NCT02383225

Brief Summary

This study involves adaptation, implementation, and rigorous evaluation of a family-based program designed to prevent early initiation of substance use on a Northern Plains Indian reservation. The program, Thiwáhe Gluwáš'akapi, is a cultural adaptation of the Iowa Strengthening Families Program for Parents and Youth 10-14. Youth and their parents/caregivers will participate in weekly group sessions for 7 weeks and complete pre- and post-intervention surveys assessing a variety of risk and protective factors and youth outcomes. The evaluation design will allow the assessment of the effectiveness of different components within the program.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
449

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2013

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

December 30, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 9, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 4, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 4, 2018

Completed
Last Updated

March 20, 2020

Status Verified

March 1, 2020

Enrollment Period

4.6 years

First QC Date

December 30, 2014

Last Update Submit

March 18, 2020

Conditions

Substance Use

Keywords

American IndianAdolescentPrevention

Outcome Measures

Primary Outcomes (54)

  • Youth lifetime alcohol use

    Lifetime prevalence of alcohol use

    Baseline (1 week before program start)

  • Youth lifetime alcohol use

    Lifetime prevalence of alcohol use

    Post-intervention (1 week after program conclusion)

  • Youth lifetime alcohol use

    Lifetime prevalence of alcohol use

    Follow-up (6 months after program conclusion)

  • Youth past-month alcohol use

    Mean frequency of past month alcohol use

    Baseline (1 week before program start)

  • Youth past-month alcohol use

    Mean frequency of past month alcohol use

    Post-intervention (1 week after program conclusion)

  • Youth past-month alcohol use

    Mean frequency of past month alcohol use

    Follow-up (6 months after program conclusion)

  • Youth maximum alcohol use in past month

    Mean maximum quantity of past month alcohol consumption

    Baseline (1 week before program start)

  • Youth maximum alcohol use in past month

    Mean maximum quantity of past month alcohol consumption

    Post-intervention (1 week after program conclusion)

  • Youth maximum alcohol use in past month

    Mean maximum quantity of past month alcohol consumption

    Follow-up (6 months after program conclusion)

  • Youth age of first alcohol use

    Mean age of first alcohol use

    Baseline (1 week before program start)

  • Youth age of first alcohol use

    Mean age of first alcohol use

    Post-intervention (1 week after program conclusion)

  • Youth age of first alcohol use

    Mean age of first alcohol use

    Follow-up (6 months after program conclusion)

  • Youth lifetime cigarette use

    Lifetime prevalence of cigarette use

    Baseline (1 week before program start)

  • Youth lifetime cigarette use

    Lifetime prevalence of cigarette use

    Post-intervention (1 week after program conclusion)

  • Youth lifetime cigarette use

    Lifetime prevalence of cigarette use

    Follow-up (6 months after program conclusion)

  • Youth past-month cigarette use

    Mean frequency of past month cigarette use

    Baseline (1 week before program start)

  • Youth past-month cigarette use

    Mean frequency of past month cigarette use

    Post-intervention (1 week after program conclusion)

  • Youth past-month cigarette use

    Mean frequency of past month cigarette use

    Follow-up (6 months after program conclusion)

  • Youth age of first cigarette use

    Mean age of first cigarette use

    Baseline (1 week before program start)

  • Youth age of first cigarette use

    Mean age of first cigarette use

    Post-intervention (1 week after program conclusion)

  • Youth age of first cigarette use

    Mean frequency of past month cigarette use

    Follow-up (6 months after program conclusion)

  • Youth prevalence of smokeless tobacco use

    Lifetime prevalence of smokeless tobacco use

    Baseline (1 week before program start)

  • Youth prevalence of smokeless tobacco use

    Lifetime prevalence of smokeless tobacco use

    Post-intervention (1 week after program conclusion)

  • Youth prevalence of smokeless tobacco use

    Lifetime prevalence of smokeless tobacco use

    Follow-up (6 months after program conclusion)

  • Youth frequency of past-month smokeless tobacco use

    Mean frequency of past month smokeless tobacco use

    Baseline (1 week before program start)

  • Youth frequency of past-month smokeless tobacco use

    Mean frequency of past month smokeless tobacco use

    Post-intervention (1 week after program conclusion)

  • Youth frequency of past-month smokeless tobacco use

    Mean frequency of past month smokeless tobacco use

    Follow-up (6 months after program conclusion)

  • Youth age of first smokeless tobacco use

    Mean age of first smokeless tobacco use

    Baseline (1 week before program start)

  • Youth age of first smokeless tobacco use

    Mean age of first smokeless tobacco use

    Post-intervention (1 week after program conclusion)

  • Youth age of first smokeless tobacco use

    Mean age of first smokeless tobacco use

    Follow-up (6 months after program conclusion)

  • Youth lifetime prevalence of e-cigarette use

    Lifetime prevalence of e-cigarette use

    Baseline (1 week before program start)

  • Youth lifetime prevalence of e-cigarette use

    Lifetime prevalence of e-cigarette use

    Post-intervention (1 week after program conclusion)

  • Youth lifetime prevalence of e-cigarette use

    Lifetime prevalence of e-cigarette use

    Follow-up (6 months after program conclusion)

  • Youth past-month e-cigarette use

    Mean frequency of past month e-cigarette use

    Baseline (1 week before program start)

  • Youth past-month e-cigarette use

    Mean frequency of past month e-cigarette use

    Post-intervention (1 week after program conclusion)

  • Youth past-month e-cigarette use

    Mean frequency of past month e-cigarette use

    Follow-up (6 months after program conclusion)

  • Youth lifetime marijuana use

    Lifetime prevalence of marijuana use

    Baseline (1 week before program start)

  • Youth lifetime marijuana use

    Lifetime prevalence of marijuana use

    Post-intervention (1 week after program conclusion)

  • Youth lifetime marijuana use

    Lifetime prevalence of marijuana use

    Follow-up (6 months after program conclusion)

  • Youth past-month marijuana use

    Mean frequency of past month marijuana use

    Baseline (1 week before program start)

  • Youth past-month marijuana use

    Mean frequency of past month marijuana use

    Post-intervention (1 week after program conclusion)

  • Youth past-month marijuana use

    Mean frequency of past month marijuana us

    Follow-up (6 months after program conclusion)

  • Youth age of first marijuana use

    Mean age of first marijuana use

    Baseline (1 week before program start)

  • Youth age of first marijuana use

    Mean age of first marijuana use

    Post-intervention (1 week after program conclusion)

  • Youth age of first marijuana use

    Mean age of first marijuana use

    Follow-up (6 months after program conclusion)

  • Youth lifetime prevalence of huffing glue/gas

    Lifetime prevalence of huffing

    Baseline (1 week before program start)

  • Youth lifetime prevalence of huffing glue/gas

    Lifetime prevalence of huffing

    Post-intervention (1 week after program conclusion)

  • Youth lifetime prevalence of huffing glue/gas

    Lifetime prevalence of huffing

    Follow-up (6 months after program conclusion)

  • Youth past-month huffing

    Mean frequency of past month huffing

    Baseline (1 week before program start)

  • Youth past-month huffing

    Mean frequency of past month huffing

    Post-intervention (1 week after program conclusion)

  • Youth past-month huffing

    Mean frequency of past month huffing

    Follow-up (6 months after program conclusion)

  • Youth age of first huffing

    Mean age of first huffing

    Baseline (1 week before program start)

  • Youth age of first huffing

    Mean age of first huffing

    Post-intervention (1 week after program conclusion)

  • Youth age of first huffing

    Mean age of first huffing

    Follow-up (6 months after program conclusion)

Secondary Outcomes (275)

  • Youth perceived consistency of parental discipline practices

    baseline (1 week before program start)

  • Youth perceived consistency of parental discipline practices

    post-intervention (1 week after program conclusion)

  • Youth perceived consistency of parental discipline practices

    follow-up (6 months after program conclusion)

  • Youth perceived parental standard setting

    baseline (1 week before program start)

  • Youth perceived parental standard setting

    post-intervention (1 week after program conclusion)

  • +270 more secondary outcomes

Study Arms (4)

Condition A

EXPERIMENTAL

Substance use resistance skills; no Lakota language enhancement, no FaceBook supplement

Behavioral: Substance Use Resistance Skills

Condition B

EXPERIMENTAL

FaceBook supplement; no Lakota language enhancement; no Substance Use resistance skills

Behavioral: Facebook Supplement

Condition C

EXPERIMENTAL

Lakota language enhancement; no FaceBook supplement; no Substance Use resistance skills

Behavioral: Lakota Language enhancement

Condition D

EXPERIMENTAL

Lakota language enhancement; FaceBook supplement; Substance Use resistance skills

Behavioral: Lakota Language enhancementBehavioral: Facebook SupplementBehavioral: Substance Use Resistance Skills

Interventions

Lakota Language enhancementBEHAVIORAL

This intervention component includes more extensive adaptation for Lakota families, focusing on use of Lakota language specifically around relationship/kinship terms. Study arms without this component will include the same adapted intervention but with use of English language rather than Lakota.

Condition CCondition D
Facebook SupplementBEHAVIORAL

This intervention component includes a social media supplement to engage families outside of weekly intervention sessions and will include postings and polls for participating parents/other caregivers to complete between sessions.

Condition BCondition D
Substance Use Resistance SkillsBEHAVIORAL

This intervention component consists of the original substance use resistance skills training from the Iowa Strengthening Families Program for Parents and Youth 10-14; arms without this component will include a session on healthy eating and exercise (attention control).

Condition ACondition D

Eligibility Criteria

Age10 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Youth aged 10-14 years and their families, with connection to the South Dakota Indian Reservation where the study is being conducted. Families may include parents, extended family, guardians, and others living in the household.

You may not qualify if:

  • Individuals without a child in the family aged 10-14 will not be allowed to participate.
  • Youth who are not between 10 and 14 years of age will not be allowed to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Nancy R Whitesell, PhD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 30, 2014

First Posted

March 9, 2015

Study Start

June 15, 2013

Primary Completion

January 4, 2018

Study Completion

January 4, 2018

Last Updated

March 20, 2020

Record last verified: 2020-03

Locations

US(1)