Culturally Grounded Early Substance Use Prevention for American Indian Families
Condition: Substance Use
MeSH terms: Substance-Related Disorders
Study type: Interventional

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.
    

Intervention name(s): Lakota Language enhancement; Facebook Supplement; Substance Use Resistance Skills
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): 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.; 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.; 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).
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: American Indian; Adolescent; Prevention