Substance Use
Conditions
Keywords
American Indian, Adolescent, 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.
Interventions
BEHAVIORALLakota 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.
BEHAVIORALFacebook 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.
BEHAVIORALSubstance 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).
Sponsors
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
10 Years to 85 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Youth lifetime alcohol use | Baseline (1 week before program start) | Lifetime prevalence of alcohol use |
| Youth past-month alcohol use | Baseline (1 week before program start) | Mean frequency of past month alcohol use |
| Youth maximum alcohol use in past month | Baseline (1 week before program start) | Mean maximum quantity of past month alcohol consumption |
| Youth age of first alcohol use | Baseline (1 week before program start) | Mean age of first alcohol use |
| Youth lifetime cigarette use | Baseline (1 week before program start) | Lifetime prevalence of cigarette use |
| Youth past-month cigarette use | Baseline (1 week before program start) | Mean frequency of past month cigarette use |
| Youth lifetime prevalence of e-cigarette use | Baseline (1 week before program start) | Lifetime prevalence of e-cigarette use |
| Youth age of first cigarette use | Baseline (1 week before program start) | Mean age of first cigarette use |
| Youth prevalence of smokeless tobacco use | Baseline (1 week before program start) | Lifetime prevalence of smokeless tobacco use |
| Youth frequency of past-month smokeless tobacco use | Baseline (1 week before program start) | Mean frequency of past month smokeless tobacco use |
| Youth age of first smokeless tobacco use | Baseline (1 week before program start) | Mean age of first smokeless tobacco use |
| Youth past-month e-cigarette use | Baseline (1 week before program start) | Mean frequency of past month e-cigarette use |
| Youth lifetime marijuana use | Baseline (1 week before program start) | Lifetime prevalence of marijuana use |
| Youth past-month marijuana use | Baseline (1 week before program start) | Mean frequency of past month marijuana use |
| Youth age of first marijuana use | Baseline (1 week before program start) | Mean age of first marijuana use |
| Youth lifetime prevalence of huffing glue/gas | Baseline (1 week before program start) | Lifetime prevalence of huffing |
| Youth past-month huffing | Baseline (1 week before program start) | Mean frequency of past month huffing |
| Youth age of first huffing | Baseline (1 week before program start) | Mean age of first huffing |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Family expressiveness - youth report | baseline (1 week before program start) | Mean family expressiveness score |
| Lakota cultural socialization - youth report | baseline (1 week before program start) | Mean Lakota cultural socialization score |
| Youth perceived parental disapproval of alcohol, tobacco, and marijuana | baseline (1 week before program start) | Mean disapproval of alcohol, tobacco, and marijuana score |
| Parent-child communication about family issues - parent/guardian report | baseline (1 week before program start) | Mean general parent-child communication about family issues score |
| Family rules about substance use - parent/guardian report | baseline (1 week before program start) | Mean substance use rules score |
| Parent-child communication about alcohol and drugs - parent/guardian report | baseline (1 week before program start) | Mean parent-child communication about alcohol and drugs score |
| Descriptive norms for alcohol, tobacco, and marijuana - youth report | baseline (1 week before program start) | Mean descriptive norms for alcohol, tobacco, and marijuana score |
| Youth antisocial behavior | baseline (1 week before program start) | Mean antisocial behavior score |
| Parent/guardian report of youth behavior | baseline (1 week before program start) | Mean youth behavior score |
| Youth prosocial behavior | baseline (1 week before program start) | Mean prosocial behavior score |
| Youth deviant peer influences | baseline (1 week before program start) | Mean deviant peer influences score |
| Youth prosocial peer influences | baseline (1 week before program start) | Mean prosocial peer influences score |
| Youth peer resistance skills | baseline (1 week before program start) | Mean peer resistance skills score |
| Youth lifetime history of stressful life events | baseline (1 week before program start) | Count of stressful events |
| Parent/guardian report parent-child shared activities | baseline (1 week before program start) | Count of shared activities |
| Youth stress management skills | baseline (1 week before program start) | Mean stress management skills score |
| Youth psychological well-being | baseline (1 week before program start) | Mean psychological well-being score |
| Youth knowledge of Lakota kinship terminology | baseline (1 week before program start) | Count of correct Lakota kinship terms |
| Youth self-esteem | baseline (1 week before program start) | Mean self-esteem score |
| General parent-child communication - parent/guardian report | baseline (1 week before program start) | Mean general parent-child communication score |
| Other household member discipline practices | baseline (1 week before program start) | Mean other household member discipline practices score |
| Standard setting | baseline (1 week before program start) | Mean standard setting score |
| Parent-child conflict, parent/guardian report | baseline (1 week before program start) | Mean parent-child conflict score |
| Parent support, parent/guardian report | baseline (1 week before program start) | Mean parent support score |
| Parental positive affect, parent/guardian report | baseline (1 week before program start) | Mean parental positive affect score |
| Parental negative affect, parent/guardian report | baseline (1 week before program start) | Mean parental negative affect score |
| Parental anger management, parent/guardian report | baseline (1 week before program start) | Mean parental anger management score |
| Parental self-efficacy | baseline (1 week before program start) | Mean parental self-efficacy |
| Family meetings, parent/guardian report | baseline (1 week before program start) | Mean family meetings score |
| Family cohesion, parent/guardian report | baseline (1 week before program start) | Mean family cohesion score |
| Family conflict resolution, parent/guardian report | baseline (1 week before program start) | Mean family conflict resolution score |
| Family expressiveness, parent/guardian report | baseline (1 week before program start) | Mean family expressiveness score |
| Lakota cultural socialization, parent/guardian report | baseline (1 week before program start) | Mean Lakota cultural socialization score |
| Lakota parenting practices | baseline (1 week before program start) | Mean Lakota parenting practices score |
| Knowledge of Lakota kinship terminology | baseline (1 week before program start) | Count of correct Lakota kinship terms |
| Parent past month alcohol use quantity | baseline (1 week before program start) | Mean usual quantity of past month alcohol consumption |
| Parent past month alcohol use maximum quantity | baseline (1 week before program start) | Mean maximum quantity of past month alcohol consumption |
| Parent past month alcohol use usual quantity | baseline (1 week before program start) | Mean usual quantity of past month alcohol consumption |
| Parent past month alcohol intoxication frequency | baseline (1 week before program start) | Mean frequency of past month alcohol intoxication |
| Parent first age of alcohol use | baseline (1 week before program start) | Mean age of first alcohol use |
| Parent first age of alcohol intoxication | baseline (1 week before program start) | Mean age of first alcohol intoxication |
| Parent lifetime cigarette use | baseline (1 week before program start) | Lifetime prevalence of cigarette use |
| Parent past month cigarette use | baseline (1 week before program start) | Mean frequency and quantity of past month cigarette use |
| Parent age of first cigarette use | baseline (1 week before program start) | Mean age of first cigarette use |
| Parent lifetime smokeless tobacco use | baseline (1 week before program start) | Lifetime prevalence of smokeless tobacco use |
| Parent past month smokeless tobacco use | baseline (1 week before program start) | Mean frequency and quantity of past month smokeless tobacco use |
| Parent age of first smokeless tobacco use | baseline (1 week before program start) | Mean age of first smokeless tobacco use |
| Parent lifetime e-cigarette use | baseline (1 week before program start) | Lifetime prevalence of e-cigarette use |
| Parent frequency of past-month e-cigarette use | baseline (1 week before program start) | Mean frequency of past month e-cigarette use |
| Parent lifetime marijuana use | baseline (1 week before program start) | Lifetime prevalence of marijuana use |
| Parent discipline practices | baseline (1 week before program start) | Mean parent discipline practices score |
| Parent age of first marijuana use | baseline (1 week before program start) | Mean age of first marijuana use |
| Parent lifetime huffing | baseline (1 week before program start) | Lifetime prevalence of huffing/inhalant use |
| Parent past month huffing | baseline (1 week before program start) | Mean frequency of past month huffing/inhalant use |
| Parent age of first huffing | baseline (1 week before program start) | Mean age of first huffing/inhalant use |
| Parent lifetime use of non-prescription painkillers | baseline (1 week before program start) | Lifetime prevalence of non-prescription painkiller use |
| Parent past month non-prescription painkiller use | baseline (1 week before program start) | Mean frequency of past month non-prescription painkiller use |
| Parent lifetime stimulant use | baseline (1 week before program start) | Lifetime prevalence of stimulant use |
| Parent lifetime hallucinogen use | baseline (1 week before program start) | Lifetime prevalence of hallucinogen use |
| Parent past month stimulant use | baseline (1 week before program start) | Mean frequency of past month huffing/inhalant use |
| Parent lifetime sedative use | baseline (1 week before program start) | Lifetime prevalence of sedative use |
| Parent past month sedative use | baseline (1 week before program start) | Mean frequency of past month sedative use |
| Parent lifetime heroin use | baseline (1 week before program start) | Lifetime prevalence of heroin use |
| Parent past month heroin use | baseline (1 week before program start) | Mean frequency of past month heroin use |
| Parent lifetime methamphetamine use | baseline (1 week before program start) | Lifetime prevalence of methamphetamine use |
| Parent past month methamphetamine use | baseline (1 week before program start) | Mean frequency of past month methamphetamine use |
| Parent past month hallucinogen use | baseline (1 week before program start) | Mean frequency of past month hallucinogen use |
| Parent lifetime club drug use | baseline (1 week before program start) | Lifetime prevalence of club drug use |
| Parent past month club drug use | baseline (1 week before program start) | Mean frequency of past month club drug use |
| Parent lifetime cocaine/crack use | baseline (1 week before program start) | Lifetime prevalence of cocaine/crack use |
| Parent past month cocaine/crack use | baseline (1 week before program start) | Mean frequency of past month cocaine/crack use |
| Parent HIV risk behavior | baseline (1 week before program start) | Lifetime prevalence of HIV risk behavior |
| Parent psychological distress | baseline (1 week before program start) | Mean psychological distress score |
| Parent life satisfaction | baseline (1 week before program start) | Mean life satisfaction score |
| Parent past-month marijuana use | baseline (1 week before program start) | Mean frequency of past month marijuana use |
| Parent lifetime alcohol use | baseline (1 week before program start) | Lifetime prevalence of alcohol use |
| Parent past month alcohol use | baseline (1 week before program start) | Mean frequency of past month alcohol use |
| Parental monitoring - parent/guardian report | baseline (1 week before program start) | Mean parental monitoring score |
| General family rules - parent/guardian report | baseline (1 week before program start) | Mean family rules score |
| Youth perceived consistency of parental discipline practices | baseline (1 week before program start) | Mean perceived consistency of parental discipline practices score |
| Youth perceived parental standard setting | baseline (1 week before program start) | Mean perceived parental standard setting score |
| Youth perceived parental monitoring | baseline (1 week before program start) | Mean perceived parental monitoring score |
| Youth perceived parental positive affect | baseline (1 week before program start) | Mean perceived parental positive affect score |
| Youth perceived parental approval | baseline (1 week before program start) | Mean perceived parental approval score |
| Youth perceived parental negative affect | baseline (1 week before program start) | Mean perceived parental negative affect score |
| Youth perceived parent-child communication | baseline (1 week before program start) | Mean perceived parent-child communication score |
| Youth perceived parent-child communication about alcohol and drugs | baseline (1 week before program start) | Mean perceived parent-child communication about alcohol and drugs score |
| Youth perceived enforcement of family rules | baseline (1 week before program start) | Mean perceived enforcement of family rules score |
| Youth perceived parental autonomy support | baseline (1 week before program start) | Mean perceived parental autonomy support score |
| Parent-child shared activities - youth report | baseline (1 week before program start) | Count of parent-child shared activities |
| Family cohesion - youth report | baseline (1 week before program start) | Mean family cohesion score |
| Family conflict resolution - youth report | baseline (1 week before program start) | Mean family conflict resolution score |
Countries
United States
Outcome results
None listed