Culturally Grounded Early Substance Use Prevention for American Indian Families

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.

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.