Clinical trial NCT02383225: Culturally Grounded Early Substance Use Prevention for American Indian Families
Official title: Culturally Grounded Early Substance Use Prevention for American Indian Families
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use
Keywords: American Indian
Adolescent
Prevention
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2015-03-09
Enrollment: 449
Sex: ALL
Minimum age (years): 10
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Youth lifetime alcohol use
timeFrame: Baseline (1 week before program start)
measure: Youth lifetime alcohol use
timeFrame: Post-intervention (1 week after program conclusion)
measure: Youth lifetime alcohol use
timeFrame: Follow-up (6 months after program conclusion)
measure: Youth past-month alcohol use
timeFrame: Baseline (1 week before program start)
measure: Youth past-month alcohol use
timeFrame: Post-intervention (1 week after program conclusion)
measure: Youth past-month alcohol use
timeFrame: Follow-up (6 months after program conclusion)
measure: Youth maximum alcohol use in past month
timeFrame: Baseline (1 week before program start)
measure: Youth maximum alcohol use in past month
timeFrame: Post-intervention (1 week after program conclusion)
measure: Youth maximum alcohol use in past month
timeFrame: Follow-up (6 months after program conclusion)
measure: Youth age of first alcohol use
timeFrame: Baseline (1 week before program start)
measure: Youth age of first alcohol use
timeFrame: Post-intervention (1 week after program conclusion)
measure: Youth age of first alcohol use
timeFrame: Follow-up (6 months after program conclusion)
measure: Youth lifetime cigarette use
timeFrame: Baseline (1 week before program start)
measure: Youth lifetime cigarette use
timeFrame: Post-intervention (1 week after program conclusion)
measure: Youth lifetime cigarette use
timeFrame: Follow-up (6 months after program conclusion)
measure: Youth past-month cigarette use
timeFrame: Baseline (1 week before program start)
measure: Youth past-month cigarette use
timeFrame: Post-intervention (1 week after program conclusion)
measure: Youth past-month cigarette use
timeFrame: Follow-up (6 months after program conclusion)
measure: Youth age of first cigarette use
timeFrame: Baseline (1 week before program start)
measure: Youth age of first cigarette use
timeFrame: Post-intervention (1 week after program conclusion)
measure: Youth age of first cigarette use
timeFrame: Follow-up (6 months after program conclusion)
measure: Youth prevalence of smokeless tobacco use
timeFrame: Baseline (1 week before program start)
measure: Youth prevalence of smokeless tobacco use
timeFrame: Post-intervention (1 week after program conclusion)
measure: Youth prevalence of smokeless tobacco use
timeFrame: Follow-up (6 months after program conclusion)
measure: Youth frequency of past-month smokeless tobacco use
timeFrame: Baseline (1 week before program start)
measure: Youth frequency of past-month smokeless tobacco use
timeFrame: Post-intervention (1 week after program conclusion)
measure: Youth frequency of past-month smokeless tobacco use
timeFrame: Follow-up (6 months after program conclusion)
measure: Youth age of first smokeless tobacco use
timeFrame: Baseline (1 week before program start)
measure: Youth age of first smokeless tobacco use
timeFrame: Post-intervention (1 week after program conclusion)
measure: Youth age of first smokeless tobacco use
timeFrame: Follow-up (6 months after program conclusion)
measure: Youth lifetime prevalence of e-cigarette use
timeFrame: Baseline (1 week before program start)
measure: Youth lifetime prevalence of e-cigarette use
timeFrame: Post-intervention (1 week after program conclusion)
measure: Youth lifetime prevalence of e-cigarette use
timeFrame: Follow-up (6 months after program conclusion)
measure: Youth past-month e-cigarette use
timeFrame: Baseline (1 week before program start)
measure: Youth past-month e-cigarette use
timeFrame: Post-intervention (1 week after program conclusion)
measure: Youth past-month e-cigarette use
timeFrame: Follow-up (6 months after program conclusion)
measure: Youth lifetime marijuana use
timeFrame: Baseline (1 week before program start)
measure: Youth lifetime marijuana use
timeFrame: Post-intervention (1 week after program conclusion)
measure: Youth lifetime marijuana use
timeFrame: Follow-up (6 months after program conclusion)
measure: Youth past-month marijuana use
timeFrame: Baseline (1 week before program start)
measure: Youth past-month marijuana use
timeFrame: Post-intervention (1 week after program conclusion)
measure: Youth past-month marijuana use
timeFrame: Follow-up (6 months after program conclusion)
measure: Youth age of first marijuana use
timeFrame: Baseline (1 week before program start)
measure: Youth age of first marijuana use
timeFrame: Post-intervention (1 week after program conclusion)
measure: Youth age of first marijuana use
timeFrame: Follow-up (6 months after program conclusion)
measure: Youth lifetime prevalence of huffing glue/gas
timeFrame: Baseline (1 week before program start)
measure: Youth lifetime prevalence of huffing glue/gas
timeFrame: Post-intervention (1 week after program conclusion)
measure: Youth lifetime prevalence of huffing glue/gas
timeFrame: Follow-up (6 months after program conclusion)
measure: Youth past-month huffing
timeFrame: Baseline (1 week before program start)
measure: Youth past-month huffing
timeFrame: Post-intervention (1 week after program conclusion)
measure: Youth past-month huffing
timeFrame: Follow-up (6 months after program conclusion)
measure: Youth age of first huffing
timeFrame: Baseline (1 week before program start)
measure: Youth age of first huffing
timeFrame: Post-intervention (1 week after program conclusion)
measure: Youth age of first huffing
timeFrame: Follow-up (6 months after program conclusion)
Secondary outcomes:
measure: Youth perceived consistency of parental discipline practices
timeFrame: baseline (1 week before program start)
measure: Youth perceived consistency of parental discipline practices
timeFrame: post-intervention (1 week after program conclusion)
measure: Youth perceived consistency of parental discipline practices
timeFrame: follow-up (6 months after program conclusion)
measure: Youth perceived parental standard setting
timeFrame: baseline (1 week before program start)
measure: Youth perceived parental standard setting
timeFrame: post-intervention (1 week after program conclusion)
measure: Youth perceived parental standard setting
timeFrame: follow-up (6 months after program conclusion)
measure: Youth perceived parental monitoring
timeFrame: baseline (1 week before program start)
measure: Youth perceived parental monitoring
timeFrame: post-intervention (1 week after program conclusion)
measure: Youth perceived parental monitoring
timeFrame: follow-up (6 months after program conclusion)
measure: Youth perceived parental positive affect
timeFrame: baseline (1 week before program start)
measure: Youth perceived parental positive affect
timeFrame: post-intervention (1 week after program conclusion)
measure: Youth perceived parental positive affect
timeFrame: follow-up (6 months after program conclusion)
measure: Youth perceived parental approval
timeFrame: baseline (1 week before program start)
measure: Youth perceived parental approval
timeFrame: post-intervention (1 week after program conclusion)
measure: Youth perceived parental approval
timeFrame: follow-up (6 months after program conclusion)
measure: Youth perceived parental negative affect
timeFrame: baseline (1 week before program start)
measure: Youth perceived parental negative affect
timeFrame: post-intervention (1 week after program conclusion)
measure: Youth perceived parental negative affect
timeFrame: follow-up (6 months after program conclusion)
measure: Youth perceived parent-child communication
timeFrame: baseline (1 week before program start)
measure: Youth perceived parent-child communication
timeFrame: post-intervention (1 week after program conclusion)
measure: Youth perceived parent-child communication
timeFrame: follow-up (6 months after program conclusion)
measure: Youth perceived parent-child communication about alcohol and drugs
timeFrame: baseline (1 week before program start)
measure: Youth perceived parent-child communication about alcohol and drugs
timeFrame: post-intervention (1 week after program conclusion)
measure: Youth perceived parent-child communication about alcohol and drugs
timeFrame: follow-up (6 months after program conclusion)
measure: Youth perceived enforcement of family rules
timeFrame: baseline (1 week before program start)
measure: Youth perceived enforcement of family rules
timeFrame: post-intervention (1 week after program conclusion); follow-up (6 months after program conclusion)
measure: Youth perceived enforcement of family rules
timeFrame: follow-up (6 months after program conclusion)
measure: Youth perceived parental autonomy support
timeFrame: baseline (1 week before program start)
measure: Youth perceived parental autonomy support
timeFrame: post-intervention (1 week after program conclusion); follow-up (6 months after program conclusion)
measure: Youth perceived parental autonomy support
timeFrame: follow-up (6 months after program conclusion)
measure: Parent-child shared activities - youth report
timeFrame: baseline (1 week before program start)
measure: Parent-child shared activities - youth report
timeFrame: post-intervention (1 week after program conclusion)
measure: Parent-child shared activities - youth report
timeFrame: follow-up (6 months after program conclusion)
measure: Family cohesion - youth report
timeFrame: baseline (1 week before program start)
measure: Family cohesion - youth report
timeFrame: post-intervention (1 week after program conclusion)
measure: Family cohesion - youth report
timeFrame: follow-up (6 months after program conclusion)
measure: Family conflict resolution - youth report
timeFrame: baseline (1 week before program start)
measure: Family conflict resolution - youth report
timeFrame: post-intervention (1 week after program conclusion)
measure: Family conflict resolution - youth report
timeFrame: follow-up (6 months after program conclusion)
measure: Family expressiveness - youth report
timeFrame: baseline (1 week before program start)
measure: Family expressiveness - youth report
timeFrame: post-intervention (1 week after program conclusion)
measure: Family expressiveness - youth report
timeFrame: follow-up (6 months after program conclusion)
measure: Lakota cultural socialization - youth report
timeFrame: baseline (1 week before program start)
measure: Lakota cultural socialization - youth report
timeFrame: post-intervention (1 week after program conclusion)
measure: Lakota cultural socialization - youth report
timeFrame: follow-up (6 months after program conclusion)
measure: Youth perceived parental disapproval of alcohol, tobacco, and marijuana
timeFrame: baseline (1 week before program start)
measure: Youth perceived parental disapproval of alcohol, tobacco, and marijuana
timeFrame: post-intervention (1 week after program conclusion)
measure: Youth perceived parental disapproval of alcohol, tobacco, and marijuana
timeFrame: follow-up (6 months after program conclusion)
measure: Descriptive norms for alcohol, tobacco, and marijuana - youth report
timeFrame: baseline (1 week before program start)
measure: Descriptive norms for alcohol, tobacco, and marijuana - youth report
timeFrame: post-intervention (1 week after program conclusion)
measure: Descriptive norms for alcohol, tobacco, and marijuana - youth report
timeFrame: follow-up (6 months after program conclusion)
measure: Youth antisocial behavior
timeFrame: baseline (1 week before program start)
measure: Youth antisocial behavior
timeFrame: post-intervention (1 week after program conclusion)
measure: Youth antisocial behavior
timeFrame: follow-up (6 months after program conclusion)
measure: Youth prosocial behavior
timeFrame: baseline (1 week before program start)
measure: Youth prosocial behavior
timeFrame: post-intervention (1 week after program conclusion)
measure: Youth prosocial behavior
timeFrame: follow-up (6 months after program conclusion)
measure: Youth deviant peer influences
timeFrame: baseline (1 week before program start)
measure: Youth deviant peer influences
timeFrame: post-intervention (1 week after program conclusion)
measure: Youth deviant peer influences
timeFrame: follow-up (6 months after program conclusion)
measure: Youth prosocial peer influences
timeFrame: baseline (1 week before program start)
measure: Youth prosocial peer influences
timeFrame: post-intervention (1 week after program conclusion)
measure: Youth prosocial peer influences
timeFrame: follow-up (6 months after program conclusion)
measure: Youth peer resistance skills
timeFrame: baseline (1 week before program start)
measure: Youth peer resistance skills
timeFrame: post-intervention (1 week after program conclusion)
measure: Youth peer resistance skills
timeFrame: follow-up (6 months after program conclusion)
measure: Youth lifetime history of stressful life events
timeFrame: baseline (1 week before program start)
measure: Youth lifetime history of stressful life events
timeFrame: post-intervention (1 week after program conclusion)
measure: Youth lifetime history of stressful life events
timeFrame: follow-up (6 months after program conclusion)
measure: Youth stress management skills
timeFrame: baseline (1 week before program start)
measure: Youth stress management skills
timeFrame: post-intervention (1 week after program conclusion)
measure: Youth stress management skills
timeFrame: follow-up (6 months after program conclusion)
measure: Youth psychological well-being
timeFrame: baseline (1 week before program start)
measure: Youth psychological well-being
timeFrame: post-intervention (1 week after program conclusion)
measure: Youth psychological well-being
timeFrame: follow-up (6 months after program conclusion)
measure: Youth knowledge of Lakota kinship terminology
timeFrame: baseline (1 week before program start)
measure: Youth knowledge of Lakota kinship terminology
timeFrame: post-intervention (1 week after program conclusion)
measure: Youth knowledge of Lakota kinship terminology
timeFrame: follow-up (6 months after program conclusion)
measure: Youth self-esteem
timeFrame: baseline (1 week before program start)
measure: Youth self-esteem
timeFrame: post-intervention (1 week after program conclusion)
measure: Youth self-esteem
timeFrame: follow-up (6 months after program conclusion)
measure: General parent-child communication - parent/guardian report
timeFrame: baseline (1 week before program start)
measure: General parent-child communication - parent/guardian report
timeFrame: post-intervention (1 week after program conclusion)
measure: General parent-child communication - parent/guardian report
timeFrame: follow-up (6 months after program conclusion)
measure: Parent-child communication about family issues - parent/guardian report
timeFrame: baseline (1 week before program start)
measure: Parent-child communication about family issues - parent/guardian report
timeFrame: post-intervention (1 week after program conclusion)
measure: Parent-child communication about family issues - parent/guardian report
timeFrame: follow-up (6 months after program conclusion)
measure: Parent-child communication about alcohol and drugs - parent/guardian report
timeFrame: baseline (1 week before program start)
measure: Parent-child communication about alcohol and drugs - parent/guardian report
timeFrame: post-intervention (1 week after program conclusion)
measure: Parent-child communication about alcohol and drugs - parent/guardian report
timeFrame: follow-up (6 months after program conclusion)
measure: Parent/guardian report of youth behavior
timeFrame: baseline (1 week before program start)
measure: Parent/guardian report of youth behavior
timeFrame: post-intervention (1 week after program conclusion)
measure: Parent/guardian report of youth behavior
timeFrame: follow-up (6 months after program conclusion)
measure: Parent/guardian report parent-child shared activities
timeFrame: baseline (1 week before program start)
measure: Parent/guardian report parent-child shared activities
timeFrame: post-intervention (1 week after program conclusion)
measure: Parent/guardian report parent-child shared activities
timeFrame: follow-up (6 months after program conclusion)
measure: Parental monitoring - parent/guardian report
timeFrame: baseline (1 week before program start)
measure: Parental monitoring - parent/guardian report
timeFrame: post-intervention (1 week after program conclusion)
measure: Parental monitoring - parent/guardian report
timeFrame: follow-up (6 months after program conclusion)
measure: General family rules - parent/guardian report
timeFrame: baseline (1 week before program start)
measure: General family rules - parent/guardian report
timeFrame: post-intervention (1 week after program conclusion)
measure: General family rules - parent/guardian report
timeFrame: follow-up (6 months after program conclusion)
measure: Family rules about substance use - parent/guardian report
timeFrame: baseline (1 week before program start)
measure: Family rules about substance use - parent/guardian report
timeFrame: post-intervention (1 week after program conclusion)
measure: Family rules about substance use - parent/guardian report
timeFrame: follow-up (6 months after program conclusion)
measure: Parent discipline practices
timeFrame: baseline (1 week before program start)
measure: Parent discipline practices
timeFrame: post-intervention (1 week after program conclusion)
measure: Parent discipline practices
timeFrame: follow-up (6 months after program conclusion)
measure: Other household member discipline practices
timeFrame: baseline (1 week before program start)
measure: Other household member discipline practices
timeFrame: post-intervention (1 week after program conclusion)
measure: Other household member discipline practices
timeFrame: follow-up (6 months after program conclusion)
measure: Standard setting
timeFrame: baseline (1 week before program start)
measure: Standard setting
timeFrame: post-intervention (1 week after program conclusion)
measure: Standard setting
timeFrame: follow-up (6 months after program conclusion)
measure: Parent-child conflict, parent/guardian report
timeFrame: baseline (1 week before program start)
measure: Parent-child conflict, parent/guardian report
timeFrame: post-intervention (1 week after program conclusion)
measure: Parent-child conflict, parent/guardian report
timeFrame: follow-up (6 months after program conclusion)
measure: Parent support, parent/guardian report
timeFrame: baseline (1 week before program start)
measure: Parent support, parent/guardian report
timeFrame: post-intervention (1 week after program conclusion)
measure: Parent support, parent/guardian report
timeFrame: follow-up (6 months after program conclusion)
measure: Parental positive affect, parent/guardian report
timeFrame: baseline (1 week before program start)
measure: Parental positive affect, parent/guardian report
timeFrame: post-intervention (1 week after program conclusion)
measure: Parental positive affect, parent/guardian report
timeFrame: follow-up (6 months after program conclusion)
measure: Parental negative affect, parent/guardian report
timeFrame: baseline (1 week before program start)
measure: Parental negative affect, parent/guardian report
timeFrame: post-intervention (1 week after program conclusion)
measure: Parental negative affect, parent/guardian report
timeFrame: follow-up (6 months after program conclusion)
measure: Parental anger management, parent/guardian report
timeFrame: baseline (1 week before program start)
measure: Parental anger management, parent/guardian report
timeFrame: post-intervention (1 week after program conclusion)
measure: Parental anger management, parent/guardian report
timeFrame: follow-up (6 months after program conclusion)
measure: Parental self-efficacy
timeFrame: baseline (1 week before program start)
measure: Parental self-efficacy
timeFrame: post-intervention (1 week after program conclusion)
measure: Parental self-efficacy
timeFrame: follow-up (6 months after program conclusion)
measure: Family meetings, parent/guardian report
timeFrame: baseline (1 week before program start)
measure: Family meetings, parent/guardian report
timeFrame: post-intervention (1 week after program conclusion)
measure: Family meetings, parent/guardian report
timeFrame: follow-up (6 months after program conclusion)
measure: Family cohesion, parent/guardian report
timeFrame: baseline (1 week before program start)
measure: Family cohesion, parent/guardian report
timeFrame: post-intervention (1 week after program conclusion
measure: Family cohesion, parent/guardian report
timeFrame: follow-up (6 months after program conclusion)
measure: Family conflict resolution, parent/guardian report
timeFrame: baseline (1 week before program start)
measure: Family conflict resolution, parent/guardian report
timeFrame: post-intervention (1 week after program conclusion)
measure: Family conflict resolution, parent/guardian report
timeFrame: follow-up (6 months after program conclusion)
measure: Family expressiveness, parent/guardian report
timeFrame: baseline (1 week before program start)
measure: Family expressiveness, parent/guardian report
timeFrame: post-intervention (1 week after program conclusion)
measure: Family expressiveness, parent/guardian report
timeFrame: follow-up (6 months after program conclusion)
measure: Lakota cultural socialization, parent/guardian report
timeFrame: baseline (1 week before program start)
measure: Lakota cultural socialization, parent/guardian report
timeFrame: post-intervention (1 week after program conclusion)
measure: Lakota cultural socialization, parent/guardian report
timeFrame: follow-up (6 months after program conclusion)
measure: Lakota parenting practices
timeFrame: baseline (1 week before program start)
measure: Lakota parenting practices
timeFrame: post-intervention (1 week after program conclusion)
measure: Lakota parenting practices
timeFrame: follow-up (6 months after program conclusion)
measure: Knowledge of Lakota kinship terminology
timeFrame: baseline (1 week before program start)
measure: Knowledge of Lakota kinship terminology
timeFrame: post-intervention (1 week after program conclusion)
measure: Knowledge of Lakota kinship terminology
timeFrame: follow-up (6 months after program conclusion)
measure: Parent lifetime alcohol use
timeFrame: baseline (1 week before program start)
measure: Parent lifetime alcohol use
timeFrame: post-intervention (1 week after program conclusion)
measure: Parent lifetime alcohol use
timeFrame: follow-up (6 months after program conclusion)
measure: Parent past month alcohol use
timeFrame: baseline (1 week before program start)
measure: Parent past month alcohol use
timeFrame: post-intervention (1 week after program conclusion)
measure: Parent past month alcohol use
timeFrame: follow-up (6 months after program conclusion)
measure: Parent past month alcohol use quantity
timeFrame: baseline (1 week before program start)
measure: Parent past month alcohol use quantity
timeFrame: post-intervention (1 week after program conclusion)
measure: Parent past month alcohol use quantity
timeFrame: follow-up (6 months after program conclusion)
measure: Parent past month alcohol use maximum quantity
timeFrame: baseline (1 week before program start)
measure: Parent past month alcohol use maximum quantity
timeFrame: post-intervention (1 week after program conclusion)
measure: Parent past month alcohol use maximum quantity
timeFrame: follow-up (6 months after program conclusion)
measure: Parent past month alcohol use usual quantity
timeFrame: baseline (1 week before program start)
measure: Parent past month alcohol use usual quantity
timeFrame: post-intervention (1 week after program conclusion)
measure: Parent past month alcohol use usual quantity
timeFrame: follow-up (6 months after program conclusion)
measure: Parent past month alcohol intoxication frequency
timeFrame: baseline (1 week before program start)
measure: Parent past month alcohol intoxication frequency
timeFrame: post-intervention (1 week after program conclusion)
measure: Parent past month alcohol intoxication frequency
timeFrame: follow-up (6 months after program conclusion)
measure: Parent first age of alcohol use
timeFrame: baseline (1 week before program start)
measure: Parent first age of alcohol use
timeFrame: post-intervention (1 week after program conclusion)
measure: Parent first age of alcohol use
timeFrame: follow-up (6 months after program conclusion)
measure: Parent first age of alcohol intoxication
timeFrame: baseline (1 week before program start)
measure: Parent first age of alcohol intoxication
timeFrame: post-intervention (1 week after program conclusion)
measure: Parent first age of alcohol intoxication
timeFrame: follow-up (6 months after program conclusion)
measure: Parent lifetime cigarette use
timeFrame: baseline (1 week before program start)
measure: Parent lifetime cigarette use
timeFrame: post-intervention (1 week after program conclusion)
measure: Parent lifetime cigarette use
timeFrame: follow-up (6 months after program conclusion)
measure: Parent past month cigarette use
timeFrame: baseline (1 week before program start)
measure: Parent past month cigarette use
timeFrame: post-intervention (1 week after program conclusion)
measure: Parent past month cigarette use
timeFrame: follow-up (6 months after program conclusion)
measure: Parent age of first cigarette use
timeFrame: baseline (1 week before program start)
measure: Parent age of first cigarette use
timeFrame: post-intervention (1 week after program conclusion)
measure: Parent age of first cigarette use
timeFrame: follow-up (6 months after program conclusion)
measure: Parent lifetime smokeless tobacco use
timeFrame: baseline (1 week before program start)
measure: Parent lifetime smokeless tobacco use
timeFrame: post-intervention (1 week after program conclusion)
measure: Parent lifetime smokeless tobacco use
timeFrame: follow-up (6 months after program conclusion)
measure: Parent past month smokeless tobacco use
timeFrame: baseline (1 week before program start)
measure: Parent past month smokeless tobacco use
timeFrame: post-intervention (1 week after program conclusion)
measure: Parent past month smokeless tobacco use
timeFrame: follow-up (6 months after program conclusion)
measure: Parent age of first smokeless tobacco use
timeFrame: baseline (1 week before program start)
measure: Parent age of first smokeless tobacco use
timeFrame: post-intervention (1 week after program conclusion)
measure: Parent age of first smokeless tobacco use
timeFrame: follow-up (6 months after program conclusion)
measure: Parent lifetime e-cigarette use
timeFrame: baseline (1 week before program start)
measure: Parent lifetime e-cigarette use
timeFrame: post-intervention (1 week after program conclusion)
measure: Parent lifetime e-cigarette use
timeFrame: follow-up (6 months after program conclusion)
measure: Parent frequency of past-month e-cigarette use
timeFrame: baseline (1 week before program start)
measure: Parent frequency of past-month e-cigarette use
timeFrame: post-intervention (1 week after program conclusion)
measure: Parent frequency of past-month e-cigarette use
timeFrame: follow-up (6 months after program conclusion)
measure: Parent lifetime marijuana use
timeFrame: baseline (1 week before program start)
measure: Parent lifetime marijuana use
timeFrame: post-intervention (1 week after program conclusion)
measure: Parent lifetime marijuana use
timeFrame: follow-up (6 months after program conclusion)
measure: Parent past-month marijuana use
timeFrame: baseline (1 week before program start)
measure: Parent past-month marijuana use
timeFrame: post-intervention (1 week after program conclusion)
measure: Parent past-month marijuana use
timeFrame: follow-up (6 months after program conclusion)
measure: Parent age of first marijuana use
timeFrame: baseline (1 week before program start)
measure: Parent age of first marijuana use
timeFrame: post-intervention (1 week after program conclusion)
measure: Parent age of first marijuana use
timeFrame: follow-up (6 months after program conclusion)
measure: Parent lifetime huffing
timeFrame: baseline (1 week before program start)
measure: Parent lifetime huffing
timeFrame: post-intervention (1 week after program conclusion)
measure: Parent lifetime huffing
timeFrame: follow-up (6 months after program conclusion)
measure: Parent past month huffing
timeFrame: baseline (1 week before program start)
measure: Parent past month huffing
timeFrame: post-intervention (1 week after program conclusion)
measure: Parent past month huffing
timeFrame: follow-up (6 months after program conclusion)
measure: Parent age of first huffing
timeFrame: baseline (1 week before program start)
measure: Parent age of first huffing
timeFrame: post-intervention (1 week after program conclusion)
measure: Parent age of first huffing
timeFrame: follow-up (6 months after program conclusion)
measure: Parent lifetime use of non-prescription painkillers
timeFrame: baseline (1 week before program start)
measure: Parent lifetime use of non-prescription painkillers
timeFrame: post-intervention (1 week after program conclusion
measure: Parent lifetime use of non-prescription painkillers
timeFrame: follow-up (6 months after program conclusion)
measure: Parent past month non-prescription painkiller use
timeFrame: baseline (1 week before program start)
measure: Parent past month non-prescription painkiller use
timeFrame: post-intervention (1 week after program conclusion)
measure: Parent past month non-prescription painkiller use
timeFrame: follow-up (6 months after program conclusion)
measure: Parent lifetime stimulant use
timeFrame: baseline (1 week before program start)
measure: Parent lifetime stimulant use
timeFrame: post-intervention (1 week after program conclusion)
measure: Parent lifetime stimulant use
timeFrame: follow-up (6 months after program conclusion)
measure: Parent past month stimulant use
timeFrame: baseline (1 week before program start)
measure: Parent past month stimulant use
timeFrame: post-intervention (1 week after program conclusion)
measure: Parent past month stimulant use
timeFrame: follow-up (6 months after program conclusion)
measure: Parent lifetime sedative use
timeFrame: baseline (1 week before program start)
measure: Parent lifetime sedative use
timeFrame: post-intervention (1 week after program conclusion)
measure: Parent lifetime sedative use
timeFrame: follow-up (6 months after program conclusion)
measure: Parent past month sedative use
timeFrame: baseline (1 week before program start)
measure: Parent past month sedative use
timeFrame: post-intervention (1 week after program conclusion)
measure: Parent past month sedative use
timeFrame: follow-up (6 months after program conclusion)
measure: Parent lifetime heroin use
timeFrame: baseline (1 week before program start)
measure: Parent lifetime heroin use
timeFrame: post-intervention (1 week after program conclusion)
measure: Parent lifetime heroin use
timeFrame: follow-up (6 months after program conclusion)
measure: Parent past month heroin use
timeFrame: baseline (1 week before program start)
measure: Parent past month heroin use
timeFrame: post-intervention (1 week after program conclusion)
measure: Parent past month heroin use
timeFrame: follow-up (6 months after program conclusion)
measure: Parent lifetime methamphetamine use
timeFrame: baseline (1 week before program start)
measure: Parent lifetime methamphetamine use
timeFrame: post-intervention (1 week after program conclusion)
measure: Parent lifetime methamphetamine use
timeFrame: follow-up (6 months after program conclusion)
measure: Parent past month methamphetamine use
timeFrame: baseline (1 week before program start)
measure: Parent past month methamphetamine use
timeFrame: post-intervention (1 week after program conclusion)
measure: Parent past month methamphetamine use
timeFrame: follow-up (6 months after program conclusion)
measure: Parent lifetime hallucinogen use
timeFrame: baseline (1 week before program start)
measure: Parent lifetime hallucinogen use
timeFrame: post-intervention (1 week after program conclusion)
measure: Parent lifetime hallucinogen use
timeFrame: follow-up (6 months after program conclusion)
measure: Parent past month hallucinogen use
timeFrame: baseline (1 week before program start)
measure: Parent past month hallucinogen use
timeFrame: post-intervention (1 week after program conclusion)
measure: Parent past month hallucinogen use
timeFrame: follow-up (6 months after program conclusion)
measure: Parent lifetime club drug use
timeFrame: baseline (1 week before program start)
measure: Parent lifetime club drug use
timeFrame: post-intervention (1 week after program conclusion)
measure: Parent lifetime club drug use
timeFrame: follow-up (6 months after program conclusion)
measure: Parent past month club drug use
timeFrame: baseline (1 week before program start)
measure: Parent past month club drug use
timeFrame: post-intervention (1 week after program conclusion)
measure: Parent past month club drug use
timeFrame: follow-up (6 months after program conclusion)
measure: Parent lifetime cocaine/crack use
timeFrame: baseline (1 week before program start)
measure: Parent lifetime cocaine/crack use
timeFrame: post-intervention (1 week after program conclusion)
measure: Parent lifetime cocaine/crack use
timeFrame: follow-up (6 months after program conclusion)
measure: Parent past month cocaine/crack use
timeFrame: baseline (1 week before program start)
measure: Parent past month cocaine/crack use
timeFrame: follow-up (6 months after program conclusion)
measure: Parent HIV risk behavior
timeFrame: baseline (1 week before program start)
measure: Parent HIV risk behavior
timeFrame: post-intervention (1 week after program conclusion)
measure: Parent HIV risk behavior
timeFrame: follow-up (6 months after program conclusion)
measure: Parent psychological distress
timeFrame: baseline (1 week before program start)
measure: Parent psychological distress
timeFrame: post-intervention (1 week after program conclusion)
measure: Parent psychological distress
timeFrame: follow-up (6 months after program conclusion)
measure: Parent life satisfaction
timeFrame: baseline (1 week before program start)
measure: Parent life satisfaction
timeFrame: post-intervention (1 week after program conclusion)
measure: Parent life satisfaction
timeFrame: follow-up (6 months after program conclusion)
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Nancy R Whitesell, PhD
role: PRINCIPAL_INVESTIGATOR
References: