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Substance Use; Substance Abuse; Suicide

Keywords

American Indian; Adolescent; Parenting; Family; Prevention

Outcome Measures

Primary Outcomes (45)

• Lifetime alcohol use

  Percentage reporting lifetime alcohol use (measured at baseline, post-test, and 6 month intervals for 36 months)

  Change from baseline to 36 months after intervention

• Alcohol initiation

  Age of first reported alcohol use

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

• Past month frequency of any alcohol use

  Trajectory of frequency of past month alcohol use (# days, measured at baseline, post-test, and 6 month intervals for 36 months)

  Change from baseline to 36 months after intervention

• Past month frequency of consumption of 4+ (for females) or 5+ (for males) alcoholic drinks at one time

  Trajectory of frequency of past month alcohol consumption of 4+ drinks (for females) or 5+ (for males) (# days, measured at baseline, post-test, and 6 month intervals for 36 months)

  Change from baseline to 36 months after intervention

• Past month usual quantity of alcohol use [adults only]

  Trajectory of usual quantity of alcohol use in past month (# drinks, measured at baseline, post-test, and 6 month intervals for 36 months)

  Change from baseline to 36 months after intervention

• Lifetime alcohol intoxication

  Percentage reporting lifetime alcohol intoxication (measured at baseline, post-test, and 6 month intervals for 36 months)

  Change from baseline to 36 months after intervention

• Alcohol intoxication initiation

  Age of first reported alcohol intoxication

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

• Past month frequency of intoxication

  Trajectory of frequency of past month alcohol intoxication (# days, measured at baseline, post-test, and 6 month intervals for 36 months)

  Change from baseline to 36 months after intervention

• Lifetime use of cough syrup (without parental permission) [youth only]

  Percentage reporting use of cough syrup (without parental permission) (measured at baseline, post-test, and 6 month intervals for 36 months)

  Change from baseline to 36 months after intervention

• Cough syrup use initiation (without parental permission) [youth only]

  Age of first reported non-medical cough syrup use

  Up to 16 years of age

• Past month frequency of use of cough syrup without parental permission [youth only]

  Trajectory of frequency of past month use of cough syrup without parental permission (# days, measured at baseline, post-test, and 6 month intervals for 36 months)

  Change from baseline to 36 months after intervention

• Past month quantity of use of cough syrup without parental permission [youth only]

  Trajectory of quantity of past month cough syrup used without parental permission (1 or 2 teaspoons (0); ¼ of the bottle (1); ½ of the bottle (2); One whole bottle (3); More than one bottle (4); measured at baseline, post-test, and 6 month intervals for 36 months)

  Change from baseline to 36 months after intervention

• Lifetime marijuana use

  Percentage reporting lifetime marijuana use (measured at baseline, post-test, and 6 month intervals for 36 months)

  Change from baseline to 36 months after intervention

• Marijuana initiation

  Age of first reported marijuana use

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

• Past month frequency of marijuana use

  Trajectory of frequency of past month marijuana use (# days, measured at baseline, post-test, and 6 month intervals for 36 months)

  Change from baseline to 36 months after intervention

• Lifetime cigarette use

  Percentage reporting lifetime cigarette use (measured at baseline, post-test, and 6 month intervals for 36 months)

  Change from baseline to 36 months after intervention

• Cigarette initiation

  Age of first reported cigarette use

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

• Past month frequency of cigarette use

  Trajectory of frequency of past month cigarette use (# days, measured at baseline, post-test, and 6 month intervals for 36 months)

  Change from baseline to 36 months after intervention

• Lifetime use of electronic vapor products

  Percentage reporting use of electronic vapor products (measured at baseline, post-test, and 6 month intervals for 36 months)

  Change from baseline to 36 months after intervention

• Electronic vapor products initiation

  Age of first reported electronic vapor product use

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

• Past month frequency of electronic vapor product use

  Trajectory of frequency of past month electronic vapor product use (# days, measured at baseline, post-test, and 6 month intervals for 36 months)

  Change from baseline to 36 months after intervention

• Lifetime chewing tobacco use

  Percentage reporting chewing tobacco use (measured at baseline, post-test, and 6 month intervals for 36 months)

  Change from baseline to 36 months after intervention

• Chewing tobacco initiation

  Age of first reported chewing tobacco use

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

• Past month frequency of chewing tobacco use

  Trajectory of frequency of past month chewing tobacco use (# days, measured at baseline, post-test, and 6 month intervals for 36 months)

  Change from baseline to 36 months after intervention

• Lifetime inhalant use

  Percentage reporting inhalant use (measured at baseline, post-test, and 6 month intervals for 36 months)

  Change from baseline to 36 months after intervention

• Inhalant use initiation

  Age of first reported inhalant use

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

• Past month frequency of inhalant use

  Trajectory of frequency of past month inhalant use (# days, measured at baseline, post-test, and 6 month intervals for 36 months)

  Change from baseline to 36 months after intervention

• Lifetime prescription pain medicine use without a prescription or other than as prescribed [youth aged 13+ and adults only]

  Percentage reporting non-medical use of prescription pain medicine (measured at baseline, post-test, and 6 month intervals for 36 months)

  Change from baseline to 36 months after intervention

• Prescription pain medicine use (non-medical) initiation

  Age of first reported non-medical prescription pain medicine use

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

• Lifetime frequency of prescription pain medicine use without a prescription or other than as prescribed [adults only]

  Trajectory of frequency of lifetime non-medical pain medicine use (# times, measured at baseline, post-test, and 6 month intervals for 36 months)

  Change from baseline to 36 months after intervention

• Past month frequency of prescription pain medicine use without a prescription or other than as prescribed [youth aged 13+ and adults only]

  Trajectory of frequency of past month non-medical prescription pain medicine use (# days, measured at baseline, post-test, and 6 month intervals for 36 months)

  Change from baseline to 36 months after intervention

• Lifetime cocaine use [youth aged 13+ and adults only]

  Percentage cocaine use (measured at baseline, post-test, and 6 month intervals for 36 months)

  Change from baseline to 36 months after intervention

• Cocaine use initiation

  Age of first reported cocaine use

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

• Lifetime frequency of cocaine use [adults only]

  Trajectory of frequency of lifetime cocaine use (# times, measured at baseline, post-test, and 6 month intervals for 36 months)

  Change from baseline to 36 months after intervention

• Past month frequency of cocaine use [youth aged 13+ and adults only]

  Trajectory of frequency of past month cocaine use (# days, measured at baseline, post-test, and 6 month intervals for 36 months)

  Change from baseline to 36 months after intervention

• Lifetime methamphetamine use [youth aged 13+ and adults only]

  Percentage methamphetamine use (measured at baseline, post-test, and 6 month intervals for 36 months)

  Change from baseline to 36 months after intervention

• Methamphetamine use initiation

  Age of first reported methamphetamine use

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

• Lifetime frequency of methamphetamine use [adults only]

  Trajectory of frequency of lifetime methamphetamine use (# times, measured at baseline, post-test, and 6 month intervals for 36 months)

  Change from baseline to 36 months after intervention

• Past month frequency of methamphetamine use [youth aged 13+ and adults only]

  Trajectory of frequency of past month methamphetamine use (# days, measured at baseline, post-test, and 6 month intervals for 36 months)

  Change from baseline to 36 months after intervention

• Lifetime heroin use [adults only]

  Percentage heroin use (measured at baseline, post-test, and 6 month intervals for 36 months)

  Change from baseline to 36 months after intervention

• Heroin use initiation

  Age of first reported heroin use

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

• Lifetime frequency of heroin use [youth aged 13+ and adults only]

  Trajectory of frequency of lifetime heroin use (# times, measured at baseline, post-test, and 6 month intervals for 36 months)

  Change from baseline to 36 months after intervention

• Past month frequency of heroin use [youth aged 13+ and adults only]

  Trajectory of frequency of past month heroin use (# days, measured at baseline, post-test, and 6 month intervals for 36 months)

  Change from baseline to 36 months after intervention

• Lifetime suicidal ideation [youth only]

  Youth Risk Behavior Survey, middle school version, adapted to lifetime (ever seriously thought about suicide, ever made a plan, ever attempted); scored 0 to 3.

  Change from baseline to 36 months after intervention

• Past month suicidal ideation [youth only]

  Youth Risk Behavior Survey items adapted to past month time frame; Middle school version for youth up to age 12 (scored 0-3); High school version for youth aged 13+ (scored 0-8).

  Change from baseline to 36 months after intervention

Secondary Outcomes (32)

• Parent communication about alcohol and drugs [youth and adult reports]

  Change from baseline to 36 months after intervention

• Parent rules about substance use [youth and adult reports]

  Change from baseline to 36 months after intervention

• Substance use attitudes [youth only]

  Change from baseline to 36 months after intervention

• Substance use norms [youth only]

  Change from baseline to 36 months after intervention

• Antisocial behavior [youth only]

  Change from baseline to 36 months after intervention

Other Outcomes (6)

• Daily fruit and vegetable consumption

  Baseline, post-test (1 week post-intervention), follow-up at 6 months, 12 months, 18 months, 24 months, 30 months, and 36 months

• Weekly physical activity

  Baseline, post-test (1 week post-intervention), follow-up at 6 months, 12 months, 18 months, 24 months, 30 months, and 36 months

• Daily water consumption

  Baseline, post-test (1 week post-intervention), follow-up at 6 months, 12 months, 18 months, 24 months, 30 months, and 36 months

Study Arms (2)

Thiwáhe Gluwáš'akapi

EXPERIMENTAL

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

Behavioral: Thiwáhe Gluwáš'akapi

Woyute Waśte

ACTIVE COMPARATOR

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

Behavioral: Woyute Waśte

Interventions

Thiwáhe Gluwáš'akapi BEHAVIORAL

Thiwáhe Gluwáš'akapi (TG, sacred home in which family is made strong) is a cultural adaptation of the Strengthening Families Program for Parents and Youth 10-14 (SFP 10-14). TG, like SFP 10-14, is a 7-week family-based prevention program with separate youth and adult sessions followed by family sessions. Videos teach content and spark discussion; games and activities foster interaction and provide opportunities to practice skills. Four key adaptations were made to create TG: (1) cultural kinship teachings and tribal language kinship words were embedded throughout; (2) a parent session on coping with stress was enhanced to teach recognizing and responding to trauma reactions in youth; (3) a session on listening was moved earlier in the curriculum, given cultural oral tradition; (4) session videos were remade with local actors and adapted scenarios. A multiphase optimization strategy design was used to test potential adaptations, resulting in the optimized TG program.

Thiwáhe Gluwáš'akapi

Woyute Waśte BEHAVIORAL

Woyute Waśte (WW) was adapted from the Colorado School of Public Health's Integrated Nutrition Education Program (INEP) for the culture and context of the reservation. Families will meet for 1 session to participate in hands-on activities - preparing healthy meals, family physical activity, and sugary drinks. They will discuss setting healthy goals and tracking progress, receive recipes and water bottles, and for 6 weeks after the session, will get text messages with additional program content.

Woyute Waśte

Eligibility Criteria

• Age: 10 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Youth participants:
• years old on the date of the first program session
• Attending school on the reservation
• Must enroll with an eligible adult
• Adult participants:
• At least 18 years old
• Must enroll with an eligible child
• 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.

You may not qualify if:

• Prisoners
• Decisionally-challenged adults

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Related Publications (2)

• Ivanich JD, Mousseau AC, Walls M, Whitbeck L, Whitesell NR. Pathways of Adaptation: Two Case Studies with One Evidence-Based Substance Use Prevention Program Tailored for Indigenous Youth. Prev Sci. 2020 Jan;21(Suppl 1):43-53. doi: 10.1007/s11121-018-0914-5.

  PMID: 29876790 BACKGROUND

• Whitesell NR, Mousseau AC, Keane EM, Asdigian NL, Tuitt N, Morse B, Zacher T, Dick R, Mitchell CM, Kaufman CE. Integrating Community-Engagement and a Multiphase Optimization Strategy Framework: Adapting Substance Use Prevention for American Indian Families. Prev Sci. 2019 Oct;20(7):1136-1146. doi: 10.1007/s11121-019-01036-y.

  PMID: 31376058 BACKGROUND

MeSH Terms

Conditions

Substance-Related Disorders; Suicide

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Nancy R Whitesell, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2019
• First Posted: January 10, 2020
• Study Start: February 26, 2020
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: December 22, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Anticipated availability in late 2024, for a period of at least 5 years.
• Access Criteria: See Plan Description for details of access requests through Data Access Committee.

Locations

US (1)