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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02383225
Other study ID # 12-1641
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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)
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