Culturally Grounded Early Substance Use Prevention for American Indian Families

Substance Use Clinical Trial

Official title:

Culturally Grounded Early Substance Use Prevention for American Indian Families

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02383225
• Other study ID #: 12-1641
• Status: Completed
• Phase: N/A
• Start date: June 15, 2013
• Est. completion date: January 4, 2018

Study information

• Verified date: March 2020
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Feasibility Pilot

A feasibility pilot for the Thiwáhe Gluwáš'akapi (TG) program will be conducted in the Spring of 2015. In the pilot, the intervention will be delivered to two groups of youth and families and the implementation process will be carefully evaluated to determine what works well and where further adaptation of the intervention or the study procedures may be necessary. Particular attention will be paid to retention of families and, if possible, any who drop out will be interviewed to understand barriers to participation.

As with the intervention evaluation itself (see below) youth aged 10-14 will be recruited to participate, along with their parents and/or other adults (up to 3 adults per child) who are actively involved in raising them (e.g., grandparents, aunts, uncles). Pilot groups will be conducted in each of two different communities on the reservation.

Once the feasibility pilot is complete, the intervention will be finalized for efficacy evaluation. Tasks for this phase will include refining the manual for the intervention and further developing training materials for interventionists.

Implementation/Component Evaluation

The formal evaluation of TG will begin in the fall of 2015 and will utilize the principles of Multiphase Optimization Strategy (MOST; Collins et al., 2009) for intervention development and a fractional factorial design to evaluate the relative effectiveness of different components within the intervention. Three components will be evaluated: (1) A Lakota language enhancement (Lakota), (2) a Facebook social media enhancement (FB), and (3) substance use resistance skill content (SU). A total of 24 intervention groups will be randomly assigned to one of 4 MOST design conditions, with the content of each condition determined using SAS PROC FACTEX, as recommended by Collins, et al, 2009. All 4 conditions will consist of the basic TG program, each supplemented by one or more of 3 components designated above: Condition A will include the substance use resistance content (SU; no Lakota or FB); Condition B will include the FB social media supplement (FB; no Lakota or SU); Condition C will include the Lakota language enhancement (Lakota; no FB or SU); and Condition D will include all three components (Lakota + FB + SU).

A cumulative evidence design will be utilized, with the intervention implemented in 5 cohorts across 3 years. The intervention will be delivered to 4 groups (8 families each) in Cohort 1 in the fall of 2015. Additional cohorts will receive the intervention each fall and spring through 2017 as follows: Cohort 2, Spring 2016, 4 groups; Cohort 3, Fall 2016, 6 groups; Cohort 4, Spring 2017, 6 groups; and Cohort 5, Fall 2017, 4 groups. Thus, by the end of 2017, 24 intervention groups (each 8 families, total of 192 families) will have participated in the TG program. Cohorts will be randomly assigned to the 4 MOST design conditions in order to control for potential order of implementation effects.

Power analysis

Power analyses suggest that this design will result in adequate power (>.80) to detect a small effect (d=.15) with 48 families per condition; for the 4 conditions in the design, this will require a total of 192 families (not including 16 pilot families). TG, following Iowa Strengthening Families Program (ISFP) recommendations, will be delivered in family groups of 8 families each; thus, in order to involve 192 families, we plan a total of 24 intervention groups, with 6 in each the 4 experimental conditions. Each component targeted for evaluation will be implemented in 2 of the 4 conditions (see conditions A-B above), and estimates of each effect will thus be based on marginal Ns of 96 families. As is standard with MOST designs, there will not be a no-intervention control group nor will there be a group that receives every component. While this is a different approach than an randomized controlled trial (RCT) design, it is a rigorous and optimal approach for identifying the most effective components to include in an intervention. The intervention created using this process will be ready for a standard RCT evaluation, and more likely to be proven effective there.

Implementation evaluation

Fidelity across implementations will be ensured by using a detailed manual of procedures, providing extensive training for interventionists, and using fidelity logs to asses delivery of key session components. The intervention director, a clinical psychologist, will observe sessions periodically and verify the extent to which implementation is occurring with fidelity to the TG program manual.

Efficacy evaluation

The primary impetus for the development and implementation of the TG program is the desire to reduce risk for substance abuse problems among American Indian adolescents by preventing early initiation of substance use. Assessment of the success of the TG program components will hinge on observed impacts on substance use initiation and on the putative mediators of parental self-efficacy, strengthened family relationships, and cultural knowledge and values. Given the short timeline of the outcome evaluations (limited to 6 months post-intervention), effects on mediators are anticipated to stronger than distal effects on behavioral outcomes.

Measures

Measures used to assess study outcomes draw heavily from the investigators' previous research with young American Indian adolescents and their parents, and from previous evaluations of the Iowa Strengthening Families Program for Parents and Youth 10-14. Two instruments will be used to assess an array of outcomes expected to be affected by the TG intervention, along with demographic data: a Parent Survey (for parents and other caregivers participating in the TG program with youth), and a Youth Survey. Both the Parent Survey and Youth Survey will be administered electronically, using tablet computers connected to the Internet, with data uploaded directly. In addition, a Social Network Survey will be administered (either on an electronic tablet or on paper) to participating parents/caregivers; this survey is designed to assess the strength of the connections among participants in the program, both before and after participation in the program. A small number of participants (3-4) in each group assigned to the FaceBook condition will be asked to participate in Exit Interviews (by phone) to ascertain their use of and response to the social media messages provided between TG sessions. Data will also be captured from Facebook, including page visits, posts, and responses to online quizzes. Finally, participants will be asked to complete a Program Evaluation Form (Parent or Youth versions, on paper) at their last TG session, to provide feedback on the program and facilitators.

Data Collection Schedule

Time 1 - One week prior to the first TG session: Parent and Youth surveys (all participants).

Time 2 - First TG session: Social Network Surveys (adults).

Time 3 - One week after last TG session: Parent and Youth Surveys (all participants); Social Network Survey (adults)

Time 4 - Within two weeks after final TG session: FaceBook Exit Interviews (3-4 adult participants in each condition including the FaceBook supplement)

Time 5 - Approximately 6 months after the last TG session: Parent and Youth Surveys (all participants in the first two intervention cohorts)

Analyses

The simplest analyses for the evaluation of the TG program, using the MOST design, will involve analysis of variance (ANOVA), using the fractional factorial design described above, comparing post-intervention values (Time 3 and Time 5) on both mediators and outcomes across conditions (assuming that randomization across conditions will result in roughly equivalent pre-intervention values). Repeated measures ANOVA will also be performed, including both pre- and post-intervention measures, looking for interactions between time and condition. Finally, multivariate ANOVAs will be estimated for groups of outcome variables, to examine patterns of effects across outcomes. For all analyses, the focus will be on effect sizes (rather than significance tests and p values) to compare effect sizes across components to guide decisions about what should be retained in the optimized TG intervention. As noted above, standard errors will be adjusted to account for intraclass correlations and clustering of families within intervention groups. Analyses of the Social Network Measure will focus on assessing density and cohesion at the network level, to address two primary questions: First, do network characteristics at the beginning of the program (pre-existing relationships within intervention groups) modify the effect of the TG intervention within those groups and, second, do network characteristics change over the course of the TG intervention as new relationships are formed and existing relationships changed. Analyses will be conducted using UCINET or similar social network analysis software. Analyses of the Facebook data will be primarily descriptive, examining the frequency with which participants engage with the Facebook page for their TG group by posting comments, or responding to polls or quizzes. Exploratory analyses may be used to examine correlations between group rates of Facebook use and group-level outcomes, such as increased cohesion as measured by the Social Network Analysis. Analyses of Facebook Exit Interviews will be primarily notes-based content analysis and will involve three major stages of analysis: open coding, axial coding, and selective coding.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 449
• Est. completion date: January 4, 2018
• Est. primary completion date: January 4, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 85 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Substance Use

Intervention

Behavioral:
• Lakota Language enhancement
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.
• Facebook Supplement
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.
• Substance Use Resistance Skills
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).

Locations

Country	Name	City	State
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Youth lifetime alcohol use	Lifetime prevalence of alcohol use	Baseline (1 week before program start)
Primary	Youth lifetime alcohol use	Lifetime prevalence of alcohol use	Post-intervention (1 week after program conclusion)
Primary	Youth lifetime alcohol use	Lifetime prevalence of alcohol use	Follow-up (6 months after program conclusion)
Primary	Youth past-month alcohol use	Mean frequency of past month alcohol use	Baseline (1 week before program start)
Primary	Youth past-month alcohol use	Mean frequency of past month alcohol use	Post-intervention (1 week after program conclusion)
Primary	Youth past-month alcohol use	Mean frequency of past month alcohol use	Follow-up (6 months after program conclusion)
Primary	Youth maximum alcohol use in past month	Mean maximum quantity of past month alcohol consumption	Baseline (1 week before program start)
Primary	Youth maximum alcohol use in past month	Mean maximum quantity of past month alcohol consumption	Post-intervention (1 week after program conclusion)
Primary	Youth maximum alcohol use in past month	Mean maximum quantity of past month alcohol consumption	Follow-up (6 months after program conclusion)
Primary	Youth age of first alcohol use	Mean age of first alcohol use	Baseline (1 week before program start)
Primary	Youth age of first alcohol use	Mean age of first alcohol use	Post-intervention (1 week after program conclusion)
Primary	Youth age of first alcohol use	Mean age of first alcohol use	Follow-up (6 months after program conclusion)
Primary	Youth lifetime cigarette use	Lifetime prevalence of cigarette use	Baseline (1 week before program start)
Primary	Youth lifetime cigarette use	Lifetime prevalence of cigarette use	Post-intervention (1 week after program conclusion)
Primary	Youth lifetime cigarette use	Lifetime prevalence of cigarette use	Follow-up (6 months after program conclusion)
Primary	Youth past-month cigarette use	Mean frequency of past month cigarette use	Baseline (1 week before program start)
Primary	Youth past-month cigarette use	Mean frequency of past month cigarette use	Post-intervention (1 week after program conclusion)
Primary	Youth past-month cigarette use	Mean frequency of past month cigarette use	Follow-up (6 months after program conclusion)
Primary	Youth age of first cigarette use	Mean age of first cigarette use	Baseline (1 week before program start)
Primary	Youth age of first cigarette use	Mean age of first cigarette use	Post-intervention (1 week after program conclusion)
Primary	Youth age of first cigarette use	Mean frequency of past month cigarette use	Follow-up (6 months after program conclusion)
Primary	Youth prevalence of smokeless tobacco use	Lifetime prevalence of smokeless tobacco use	Baseline (1 week before program start)
Primary	Youth prevalence of smokeless tobacco use	Lifetime prevalence of smokeless tobacco use	Post-intervention (1 week after program conclusion)
Primary	Youth prevalence of smokeless tobacco use	Lifetime prevalence of smokeless tobacco use	Follow-up (6 months after program conclusion)
Primary	Youth frequency of past-month smokeless tobacco use	Mean frequency of past month smokeless tobacco use	Baseline (1 week before program start)
Primary	Youth frequency of past-month smokeless tobacco use	Mean frequency of past month smokeless tobacco use	Post-intervention (1 week after program conclusion)
Primary	Youth frequency of past-month smokeless tobacco use	Mean frequency of past month smokeless tobacco use	Follow-up (6 months after program conclusion)
Primary	Youth age of first smokeless tobacco use	Mean age of first smokeless tobacco use	Baseline (1 week before program start)
Primary	Youth age of first smokeless tobacco use	Mean age of first smokeless tobacco use	Post-intervention (1 week after program conclusion)
Primary	Youth age of first smokeless tobacco use	Mean age of first smokeless tobacco use	Follow-up (6 months after program conclusion)
Primary	Youth lifetime prevalence of e-cigarette use	Lifetime prevalence of e-cigarette use	Baseline (1 week before program start)
Primary	Youth lifetime prevalence of e-cigarette use	Lifetime prevalence of e-cigarette use	Post-intervention (1 week after program conclusion)
Primary	Youth lifetime prevalence of e-cigarette use	Lifetime prevalence of e-cigarette use	Follow-up (6 months after program conclusion)
Primary	Youth past-month e-cigarette use	Mean frequency of past month e-cigarette use	Baseline (1 week before program start)
Primary	Youth past-month e-cigarette use	Mean frequency of past month e-cigarette use	Post-intervention (1 week after program conclusion)
Primary	Youth past-month e-cigarette use	Mean frequency of past month e-cigarette use	Follow-up (6 months after program conclusion)
Primary	Youth lifetime marijuana use	Lifetime prevalence of marijuana use	Baseline (1 week before program start)
Primary	Youth lifetime marijuana use	Lifetime prevalence of marijuana use	Post-intervention (1 week after program conclusion)
Primary	Youth lifetime marijuana use	Lifetime prevalence of marijuana use	Follow-up (6 months after program conclusion)
Primary	Youth past-month marijuana use	Mean frequency of past month marijuana use	Baseline (1 week before program start)
Primary	Youth past-month marijuana use	Mean frequency of past month marijuana use	Post-intervention (1 week after program conclusion)
Primary	Youth past-month marijuana use	Mean frequency of past month marijuana us	Follow-up (6 months after program conclusion)
Primary	Youth age of first marijuana use	Mean age of first marijuana use	Baseline (1 week before program start)
Primary	Youth age of first marijuana use	Mean age of first marijuana use	Post-intervention (1 week after program conclusion)
Primary	Youth age of first marijuana use	Mean age of first marijuana use	Follow-up (6 months after program conclusion)
Primary	Youth lifetime prevalence of huffing glue/gas	Lifetime prevalence of huffing	Baseline (1 week before program start)
Primary	Youth lifetime prevalence of huffing glue/gas	Lifetime prevalence of huffing	Post-intervention (1 week after program conclusion)
Primary	Youth lifetime prevalence of huffing glue/gas	Lifetime prevalence of huffing	Follow-up (6 months after program conclusion)
Primary	Youth past-month huffing	Mean frequency of past month huffing	Baseline (1 week before program start)
Primary	Youth past-month huffing	Mean frequency of past month huffing	Post-intervention (1 week after program conclusion)
Primary	Youth past-month huffing	Mean frequency of past month huffing	Follow-up (6 months after program conclusion)
Primary	Youth age of first huffing	Mean age of first huffing	Baseline (1 week before program start)
Primary	Youth age of first huffing	Mean age of first huffing	Post-intervention (1 week after program conclusion)
Primary	Youth age of first huffing	Mean age of first huffing	Follow-up (6 months after program conclusion)
Secondary	Youth perceived consistency of parental discipline practices	Mean perceived consistency of parental discipline practices score	baseline (1 week before program start)
Secondary	Youth perceived consistency of parental discipline practices	Mean perceived consistency of parental discipline practices score	post-intervention (1 week after program conclusion)
Secondary	Youth perceived consistency of parental discipline practices	Mean perceived consistency of parental discipline practices score	follow-up (6 months after program conclusion)
Secondary	Youth perceived parental standard setting	Mean perceived parental standard setting score	baseline (1 week before program start)
Secondary	Youth perceived parental standard setting	Mean perceived parental standard setting score	post-intervention (1 week after program conclusion)
Secondary	Youth perceived parental standard setting	Mean perceived parental standard setting score	follow-up (6 months after program conclusion)
Secondary	Youth perceived parental monitoring	Mean perceived parental monitoring score	baseline (1 week before program start)
Secondary	Youth perceived parental monitoring	Mean perceived parental monitoring score	post-intervention (1 week after program conclusion)
Secondary	Youth perceived parental monitoring	Mean perceived parental monitoring score	follow-up (6 months after program conclusion)
Secondary	Youth perceived parental positive affect	Mean perceived parental positive affect score	baseline (1 week before program start)
Secondary	Youth perceived parental positive affect	Mean perceived parental positive affect score	post-intervention (1 week after program conclusion)
Secondary	Youth perceived parental positive affect	Mean perceived parental positive affect score	follow-up (6 months after program conclusion)
Secondary	Youth perceived parental approval	Mean perceived parental approval score	baseline (1 week before program start)
Secondary	Youth perceived parental approval	Mean perceived parental approval score	post-intervention (1 week after program conclusion)
Secondary	Youth perceived parental approval	Mean perceived parental approval score	follow-up (6 months after program conclusion)
Secondary	Youth perceived parental negative affect	Mean perceived parental negative affect score	baseline (1 week before program start)
Secondary	Youth perceived parental negative affect	Mean perceived parental negative affect score	post-intervention (1 week after program conclusion)
Secondary	Youth perceived parental negative affect	Mean perceived parental negative affect score	follow-up (6 months after program conclusion)
Secondary	Youth perceived parent-child communication	Mean perceived parent-child communication score	baseline (1 week before program start)
Secondary	Youth perceived parent-child communication	Mean perceived parent-child communication score	post-intervention (1 week after program conclusion)
Secondary	Youth perceived parent-child communication	Mean perceived parent-child communication score	follow-up (6 months after program conclusion)
Secondary	Youth perceived parent-child communication about alcohol and drugs	Mean perceived parent-child communication about alcohol and drugs score	baseline (1 week before program start)
Secondary	Youth perceived parent-child communication about alcohol and drugs	Mean perceived parent-child communication about alcohol and drugs score	post-intervention (1 week after program conclusion)
Secondary	Youth perceived parent-child communication about alcohol and drugs	Mean perceived parent-child communication about alcohol and drugs score	follow-up (6 months after program conclusion)
Secondary	Youth perceived enforcement of family rules	Mean perceived enforcement of family rules score	baseline (1 week before program start)
Secondary	Youth perceived enforcement of family rules	Mean perceived enforcement of family rules score	post-intervention (1 week after program conclusion); follow-up (6 months after program conclusion)
Secondary	Youth perceived enforcement of family rules	Mean perceived enforcement of family rules score	follow-up (6 months after program conclusion)
Secondary	Youth perceived parental autonomy support	Mean perceived parental autonomy support score	baseline (1 week before program start)
Secondary	Youth perceived parental autonomy support	Mean perceived parental autonomy support score	post-intervention (1 week after program conclusion); follow-up (6 months after program conclusion)
Secondary	Youth perceived parental autonomy support	Mean perceived parental autonomy support score	follow-up (6 months after program conclusion)
Secondary	Parent-child shared activities - youth report	Count of parent-child shared activities	baseline (1 week before program start)
Secondary	Parent-child shared activities - youth report	Count of parent-child shared activities	post-intervention (1 week after program conclusion)
Secondary	Parent-child shared activities - youth report	Count of parent-child shared activities	follow-up (6 months after program conclusion)
Secondary	Family cohesion - youth report	Mean family cohesion score	baseline (1 week before program start)
Secondary	Family cohesion - youth report	Mean family cohesion score	post-intervention (1 week after program conclusion)
Secondary	Family cohesion - youth report	Mean family cohesion score	follow-up (6 months after program conclusion)
Secondary	Family conflict resolution - youth report	Mean family conflict resolution score	baseline (1 week before program start)
Secondary	Family conflict resolution - youth report	Mean family conflict resolution score	post-intervention (1 week after program conclusion)
Secondary	Family conflict resolution - youth report	Mean family conflict resolution score	follow-up (6 months after program conclusion)
Secondary	Family expressiveness - youth report	Mean family expressiveness score	baseline (1 week before program start)
Secondary	Family expressiveness - youth report	Mean family expressiveness score	post-intervention (1 week after program conclusion)
Secondary	Family expressiveness - youth report	Mean family expressiveness score	follow-up (6 months after program conclusion)
Secondary	Lakota cultural socialization - youth report	Mean Lakota cultural socialization score	baseline (1 week before program start)
Secondary	Lakota cultural socialization - youth report	Mean Lakota cultural socialization score	post-intervention (1 week after program conclusion)
Secondary	Lakota cultural socialization - youth report	Mean Lakota cultural socialization score	follow-up (6 months after program conclusion)
Secondary	Youth perceived parental disapproval of alcohol, tobacco, and marijuana	Mean disapproval of alcohol, tobacco, and marijuana score	baseline (1 week before program start)
Secondary	Youth perceived parental disapproval of alcohol, tobacco, and marijuana	Mean disapproval of alcohol, tobacco, and marijuana score	post-intervention (1 week after program conclusion)
Secondary	Youth perceived parental disapproval of alcohol, tobacco, and marijuana	Mean disapproval of alcohol, tobacco, and marijuana score	follow-up (6 months after program conclusion)
Secondary	Descriptive norms for alcohol, tobacco, and marijuana - youth report	Mean descriptive norms for alcohol, tobacco, and marijuana score	baseline (1 week before program start)
Secondary	Descriptive norms for alcohol, tobacco, and marijuana - youth report	Mean descriptive norms for alcohol, tobacco, and marijuana score	post-intervention (1 week after program conclusion)
Secondary	Descriptive norms for alcohol, tobacco, and marijuana - youth report	Mean descriptive norms for alcohol, tobacco, and marijuana score	follow-up (6 months after program conclusion)
Secondary	Youth antisocial behavior	Mean antisocial behavior score	baseline (1 week before program start)
Secondary	Youth antisocial behavior	Mean antisocial behavior score	post-intervention (1 week after program conclusion)
Secondary	Youth antisocial behavior	Mean antisocial behavior score	follow-up (6 months after program conclusion)
Secondary	Youth prosocial behavior	Mean prosocial behavior score	baseline (1 week before program start)
Secondary	Youth prosocial behavior	Mean prosocial behavior score	post-intervention (1 week after program conclusion)
Secondary	Youth prosocial behavior	Mean prosocial behavior score	follow-up (6 months after program conclusion)
Secondary	Youth deviant peer influences	Mean deviant peer influences score	baseline (1 week before program start)
Secondary	Youth deviant peer influences	Mean deviant peer influences score	post-intervention (1 week after program conclusion)
Secondary	Youth deviant peer influences	Mean deviant peer influences score	follow-up (6 months after program conclusion)
Secondary	Youth prosocial peer influences	Mean prosocial peer influences score	baseline (1 week before program start)
Secondary	Youth prosocial peer influences	Mean prosocial peer influences score	post-intervention (1 week after program conclusion)
Secondary	Youth prosocial peer influences	Mean prosocial peer influences score	follow-up (6 months after program conclusion)
Secondary	Youth peer resistance skills	Mean peer resistance skills score	baseline (1 week before program start)
Secondary	Youth peer resistance skills	Mean peer resistance skills score	post-intervention (1 week after program conclusion)
Secondary	Youth peer resistance skills	Mean peer resistance skills score	follow-up (6 months after program conclusion)
Secondary	Youth lifetime history of stressful life events	Count of stressful events	baseline (1 week before program start)
Secondary	Youth lifetime history of stressful life events	Count of stressful events	post-intervention (1 week after program conclusion)
Secondary	Youth lifetime history of stressful life events	Count of stressful events	follow-up (6 months after program conclusion)
Secondary	Youth stress management skills	Mean stress management skills score	baseline (1 week before program start)
Secondary	Youth stress management skills	Mean stress management skills score	post-intervention (1 week after program conclusion)
Secondary	Youth stress management skills	Mean stress management skills score	follow-up (6 months after program conclusion)
Secondary	Youth psychological well-being	Mean psychological well-being score	baseline (1 week before program start)
Secondary	Youth psychological well-being	Mean psychological well-being score	post-intervention (1 week after program conclusion)
Secondary	Youth psychological well-being	Mean psychological well-being score	follow-up (6 months after program conclusion)
Secondary	Youth knowledge of Lakota kinship terminology	Count of correct Lakota kinship terms	baseline (1 week before program start)
Secondary	Youth knowledge of Lakota kinship terminology	Count of correct Lakota kinship terms	post-intervention (1 week after program conclusion)
Secondary	Youth knowledge of Lakota kinship terminology	Count of correct Lakota kinship terms	follow-up (6 months after program conclusion)
Secondary	Youth self-esteem	Mean self-esteem score	baseline (1 week before program start)
Secondary	Youth self-esteem	Mean self-esteem score	post-intervention (1 week after program conclusion)
Secondary	Youth self-esteem	Mean self-esteem score	follow-up (6 months after program conclusion)
Secondary	General parent-child communication - parent/guardian report	Mean general parent-child communication score	baseline (1 week before program start)
Secondary	General parent-child communication - parent/guardian report	Mean general parent-child communication score	post-intervention (1 week after program conclusion)
Secondary	General parent-child communication - parent/guardian report	Mean general parent-child communication score	follow-up (6 months after program conclusion)
Secondary	Parent-child communication about family issues - parent/guardian report	Mean general parent-child communication about family issues score	baseline (1 week before program start)
Secondary	Parent-child communication about family issues - parent/guardian report	Mean general parent-child communication about family issues score	post-intervention (1 week after program conclusion)
Secondary	Parent-child communication about family issues - parent/guardian report	Mean general parent-child communication about family issues score	follow-up (6 months after program conclusion)
Secondary	Parent-child communication about alcohol and drugs - parent/guardian report	Mean parent-child communication about alcohol and drugs score	baseline (1 week before program start)
Secondary	Parent-child communication about alcohol and drugs - parent/guardian report	Mean parent-child communication about alcohol and drugs score	post-intervention (1 week after program conclusion)
Secondary	Parent-child communication about alcohol and drugs - parent/guardian report	Mean parent-child communication about alcohol and drugs score	follow-up (6 months after program conclusion)
Secondary	Parent/guardian report of youth behavior	Mean youth behavior score	baseline (1 week before program start)
Secondary	Parent/guardian report of youth behavior	Mean youth behavior score	post-intervention (1 week after program conclusion)
Secondary	Parent/guardian report of youth behavior	Mean youth behavior score	follow-up (6 months after program conclusion)
Secondary	Parent/guardian report parent-child shared activities	Count of shared activities	baseline (1 week before program start)
Secondary	Parent/guardian report parent-child shared activities	Count of shared activities	post-intervention (1 week after program conclusion)
Secondary	Parent/guardian report parent-child shared activities	Count of shared activities	follow-up (6 months after program conclusion)
Secondary	Parental monitoring - parent/guardian report	Mean parental monitoring score	baseline (1 week before program start)
Secondary	Parental monitoring - parent/guardian report	Mean parental monitoring score	post-intervention (1 week after program conclusion)
Secondary	Parental monitoring - parent/guardian report	Mean parental monitoring score	follow-up (6 months after program conclusion)
Secondary	General family rules - parent/guardian report	Mean family rules score	baseline (1 week before program start)
Secondary	General family rules - parent/guardian report	Mean family rules score	post-intervention (1 week after program conclusion)
Secondary	General family rules - parent/guardian report	Mean family rules score	follow-up (6 months after program conclusion)
Secondary	Family rules about substance use - parent/guardian report	Mean substance use rules score	baseline (1 week before program start)
Secondary	Family rules about substance use - parent/guardian report	Mean substance use rules score	post-intervention (1 week after program conclusion)
Secondary	Family rules about substance use - parent/guardian report	Mean substance use rules score	follow-up (6 months after program conclusion)
Secondary	Parent discipline practices	Mean parent discipline practices score	baseline (1 week before program start)
Secondary	Parent discipline practices	Mean parent discipline practices score	post-intervention (1 week after program conclusion)
Secondary	Parent discipline practices	Mean parent discipline practices score	follow-up (6 months after program conclusion)
Secondary	Other household member discipline practices	Mean other household member discipline practices score	baseline (1 week before program start)
Secondary	Other household member discipline practices	Mean other household member discipline practices score	post-intervention (1 week after program conclusion)
Secondary	Other household member discipline practices	Mean other household member discipline practices score	follow-up (6 months after program conclusion)
Secondary	Standard setting	Mean standard setting score	baseline (1 week before program start)
Secondary	Standard setting	Mean standard setting score	post-intervention (1 week after program conclusion)
Secondary	Standard setting	Mean standard setting score	follow-up (6 months after program conclusion)
Secondary	Parent-child conflict, parent/guardian report	Mean parent-child conflict score	baseline (1 week before program start)
Secondary	Parent-child conflict, parent/guardian report	Mean parent-child conflict score	post-intervention (1 week after program conclusion)
Secondary	Parent-child conflict, parent/guardian report	Mean parent-child conflict score	follow-up (6 months after program conclusion)
Secondary	Parent support, parent/guardian report	Mean parent support score	baseline (1 week before program start)
Secondary	Parent support, parent/guardian report	Mean parent support score	post-intervention (1 week after program conclusion)
Secondary	Parent support, parent/guardian report	Mean parent support score	follow-up (6 months after program conclusion)
Secondary	Parental positive affect, parent/guardian report	Mean parental positive affect score	baseline (1 week before program start)
Secondary	Parental positive affect, parent/guardian report	Mean parental positive affect score	post-intervention (1 week after program conclusion)
Secondary	Parental positive affect, parent/guardian report	Mean parental positive affect score	follow-up (6 months after program conclusion)
Secondary	Parental negative affect, parent/guardian report	Mean parental negative affect score	baseline (1 week before program start)
Secondary	Parental negative affect, parent/guardian report	Mean parental negative affect score	post-intervention (1 week after program conclusion)
Secondary	Parental negative affect, parent/guardian report	Mean parental negative affect score	follow-up (6 months after program conclusion)
Secondary	Parental anger management, parent/guardian report	Mean parental anger management score	baseline (1 week before program start)
Secondary	Parental anger management, parent/guardian report	Mean parental anger management score	post-intervention (1 week after program conclusion)
Secondary	Parental anger management, parent/guardian report	Mean parental anger management score	follow-up (6 months after program conclusion)
Secondary	Parental self-efficacy	Mean parental self-efficacy	baseline (1 week before program start)
Secondary	Parental self-efficacy	Mean parental self-efficacy	post-intervention (1 week after program conclusion)
Secondary	Parental self-efficacy	Mean parental self-efficacy	follow-up (6 months after program conclusion)
Secondary	Family meetings, parent/guardian report	Mean family meetings score	baseline (1 week before program start)
Secondary	Family meetings, parent/guardian report	Mean family meetings score	post-intervention (1 week after program conclusion)
Secondary	Family meetings, parent/guardian report	Mean family meetings score	follow-up (6 months after program conclusion)
Secondary	Family cohesion, parent/guardian report	Mean family cohesion score	baseline (1 week before program start)
Secondary	Family cohesion, parent/guardian report	Mean family cohesion score	post-intervention (1 week after program conclusion
Secondary	Family cohesion, parent/guardian report	Mean family cohesion score	follow-up (6 months after program conclusion)
Secondary	Family conflict resolution, parent/guardian report	Mean family conflict resolution score	baseline (1 week before program start)
Secondary	Family conflict resolution, parent/guardian report	Mean family conflict resolution score	post-intervention (1 week after program conclusion)
Secondary	Family conflict resolution, parent/guardian report	Mean family conflict resolution score	follow-up (6 months after program conclusion)
Secondary	Family expressiveness, parent/guardian report	Mean family expressiveness score	baseline (1 week before program start)
Secondary	Family expressiveness, parent/guardian report	Mean family expressiveness score	post-intervention (1 week after program conclusion)
Secondary	Family expressiveness, parent/guardian report	Mean family expressiveness score	follow-up (6 months after program conclusion)
Secondary	Lakota cultural socialization, parent/guardian report	Mean Lakota cultural socialization score	baseline (1 week before program start)
Secondary	Lakota cultural socialization, parent/guardian report	Mean Lakota cultural socialization score	post-intervention (1 week after program conclusion)
Secondary	Lakota cultural socialization, parent/guardian report	Mean Lakota cultural socialization score	follow-up (6 months after program conclusion)
Secondary	Lakota parenting practices	Mean Lakota parenting practices score	baseline (1 week before program start)
Secondary	Lakota parenting practices	Mean Lakota parenting practices score	post-intervention (1 week after program conclusion)
Secondary	Lakota parenting practices	Mean Lakota parenting practices score	follow-up (6 months after program conclusion)
Secondary	Knowledge of Lakota kinship terminology	Count of correct Lakota kinship terms	baseline (1 week before program start)
Secondary	Knowledge of Lakota kinship terminology	Count of correct Lakota kinship terms	post-intervention (1 week after program conclusion)
Secondary	Knowledge of Lakota kinship terminology	Count of correct Lakota kinship terms	follow-up (6 months after program conclusion)
Secondary	Parent lifetime alcohol use	Lifetime prevalence of alcohol use	baseline (1 week before program start)
Secondary	Parent lifetime alcohol use	Lifetime prevalence of alcohol use	post-intervention (1 week after program conclusion)
Secondary	Parent lifetime alcohol use	Lifetime prevalence of alcohol use	follow-up (6 months after program conclusion)
Secondary	Parent past month alcohol use	Mean frequency of past month alcohol use	baseline (1 week before program start)
Secondary	Parent past month alcohol use	Mean frequency of past month alcohol use	post-intervention (1 week after program conclusion)
Secondary	Parent past month alcohol use	Mean frequency of past month alcohol use	follow-up (6 months after program conclusion)
Secondary	Parent past month alcohol use quantity	Mean usual quantity of past month alcohol consumption	baseline (1 week before program start)
Secondary	Parent past month alcohol use quantity	Mean usual quantity of past month alcohol consumption	post-intervention (1 week after program conclusion)
Secondary	Parent past month alcohol use quantity	Mean usual quantity of past month alcohol consumption	follow-up (6 months after program conclusion)
Secondary	Parent past month alcohol use maximum quantity	Mean maximum quantity of past month alcohol consumption	baseline (1 week before program start)
Secondary	Parent past month alcohol use maximum quantity	Mean maximum quantity of past month alcohol consumption	post-intervention (1 week after program conclusion)
Secondary	Parent past month alcohol use maximum quantity	Mean maximum quantity of past month alcohol consumption	follow-up (6 months after program conclusion)
Secondary	Parent past month alcohol use usual quantity	Mean usual quantity of past month alcohol consumption	baseline (1 week before program start)
Secondary	Parent past month alcohol use usual quantity	Mean usual quantity of past month alcohol consumption	post-intervention (1 week after program conclusion)
Secondary	Parent past month alcohol use usual quantity	Mean usual quantity of past month alcohol consumption	follow-up (6 months after program conclusion)
Secondary	Parent past month alcohol intoxication frequency	Mean frequency of past month alcohol intoxication	baseline (1 week before program start)
Secondary	Parent past month alcohol intoxication frequency	Mean frequency of past month alcohol intoxication	post-intervention (1 week after program conclusion)
Secondary	Parent past month alcohol intoxication frequency	Mean frequency of past month alcohol intoxication	follow-up (6 months after program conclusion)
Secondary	Parent first age of alcohol use	Mean age of first alcohol use	baseline (1 week before program start)
Secondary	Parent first age of alcohol use	Mean age of first alcohol use	post-intervention (1 week after program conclusion)
Secondary	Parent first age of alcohol use	Mean age of first alcohol use	follow-up (6 months after program conclusion)
Secondary	Parent first age of alcohol intoxication	Mean age of first alcohol intoxication	baseline (1 week before program start)
Secondary	Parent first age of alcohol intoxication	Mean age of first alcohol intoxication	post-intervention (1 week after program conclusion)
Secondary	Parent first age of alcohol intoxication	Mean age of first alcohol intoxication	follow-up (6 months after program conclusion)
Secondary	Parent lifetime cigarette use	Lifetime prevalence of cigarette use	baseline (1 week before program start)
Secondary	Parent lifetime cigarette use	Lifetime prevalence of cigarette use	post-intervention (1 week after program conclusion)
Secondary	Parent lifetime cigarette use	Lifetime prevalence of cigarette use	follow-up (6 months after program conclusion)
Secondary	Parent past month cigarette use	Mean frequency and quantity of past month cigarette use	baseline (1 week before program start)
Secondary	Parent past month cigarette use	Mean frequency and quantity of past month cigarette use	post-intervention (1 week after program conclusion)
Secondary	Parent past month cigarette use	Mean frequency and quantity of past month cigarette use	follow-up (6 months after program conclusion)
Secondary	Parent age of first cigarette use	Mean age of first cigarette use	baseline (1 week before program start)
Secondary	Parent age of first cigarette use	Mean age of first cigarette use	post-intervention (1 week after program conclusion)
Secondary	Parent age of first cigarette use	Mean age of first cigarette use	follow-up (6 months after program conclusion)
Secondary	Parent lifetime smokeless tobacco use	Lifetime prevalence of smokeless tobacco use	baseline (1 week before program start)
Secondary	Parent lifetime smokeless tobacco use	Lifetime prevalence of smokeless tobacco use	post-intervention (1 week after program conclusion)
Secondary	Parent lifetime smokeless tobacco use	Lifetime prevalence of smokeless tobacco use	follow-up (6 months after program conclusion)
Secondary	Parent past month smokeless tobacco use	Mean frequency and quantity of past month smokeless tobacco use	baseline (1 week before program start)
Secondary	Parent past month smokeless tobacco use	Mean frequency and quantity of past month smokeless tobacco use	post-intervention (1 week after program conclusion)
Secondary	Parent past month smokeless tobacco use	Mean frequency and quantity of past month smokeless tobacco use	follow-up (6 months after program conclusion)
Secondary	Parent age of first smokeless tobacco use	Mean age of first smokeless tobacco use	baseline (1 week before program start)
Secondary	Parent age of first smokeless tobacco use	Mean age of first smokeless tobacco use	post-intervention (1 week after program conclusion)
Secondary	Parent age of first smokeless tobacco use	Mean age of first smokeless tobacco use	follow-up (6 months after program conclusion)
Secondary	Parent lifetime e-cigarette use	Lifetime prevalence of e-cigarette use	baseline (1 week before program start)
Secondary	Parent lifetime e-cigarette use	Lifetime prevalence of e-cigarette use	post-intervention (1 week after program conclusion)
Secondary	Parent lifetime e-cigarette use	Lifetime prevalence of e-cigarette use	follow-up (6 months after program conclusion)
Secondary	Parent frequency of past-month e-cigarette use	Mean frequency of past month e-cigarette use	baseline (1 week before program start)
Secondary	Parent frequency of past-month e-cigarette use	Mean frequency of past month e-cigarette use	post-intervention (1 week after program conclusion)
Secondary	Parent frequency of past-month e-cigarette use	Mean frequency of past month e-cigarette use	follow-up (6 months after program conclusion)
Secondary	Parent lifetime marijuana use	Lifetime prevalence of marijuana use	baseline (1 week before program start)
Secondary	Parent lifetime marijuana use	Lifetime prevalence of marijuana use	post-intervention (1 week after program conclusion)
Secondary	Parent lifetime marijuana use	Lifetime prevalence of marijuana use	follow-up (6 months after program conclusion)
Secondary	Parent past-month marijuana use	Mean frequency of past month marijuana use	baseline (1 week before program start)
Secondary	Parent past-month marijuana use	Mean frequency of past month marijuana use	post-intervention (1 week after program conclusion)
Secondary	Parent past-month marijuana use	Mean frequency of past month marijuana use	follow-up (6 months after program conclusion)
Secondary	Parent age of first marijuana use	Mean age of first marijuana use	baseline (1 week before program start)
Secondary	Parent age of first marijuana use	Mean age of first marijuana use	post-intervention (1 week after program conclusion)
Secondary	Parent age of first marijuana use	Mean age of first marijuana use	follow-up (6 months after program conclusion)
Secondary	Parent lifetime huffing	Lifetime prevalence of huffing/inhalant use	baseline (1 week before program start)
Secondary	Parent lifetime huffing	Lifetime prevalence of huffing/inhalant use	post-intervention (1 week after program conclusion)
Secondary	Parent lifetime huffing	Lifetime prevalence of huffing/inhalant use	follow-up (6 months after program conclusion)
Secondary	Parent past month huffing	Mean frequency of past month huffing/inhalant use	baseline (1 week before program start)
Secondary	Parent past month huffing	Mean frequency of past month huffing/inhalant use	post-intervention (1 week after program conclusion)
Secondary	Parent past month huffing	Mean frequency of past month huffing/inhalant use	follow-up (6 months after program conclusion)
Secondary	Parent age of first huffing	Mean age of first huffing/inhalant use	baseline (1 week before program start)
Secondary	Parent age of first huffing	Mean age of first huffing/inhalant use	post-intervention (1 week after program conclusion)
Secondary	Parent age of first huffing	Mean age of first huffing/inhalant use	follow-up (6 months after program conclusion)
Secondary	Parent lifetime use of non-prescription painkillers	Lifetime prevalence of non-prescription painkiller use	baseline (1 week before program start)
Secondary	Parent lifetime use of non-prescription painkillers	Lifetime prevalence of non-prescription painkiller use	post-intervention (1 week after program conclusion
Secondary	Parent lifetime use of non-prescription painkillers	Lifetime prevalence of non-prescription painkiller use	follow-up (6 months after program conclusion)
Secondary	Parent past month non-prescription painkiller use	Mean frequency of past month non-prescription painkiller use	baseline (1 week before program start)
Secondary	Parent past month non-prescription painkiller use	Mean frequency of past month non-prescription painkiller use	post-intervention (1 week after program conclusion)
Secondary	Parent past month non-prescription painkiller use	Mean frequency of past month non-prescription painkiller use	follow-up (6 months after program conclusion)
Secondary	Parent lifetime stimulant use	Lifetime prevalence of stimulant use	baseline (1 week before program start)
Secondary	Parent lifetime stimulant use	Lifetime prevalence of stimulant use	post-intervention (1 week after program conclusion)
Secondary	Parent lifetime stimulant use	Lifetime prevalence of stimulant use	follow-up (6 months after program conclusion)
Secondary	Parent past month stimulant use	Mean frequency of past month huffing/inhalant use	baseline (1 week before program start)
Secondary	Parent past month stimulant use	Mean frequency of past month huffing/inhalant use	post-intervention (1 week after program conclusion)
Secondary	Parent past month stimulant use	Mean frequency of past month huffing/inhalant use	follow-up (6 months after program conclusion)
Secondary	Parent lifetime sedative use	Lifetime prevalence of sedative use	baseline (1 week before program start)
Secondary	Parent lifetime sedative use	Lifetime prevalence of sedative use	post-intervention (1 week after program conclusion)
Secondary	Parent lifetime sedative use	Lifetime prevalence of sedative use	follow-up (6 months after program conclusion)
Secondary	Parent past month sedative use	Mean frequency of past month sedative use	baseline (1 week before program start)
Secondary	Parent past month sedative use	Mean frequency of past month sedative use	post-intervention (1 week after program conclusion)
Secondary	Parent past month sedative use	Mean frequency of past month sedative use	follow-up (6 months after program conclusion)
Secondary	Parent lifetime heroin use	Lifetime prevalence of heroin use	baseline (1 week before program start)
Secondary	Parent lifetime heroin use	Lifetime prevalence of heroin use	post-intervention (1 week after program conclusion)
Secondary	Parent lifetime heroin use	Lifetime prevalence of heroin use	follow-up (6 months after program conclusion)
Secondary	Parent past month heroin use	Mean frequency of past month heroin use	baseline (1 week before program start)
Secondary	Parent past month heroin use	Mean frequency of past month heroin use	post-intervention (1 week after program conclusion)
Secondary	Parent past month heroin use	Mean frequency of past month heroin use	follow-up (6 months after program conclusion)
Secondary	Parent lifetime methamphetamine use	Lifetime prevalence of methamphetamine use	baseline (1 week before program start)
Secondary	Parent lifetime methamphetamine use	Lifetime prevalence of methamphetamine use	post-intervention (1 week after program conclusion)
Secondary	Parent lifetime methamphetamine use	Lifetime prevalence of methamphetamine use	follow-up (6 months after program conclusion)
Secondary	Parent past month methamphetamine use	Mean frequency of past month methamphetamine use	baseline (1 week before program start)
Secondary	Parent past month methamphetamine use	Mean frequency of past month methamphetamine use	post-intervention (1 week after program conclusion)
Secondary	Parent past month methamphetamine use	Mean frequency of past month methamphetamine use	follow-up (6 months after program conclusion)
Secondary	Parent lifetime hallucinogen use	Lifetime prevalence of hallucinogen use	baseline (1 week before program start)
Secondary	Parent lifetime hallucinogen use	Lifetime prevalence of hallucinogen use	post-intervention (1 week after program conclusion)
Secondary	Parent lifetime hallucinogen use	Lifetime prevalence of hallucinogen use	follow-up (6 months after program conclusion)
Secondary	Parent past month hallucinogen use	Mean frequency of past month hallucinogen use	baseline (1 week before program start)
Secondary	Parent past month hallucinogen use	Mean frequency of past month hallucinogen use	post-intervention (1 week after program conclusion)
Secondary	Parent past month hallucinogen use	Mean frequency of past month hallucinogen use	follow-up (6 months after program conclusion)
Secondary	Parent lifetime club drug use	Lifetime prevalence of club drug use	baseline (1 week before program start)
Secondary	Parent lifetime club drug use	Lifetime prevalence of club drug use	post-intervention (1 week after program conclusion)
Secondary	Parent lifetime club drug use	Lifetime prevalence of club drug use	follow-up (6 months after program conclusion)
Secondary	Parent past month club drug use	Mean frequency of past month club drug use	baseline (1 week before program start)
Secondary	Parent past month club drug use	Mean frequency of past month club drug use	post-intervention (1 week after program conclusion)
Secondary	Parent past month club drug use	Mean frequency of past month club drug use	follow-up (6 months after program conclusion)
Secondary	Parent lifetime cocaine/crack use	Lifetime prevalence of cocaine/crack use	baseline (1 week before program start)
Secondary	Parent lifetime cocaine/crack use	Lifetime prevalence of cocaine/crack use	post-intervention (1 week after program conclusion)
Secondary	Parent lifetime cocaine/crack use	Lifetime prevalence of cocaine/crack use	follow-up (6 months after program conclusion)
Secondary	Parent past month cocaine/crack use	Mean frequency of past month cocaine/crack use	baseline (1 week before program start)
Secondary	Parent past month cocaine/crack use	Mean frequency of past month cocaine/crack use	follow-up (6 months after program conclusion)
Secondary	Parent HIV risk behavior	Lifetime prevalence of HIV risk behavior	baseline (1 week before program start)
Secondary	Parent HIV risk behavior	Lifetime prevalence of HIV risk behavior	post-intervention (1 week after program conclusion)
Secondary	Parent HIV risk behavior	Lifetime prevalence of HIV risk behavior	follow-up (6 months after program conclusion)
Secondary	Parent psychological distress	Mean psychological distress score	baseline (1 week before program start)
Secondary	Parent psychological distress	Mean psychological distress score	post-intervention (1 week after program conclusion)
Secondary	Parent psychological distress	Mean psychological distress score	follow-up (6 months after program conclusion)
Secondary	Parent life satisfaction	Mean life satisfaction score	baseline (1 week before program start)
Secondary	Parent life satisfaction	Mean life satisfaction score	post-intervention (1 week after program conclusion)
Secondary	Parent life satisfaction	Mean life satisfaction score	follow-up (6 months after program conclusion)