Prevention Trial in the Cherokee Nation: Design of a Randomized Community Trial

Abstract

Despite advances in prevention science and practice in recent decades, the U.S. continues to struggle with significant alcohol-related risks and consequences among youth, especially among vulnerable rural and Native American youth. The Prevention Trial in the Cherokee Nation is a partnership between prevention scientists and Cherokee Nation Behavioral Health to create, implement, and evaluate a new, integrated community-level intervention designed to prevent underage drinking and associated negative consequences among Native American and other youth living in rural high-risk underserved communities. The intervention builds directly on results of multiple previous trials of two conceptually distinct approaches. The first is an updated version of CMCA, an established community environmental change intervention, and the second is CONNECT, our newly developed population-wide intervention based on screening, brief intervention, and referral to treatment (SBIRT) research. CMCA direct-action community organizing is used to engage local citizens to address community norms and practices related to alcohol use and commercial and social access to alcohol among adolescents. The new CONNECT intervention expands traditional SBIRT to be implemented universally within schools. Six key research design elements optimize causal inference and experimental evaluation of intervention effects, including a controlled interrupted time-series design, purposive selection of towns, random assignment to study condition, nested cohorts as well as repeated cross-sectional observations, a factorial design crossing two conceptually distinct interventions, and multiple comparison groups. The purpose of this paper is to describe the strong partnership between prevention scientists and behavioral health leaders within the Cherokee Nation, and the intervention and research design of this new community trial.

Full text

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Prevention Science
ISSN 1389-4986
Volume 16
Number 2
Prev Sci (2015) 16:291-300
DOI 10.1007/s11121-014-0478-y
Prevention Trial in the Cherokee Nation:
Design of a Randomized Community Trial
Kelli A.Komro, Alexander C.Wagenaar,
Misty Boyd, B.J.Boyd, Terrence
Kominsky, Dallas Pettigrew, Amy
L.Tobler, Sarah D.Lynne-Landsman, et
al.

1 23
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Prevention Trial in the Cherokee Nation: Design of a Randomized
Community Trial
Kelli A. Komro &Alexander C. Wagenaar &Misty Boyd &B. J. Boyd &Terrence Kominsky &
Dallas Pettigrew &Amy L. Tobler &Sarah D. Lynne-Landsman &Melvin D. Livingston &
Bethany Livingston &Mildred M. Maldonado Molina
Published online: 11 March 2014
#The Author(s) 2014. This article is published with open access at Springerlink.com
Abstract Despite advances in prevention science and prac-
tice in recent decades, the U.S. continues to struggle with
significant alcohol-related risks and consequences among
youth, especially among vulnerable rural and Native
American youth. The Prevention Trial in the Cherokee
Nation is a partnership between prevention scientists and
Cherokee Nation Behavioral Health to create, implement,
and evaluate a new, integrated community-level intervention
designed to prevent underage drinking and associated nega-
tive consequences among Native American and other youth
living in rural high-risk underserved communities. The inter-
vention builds directly on results of multiple previous trials of
two conceptually distinct approaches. The first is an updated
version of CMCA, an established community environmental
change intervention, and the second is CONNECT, our newly
developed population-wide intervention based on screening,
brief intervention, and referral to treatment (SBIRT) research.
CMCA direct-action community organizing is used to engage
local citizens to address community norms and practices re-
lated to alcohol use and commercial and social access to
alcohol among adolescents. The new CONNECT intervention
expands traditional SBIRT to be implemented universally
within schools. Six key research design elements optimize
causal inference and experimental evaluation of intervention
effects, including a controlled interrupted time-series design,
purposive selection of towns, random assignment to study
condition, nested cohorts as well as repeated cross-sectional
observations, a factorial design crossing two conceptually
distinct interventions, and multiple comparison groups. The
purpose of this paper is to describe the strong partnership
between prevention scientists and behavioral health leaders
within the Cherokee Nation, and the intervention and research
design of this new community trial.
Keywords Alcohol prevention .Native American .Rural .
Community trial .SBIRT .Environment
Prevention Trial in the Cherokee Nation: Design
of a Randomized Community Trial
The American Academy of Pediatrics recently published a
policy statement emphasizing that alcohol use continues to be
a major problem among youth, from preadolescence through
young adulthood, and additional efforts are needed to prevent
and reduce underage drinking (Committee on Substance
Abuse 2010). According to the Youth Risk Behavior Survey
(Centers for Disease Control and Prevention 2010) conducted
within high schools (grades 9–12) across the country, the
proportion of youth who reported any use of alcohol or heavy
episodic use within the past month was 42 % and 24 %,
respectively. Rural youth in general, and rural youth who are
an ethnic minority in their community in particular, are at
increased risk for alcohol use and getting drunk (Swaim and
Stanley 2010). Data from national surveys suggest that Native
American high school students have rates of alcohol use
similar to the majority White population (Substance Abuse
and Mental Health Services Administration 2011). Other stud-
ies have documented higher levels of alcohol use (Beauvais
et al. 2004) and higher prevalence of past-year alcohol use
disorders (National Survey on Drug Use and Health 2007)
among Native American youth. Importantly, Native
K. A. Komro (*):A. C. Wagenaar :A. L. Tobler :
S. D. Lynne-Landsman :M. D. Livingston :B. Li vingston :
M. M. M. Molina
Department of Health Outcomes & Policy, College of Medicine and
Institute for Child Health Policy, University of Florida, Gainesville,
FL, USA
e-mail: komro@ufl.edu
M. Boyd :B. J. Boyd :T. K omi nsk y :D. Pettigrew
Cherokee Nation Behavioral Health, Tahlequah, OK, USA
Prev Sci (2015) 16:291–300
DOI 10.1007/s11121-014-0478-y

Americans have suffered disproportionately from the negative
effects of alcohol (Szlemko et al. 2006). Native Americans are
552 % more likely to die from alcoholism, and significantly
more likely to die from unintentional injuries, homicide, and
suicide than other Americans (Indian Health Service 2013).
Early preventive efforts are urgently needed to reduce these
significant health disparities.
Rural communities and Native American populations are
both underrepresented populations in clinical and community
trial research and give rise to particular challenges for dissem-
ination of evidence-based practices. Challenges to the imple-
mentation of evidence-based strategies within rural commu-
nities include (a) distance from major metropolitan areas,
health centers, and universities; (b) potential limitations on
cultural appropriateness, acceptability, and relevance of
established strategies; and (c) limited resources of families
and communities. To address these challenges, the
Prevention Trial in the Cherokee Nation builds on the extant
accumulation of evidence by incorporating evidence-based
strategies that are inherently adaptable to local culture and
incorporating them into an integrated population-level ap-
proach for feasible and widespread implementation and opti-
mal reach throughout the community. Further, our partnership
incorporates a model of community-based participatory re-
search that also adheres to the strict scientific methods of a
controlled trial. This avoids a traditional dichotomy between
these two approaches and creates effective working partner-
ships between academic scientists and their professional peers
working in the field. Our goal is creating, implementing, and
evaluating a new, integrated population-level intervention de-
signed to prevent underage drinking and associated negative
consequences among multicultural youth living in rural high-
risk and underserved communities.
Community-Based Participatory Research Approach
A community-based participatory research (CBPR) approach
and selection of evidence-based strategies that are inherently
adaptable to individual and community characteristics were
envisioned as a way to overcome the three main barriers
(distance from major metropolitan areas, health centers, and
universities; potential limitations on cultural appropriateness;
limited resources of families and communities). CBPR is an
orientation to research that engages academic and community
partners throughout the research process (Israel et al. 1998;
Minkler 2010). Of key principles of community-based re-
search defined by Israel et al. (1998), four are especially
relevant in describing the partnership we have developed for
the implementation of this trial. These key principles include
(a) facilitates collaborative partnerships in all phases of the
research, (b) builds on strengths and resources within the
community, (c) integrates knowledge and action for mutual
benefit of all partners, and (d) promotes a co-learning and
empowering process that attends to social inequalities (Israel
et al. 1998).
Soon after an NIH request for applications was posted for
“multi-component youth/young adult alcohol prevention tri-
als”(RFA-AA-11-001), a team of prevention scientists at the
University of Florida (UF) was exploring options for a com-
munity partner. They were particularly interested in develop-
ing a partnership with a Native American community given
the significant alcohol-related health disparities suffered
among Native Americans. A mutual colleague introduced
the UF team to leaders of Cherokee Nation Behavioral
Health and participated in the initial brainstorming meeting.
The Cherokee Nation (CN) is the second largest Native
American tribe with nearly 300,000 citizens. About half of the
tribal members live within the 14-county jurisdictional service
area of the Cherokee Nation in northeastern Oklahoma. It is
not a reservation. Cherokee citizens comprise a significant
proportion of the population within this 14-county region;
however these are multi-ethnic rural communities with mostly
Native American (10 % to 44 %) and White (44 % to 79 %)
populations. Tahlequah, Oklahoma is the capitol of the
Cherokee Nation and home to the tri-partite government
(i.e., executive, judicial, legislative), which includes a demo-
cratically elected principal chief, deputy principal chief and
17-member tribal council. Governmental services include
housing, community, education, health and human services,
and commerce and career services. The Cherokee Nation
operates the largest tribally operated health care system in
the U.S.A. Within the health system is Cherokee Nation
Behavioral Health, directed by Dr. BJ Boyd, which provides
mental health services, substance abuse treatment, and
community-based programs promoting mental health. Dr. BJ
Boyd, as well as Dr. Misty Boyd, a clinical child psychologist,
serve as the CN Co-PIs of the trial. Substance abuse and
related consequences are major issues faced by the CN be-
havioral health team, and they are committed to early preven-
tion and community-based efforts, as well as providing treat-
ment services.
The University of Florida prevention science team has over
a 20-year history of conducting community-based prevention
trials focused on multiple populations from small, largely
White rural communities, to African-American and Hispanic
urban populations; from children and adolescents to young
adults; and studies of U.S. populations complemented by
collaborative global work over the years in Australia,
Britain, India, Japan, New Zealand, Norway, Russia, and
Tanzania (Komro et al. 2008,2004;2001; Wagenaar et al.
2000a). The trials that have included community-level envi-
ronmental change have incorporated a community-driven or-
ganizing approach to lead that change.
During our initial in-person meeting in Tahlequah, it was
clear to both teams that this was a mutually beneficial
292 Prev Sci (2015) 16:291–300

collaboration. We spent an intense and energetic 2 days together
learning about each others’values and passion for child health
promotion, as well as productively outlining major plans for the
grant proposal, including research and intervention designs.
Eachteamhadtocommittothepartnershipandsuccessful
implementation of the trial. For the CN team, it meant commit-
ting to additional effort (e.g., community outreach, project
supervision, learning new research skills) above and beyond
an already hectic schedule. For the UF team, it meant commit-
ting to frequent travel, research mentorship, and equality in the
partnership. We have structured the project to be co-led by the
UF PI (KK) and the CN Co-PIs (MB, BB). However, it is a
democratically run project with full participation of all UF and
CN team members. We hold multiple weekly conference calls
where we debate and make decisions together. In addition to the
core project team (UF and CN), we have multiple community
partners that also have key roles in specific components of the
project including (a) school district superintendents, high
school principals, and teachers; (b) Oklahoma Department of
Human Services local supervisors and school-based social
workers; and (c) local citizens and community organizations.
The Prevention Trial in the Cherokee Nation is a rigorous
community trial funded by NIH, using methods of translation-
al science by providing infrastructure, training, and technical
assistance to incorporate two evidence-based interventions
into rural and underserved communities and schools. The
implementation of the trial provides an important example of
the development and success of a practitioner–scientist part-
nership. We have followed key steps in developing practition-
er–scientist partnerships as recently outlined (Spoth et al.
2013), including (a) identifying common goals of interest,
(b) community leadership development, (c) incorporating role
flexibility through shared decision-making, (d) careful mea-
surement of change to produce continuous quality improve-
ment, and (e) equality in partnerships and valuing each others
skills and knowledge. The partnership and the integration of
the interventions and their evaluation into the established local
institutional structures of the Cherokee Nation and involved
communities also increases the likelihood of longer-term sus-
tainability following the research trial. The following sections
outline the intervention and research design for the trial that
have been developed and are being implemented through a
strong academic and community partnership.
Intervention Design
The intervention design builds directly on results of multiple
previous experimental research trials with two broad interven-
tion approaches—(a) community environmental change and
(b) screening, brief intervention and referral to treatment
(SBIRT). Major progress has occurred in science and preven-
tion practice in reducing youth access to alcohol through
commercial sources such as bars and stores (Anderson et al.
2009; Wagenaar and Wolfson 1994,1995). As progress has
been made in attenuating commercial access of alcohol to
teens (though much remains to be done in most communities),
the role of informal social sources is gaining increased atten-
tion. Significant challenges remain in understanding how best
to reduce availability of alcohol through social sources, par-
ticularly from (often slightly older) peers. And, importantly,
progress has been less in environments characterized by high
alcohol use, other risk factors, and socioeconomic disadvan-
tage (Anderson et al. 2009; Foxcroft et al. 2002;Hawkins
et al. 2004; Komro et al. 2004).
On an individual level, there is evidence for short-term
reductions in underage alcohol use through SBIRT (Clark
et al. 2010; Clark and Moss 2010; Moore and Werch 2009;
Wachtel and Staniford 2010; Werch et al. 2010,2000). The
SBIRT approach has also been determined effective with other
populations and other risk behaviors, such as heavy alcohol
use, body weight, total blood cholesterol, and blood pressure
among adults (Kaner et al. 2007; Rubak et al. 2005;Whitlock
et al. 2004). The preponderance of previous trials of SBIRT,
however, have been focused on single small- to modest-scale
institutional settings, such as primary care clinics, hospital
emergency departments, or a single or selective set of schools.
No trials to date have tested a population-level intervention
incorporating features of SBIRT found efficacious in the
small-scale or limited institutional settings of previous trials.
In short, challenges remain in understanding how to bring
SBIRT efforts to scale within communities, broaden
population-level relevance and implementation, and sustain
preventive effects over time.
The evidence base for these two strategies led to our design
of a new community intervention strategy that combines
components of strategies at the individual and community
level, with innovations designed to strengthen and enhance
effects. We selected these two approaches for implementation
within our multi-ethnic, rural communities since they are both
adaptable and responsive strategies to individual and commu-
nity differences. A community organizing approach em-
powers local citizens to create change within their communi-
ties based on their values and needs. SBIRT, implemented
using motivational interviewing, is designed to be responsive
to individual student needs and readiness to change.
We have designed both intervention approaches for all high
school students in the study communities—a universal,
population-level prevention approach. We do not single out
Native American students or families for the interventions.
Available regional and national youth surveys (Centers for
Disease Control and Prevention 2010) indicate alcohol use
preventive efforts are warranted for youth regardless of their
race/ethnicity. Importantly, singling out Native American
youth contributes to stigmatization and isolation of Native
American youth. Through the partnership between Cherokee
Prev Sci (2015) 16:291–300 293

Nation Behavioral Health and prevention scientists, as well as
epidemiological and formative research, we have selected
intervention components that are culturally responsive and
relevant, but not culturally limited to one group. The needs
for effective prevention and support are high throughout our
study communities, and our interventions are carefully de-
signed so no group feels excluded. By updating and combin-
ing the most efficacious components from previous research
trials on community environmental change, designing a new
system for universal and school implementation of an SBIRT
intervention, and ensuring cultural relevance, the current trial
is designed to advance preventive effectiveness and efficiency
in high-need, underserved and multi-ethnic communities.
Theoretical Framework
Wagenaar and Perry’s(1994) comprehensive theoretical
framework of drinking behavior guided development of our
integrated universal preventive intervention, as shown in
Fig. 1. We designed a community intervention that builds
directly on the original Communities Mobilizing for Change
on Alcohol (CMCA) trial and subsequent disseminated model
intervention (Wagenaar et al. 2000a; Wagenaar et al. 2000b;
Wolf s o n e t a l. 2012) with additional evidence-based compo-
nents. The environmental interventions in the current trial are
community-driven and focus on decreasing physical
availability and increasing formal social controls on
both access to and consumption of alcohol by youth.
Intervention features are hypothesized to affect per-
ceived and observed access to alcohol by youth, per-
ceptions of enforcement, drinking norms, drinking be-
haviors, and alcohol-related risks and outcomes.
We also designed a universal implementation of SBIRT,
integrating key components from youth-focused strategies
(Clark et al. 2010; Clark and Moss 2010; Moore and Werch
2009; Wachtel and Staniford 2010; Werch et al. 2010,2000),
while expanding relevance and reach with components
from effective alcohol and suicide prevention strategies
(Isaac et al. 2009; Perry et al. 2000b; Wyman et al.
2008). The expanded SBIRT intervention, CONNECT,
will focus on promoting screening with brief intervention
using motivational interviewing, positive social interactions
and role models, and social and multicultural competencies.
The CONNECT intervention is designed to affect alcohol
cognitions, expectancies, social support and bonding, drink-
ing models and norms, drinking behaviors and alcohol-related
risks, in addition to serving the conventional role of SBIRT in
identifying and nudging especially high-risk individuals into
more intensive treatment.
Environmental Intervention: CMCA
Direct-action community organizing, documented as effective
in multiple previous trials, is used to address community
Legal Availability
Drinking age 21
Hours of sale
No service to intoxicated
Enforcement
Formal Social Controls
Size of threat, reward
Probability of detection
Probability of threat/reward
application
Speed of application
Economic Availability
Retail price of alcohol
Search and acquisition costs
Physical Availability
Quantity accessible
Geographic density of
outlets/access points
Proximity to outlets/access
points
Point of purchase displays
Decrease noncommercial
access
Biological/Pharmacological
Genetic predisposition/family
history
Dependence/tolerance
General Beliefs/Perceptions/Personality
Emotionality
Locus of control
Self-esteem
Depression
Impulsivity
Drinking Behavior
Quantity/frequency
Riskiness of drinking
Alcohol Cognitions/
Perceptions
Expectancies
Meanings
Positive Social Interactions
Family: parents/siblings/
extended
Peers
School and community
gatekeepers
Role Models
Family: parents/sibings/
extended
Peers
School and community
gatekeepers
Media
Access
Perceived access
Observed access
Environmental Interventions Brief Interventions
Moderators
Primary Outcomes
Additive/Synergystic
Effect
Proximal Outcomes Proximal Outcomes
Drinking Norms
Cultural
Community
Youth/peer
Social/Cultural Disadvantage
Poverty and poor social conditions
Forced acculturation, cultural
disruption
Discrimination
Social/Cultural Competencies
Social competencies
Bicultural competence
Drinking Norms
Cultural
Community
Youth/peer
Enforcement
Perceptions
Detection
Penalties/rewards
Alcohol-related Risks/
Harms
Academic
Social
Other risk behaviors
Injuries
Social Support
Cultural Dimensions of Drinking
Euroamerican
Cherokee
Rural subculture
Youth subculture
SBIRT
Nurse/prevention specialist
School and community
gatekeepers
Referral to school/
community resources
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Fig. 1 Theoretical framework for the Prevention Trial in the Cherokee Nation
294 Prev Sci (2015) 16:291–300

identified issues related to alcohol use and access to alcohol
among youth. Action teams were formed in each intervention
community, assisted by a community organizer trained in com-
munity organizing methods such as those used in D.A.R.E.
Plus, Project Northland Chicago, Tobacco Policy Options for
Prevention, and CMCA randomized trials (Forster et al. 1998;
Komro et al. 2008; Perry et al. 2000a; Wagenaar et al. 2000a,b;
Wagenaar and Perry 1994). Goals of the environmental inter-
ventions include the following: (a) reduce the number of alcohol
outlets that sell to young people; (b) reduce the availability of
alcohol to youth from noncommercial sources, such as parents,
siblings, older peers, and via kegs and/or at parties; (c) reduce
community tolerance of underage drinking and adult provision
of alcohol to youth; and (d) ultimately, reduce youth alcohol
consumption and alcohol-related problems. The primary,
evidence-based intervention, CMCA (Wagenaar et al. 2000a,
b; Wagenaar and Perry 1994),hasbeenenhancedbyincorpo-
rating the latest evidence regarding enforcement checks, hot-
spot policing, and the role of earned and paid media.
A local community organizer was hired in each CMCA
intervention community. Following local advertisement, we
screened the applicant pool and members of the CN team (MB
and DP) conducted in-person interviews. Final candidates
were interviewed by the UF PI (KK) via phone. We conducted
an initial 3-day training led by CN (MB, DP) and UF (KK,
AW, SL, BL) team members, as well as a nationally recog-
nized alcohol prevention community organizer (Diane Riibe).
A member of the CN team (DP) serves as the Intervention
Director and supervises all intervention staff. He, along with
the CN Co-PI (MB), hold weekly calls with the organizers and
conduct regular site visits. Members of the UF team (KK, AW,
SL) participate in the calls every other week. The calls include
review and guided feedback based on process documentation
completed weekly by the organizers and their oral summary of
progress. Formal, in-person booster trainings and strategizing
sessions are held in Tahlequah four times each year with
members of the CN and UF teams.
A community organizing model was selected as an optimal
way to engage a diverse group of local citizens in these multi-
cultural towns. Shared values surrounding the protection and
promotion of youth well-being and the recognition of alcohol
use as a major risk is a motivating factor for many citizens that
have committed their time to join their local community action
team. Five key principles guide our organizing approach,
including (a) empowerment and leadership development of
local citizens, (b) reliance on relationship building, (c) mobi-
lization and action of local citizens, (d) community determi-
nation of strategies and community ownership, and (e) inten-
tional use of evidence-based strategies for sustainable com-
munity change.
We defined six main stages of community organizing and
provide guided feedback to the community organizers as they
work with their community action teams. The six stages
include (a) assessment of community interests through face-
to-face, one-on-one or two-on-one meetings with hundreds of
community residents; (b) building a base of support through
one-on-ones and establishment of a community action team;
(c) expanding the base of support through one- or two-on-one
meetings, presence and presentations at community events,
and media advocacy; (d) development of a plan of action; (e)
implementation of actions; and (f) maintenance of effort and
institutionalization of change. These six stages are an iterative
process, in that they are fluid with movement between and
across stages and are meant to be responsive to community
needs and capabilities. The UF and CN team provide training
and technical assistance in principles of community organiz-
ing and on evidence-based prevention strategies. On an ongo-
ing basis, we provide evidence-based fact sheets and action
guides that address community needs around reducing under-
age access to alcohol through commercial and social sources.
Action teams meet monthly to discuss community needs,
strategize and select appropriate actions, and plan events and
actions. All one-on-ones, action team meetings, team actions,
and media are documented weekly using standardized forms
(described below in the “Implementation Evaluation”
subsection).
SBIRT Intervention: CONNECT
The CONNECT intervention includes four key components:
(a) twice a year brief one-on-one screening and motivational
interviewing sessions delivered to every high school student
in the study cohort (class of 2015 and 2016) by a “CONNECT
Coach,”(b) training of school staff to reinforce risk identifi-
cation and communication and support skills, (c) training of
community members, and (d) family and community media
campaign to reinforce intervention objectives. Goals of
CONNECT are to increase bonding, social support and inclu-
sion, and to shift towards more protective alcohol cognitions
and norms among high school students and the general
population.
Given the challenge of low health care access and utiliza-
tion among high school students, and the fact that only a small
proportion of high school students see a physician or visit a
clinic in a given year, we designed the SBIRT intervention to
be delivered in schools. We partnered with the Oklahoma
Department of Human Services (OKDHS) to provide a full-
time school social worker in each CONNECT intervention
high school. The CN team along with the local school super-
intendent and/or principal participated in the interview and
hiring process. The school social workers devote 49 % FTE
effort to serving as the school’s CONNECT Coach for this
trial and the other 51 % FTE they serve as a liaison linking
students and their families to relevant community services,
which strengthens the partnership between the schools and the
OKDHS and enhances sustainability.
Prev Sci (2015) 16:291–300 295

The Coaches conduct brief (15 min) one-on-one health
consultations in a private school office with each student once
each semester (mean number of cohort students per school is
300, range 262 to 369). Coaches communicate with the school
principals to work out a mutually agreed upon plan for sched-
uling sessions. Teachers and students are notified of each
scheduled appointment via email or an appointment card.
Students are excused from class for their 15-min session. Our
implementation of SBIRT is based on NIAAA’sAlcohol
Screening and Brief Intervention for Youth: A Practitioner’s
Guide guidelines (NIAAA 2011). The brief session includes
advice, motivational interviewing, norm-setting messages and
referral for follow-up support or specialty treatment, including a
brief follow-up session for those referred.
The CN Intervention Director (DP) supervises the project
effort by reviewing the Coaches’standardized weekly reports,
holding weekly phone meetings, regular site visits, and com-
munication with school principals and the OKDHS supervisor.
Members of the UF team (KK, BL) and the CN team (MB, BG)
participate in the calls twice a month and conduct regular site
visits. Coaches were provided an initial 3-day training and two
yearly booster trainings (scheduled at the beginning of fall and
spring semesters). Training and feedback include guidance in
implementation of SBIRT, motivational interviewing tech-
niques, and cultural sensitivity training with special emphasis
on motivational interviewing with Native Americans.
To support and expand reach of the SBIRT intervention,
additional school and community members involved with youth
are provided Connector training to enhance their connections
and communication with youth, identify signs of high risk, and
refer youth to school and community resources, if needed. This
aspect of the intervention serves to enhance school personnel and
community member competency in communicating with ado-
lescents about alcohol and other important decisions, which aids
in sustainability of any positive effects. Postcards with behavioral
tips (Komro et al. 2008; Perry et al. 2003, Perry et al. 2002)are
mailed quarterly to high school students’primary residence, as
well as posters distributed throughout the community and placed
in commonly frequented venues such as restaurants, grocery
stores and churches. Topics of the campaign are selected from
scientifically established risk and protective factors for adolescent
alcohol use and include (a) communication and connection, (b)
monitoring, (c) identification of high-risk behaviors and commu-
nity resources, (d) risks associated with alcohol use among youth,
and (e) family rules.
Research Design
Study Design
Implementation and evaluation of complex community-based
interventions requires careful selection of multiple design
elements to optimize causal inference. We have designed this
study to rigorously evaluate effects of the community-wide
intervention on the primary ultimate outcomes of alcohol use,
misuse and alcohol-related problems, while also remaining
within strict limitations on study resources. In addition to an
overall estimate of intervention effect, the trial must evaluate
effects of each major intervention strategy (here CMCA and
CONNECT) on intermediate (or proximal) outcomes. As one
example, the CONNECT intervention will target alcohol ex-
pectancies and social support, while the environmental inter-
vention will target commercial and social access to alcohol. To
achieve even these proximal outcomes, it is necessary to
measure whether interventions are implemented with fidelity
and the extent to which target audiences are being effectively
reached. To address these questions we also include in the
study design a rigorous assessment of intervention
implementation.
Six key design elements optimize causal inference and
experimental evaluation of the intervention (Kratochwill and
Levin 2010; Shadish et al. 2002). As shown in Table 1,we
have combined a controlled interrupted time-series design,
purposive selection of towns, random assignment to study
condition, nested cohorts as well as repeated cross-sectional
observations, a factorial design crossing two conceptually
distinct interventions, and multiple comparison groups.
The large number of repeated measures (a time-series)
substantially increases internal validity (i.e., strength of causal
inference) as well as statistical power over conventional pre/
post community trial designs. One of our previous community
trials clearly established the feasibility and high level of infer-
ential utility of such time-series designs (Wagenaar et al.
2005). The study sample will include a cohort of high-
school students within study towns (class of 2015 and
2016). Quarterly measurements of students via a school-
based survey and monthly assessments of alcohol purchase
attempts across all study treatment and control sites produce a
time-series design with observations of youth and alcohol
outlets nested within town over a 4-year period (there is one
high school per town). In addition to repeated cross-sectional
samples of youth, we will use participant identifiers to track
the embedded cohorts over 4 years. Quarterly and monthly
measurements will provide powerful tools to examine func-
tional relations between the introduction and ramp-up of in-
terventions and relevant outcomes over time.
Towns were purposively selected and randomly assigned to
study condition. Of the rural towns within the 14-county
Cherokee Nation tribal jurisdiction area that have high
schools, 12 met the study selection criteria, which included:
(a) served by one mid-sized high school with 400–700 stu-
dents (which means that the high school student population is
socially integrated into the town); (b) at least a 30-mile sepa-
ration from the next town (to limit the threat of contamination
across study conditions; these are socially cohesive
296 Prev Sci (2015) 16:291–300

communities where people tend to stay within a 20-mile
radius of their town and identify strongly with the communi-
ty); and (c) have local businesses, including ones that sell
alcohol (so that local initiatives could target commercial
sources of alcohol). We constructed a risk score for each town
based on school and town characteristics obtained from school
and census records, as well as the Youth Risk Behavior
Survey, and selected four of the six among the highest risk
communities. These four towns were then randomly assigned
into one of the four study conditions (A–DinTable1). After the
initial three baseline youth surveys were implemented within
the first 9 months of the project, we updated power calculations
with actual data and decided to recruit two additional towns,
allocating one to the combined intervention condition and one
to the control condition to ensure adequate youth sample size
for cohort analyses. These were drawn from the initial list of 12
eligible towns and selected based on proximity to the original
combined and control towns. Therefore, the final sample in-
cludes six towns, two each in the combined and control condi-
tions and one each in the CMCA only and CONNECT only
conditions. The remaining 6 towns will serve as archival con-
trols (condition E in Table 1). Study procedureswereapproved
by both the University of Florida and Cherokee Nation
Institutional Review Boards.
Recruitment
Towns, with their embedded high school, were randomly
assigned to study condition prior to recruitment. Following
randomization to condition, we (UF and CN team leaders)
scheduled recruitment meetings with school district superin-
tendents and high school principals. Information packets spe-
cific to each condition were presented to the school leadership,
as well as a summary of the entire project, and a cooperative
agreement form for them to sign. All six schools agreed to
participate in the study and signed cooperative agreement
forms to participate in the study for 4 years. Response rates
at the individual level (for the five baseline waves of student
surveys) ranged from 82 % to 87 %.
Study Communities, Schools, Participants
The six study towns range in population from 1,423 to 9,300,
with 9 % to 37 % of the town population being Native
American. Median household income ranges from $26,222
to $38,000, below median income levels for Oklahoma
($44,287) and the U.S. ($52,762).
On the study survey, students are able to mark all that apply
for race/ethnicity. Forty-seven percent of cohort students
(school range 40 % to 63 %) indicated they were Native
American, including 23 % who reported being Native
American only, 21 % Native American and White, and 3 %
Native American and another race/ethnicity. Seventy-one per-
cent of the students reported being White (school range 53 %
to 78 %), including 45 % who reported being White only.
Fifty-three percent of students (school range 47 % to 66 %)
reported being eligible for free/reduced price lunch, and the
mean age was 15 overall and for each school.
Data Collection
Youth Surve y Brief (10–15 min) self-report questionnaires are
administered to the study cohort (9th and 10th grade students
during the 2012–13 academic year, class of 2015 and 2016) in
the six study schools four times each year (approximately in
October, December, February, May). The questionnaires are
administered under the direction of the study Evaluation
Director (TK) with a team of locally hired (not from the study
communities) and trained research survey staff following
standardized procedures. In order to maximize student confi-
dentiality, school staff are not involved in survey implemen-
tation. Students receive a $5 incentive for each survey, and an
additional $10 during the fourth administration if they partic-
ipated in all surveys for which they were eligible during the
academic year. Each questionnaire has a unique study ID to
link individual responses over time. Parents are sent a consent
letter 4–6 weeks prior to survey administration and asked to
call a toll-free number or return a postage paid postcard if they
do not want their child to participate. Prior to the consent letter
Tabl e 1 Randomized time-series experimental design for the Prevention Trial in the Cherokee Nation
A. Treatment Town:
(n≈250 youth)
O(M)
ikt1(1)
………O(M)
ikt5(12)
X
CONNECT6(13)–19(54)
O(M)
ikt6(13)
………………..…
19(54)
B. Treatment Town:
(n≈250 youth)
O(M)
ikt1(1)
………O(M)
ikt5(12)
X
CMCA 6(13)–19(54)
O(M)
ikt6(13)
…………..………
19(54)
C. Treatment Towns (n=2):
(n≈500 youth)
O(M)
ikt1(1)
………O(M)
ikt5(12)
X
COMBINED6(13)–19(54)
O(M)
ikt6(13)
……….....……….
19(54)
D. Control Towns (n=2):
(n≈500 youth)
O(M)
ikt1(1)
……………………………..……..…………………….….……..………….O(M)
ikt19(54)
E. Control Towns (n=6):
(n≈250 youth/town)
O(A)
ikt1(1)
………………………..……..…………………….….…………………..…..…O(A)
ikt5(54)
iindividual/person, ktreatment condition, ttime, Oobservation, O(M) monitoring system and archival sources, quarterly (monthly) observations/
measures+archival sources, O(A) archival sources of yearly (monthly) observations/measures
Prev Sci (2015) 16:291–300 297

mailing, we send a postcard informing parents that an important
letter is being mailed to them, and then following the consent
mailing, we send a reminder postcard. Students are given an
assent form and given the opportunity to refuse participation.
Questionnaire items are based on the national Youth Risk
Behavior Survey (YRBS) (Centers for Disease Control and
Prevention 2010), the Oklahoma Prevention Needs
Assessment Survey (OPNA; Oklahoma Department of Mental
Health and Substance Abuse Services 2010), and surveys used
in the Project Northland trials (Komro et al. 2008; Perry et al.
1996). The main outcome of interest is alcohol use, measured
primarily with three standard items from the YRBS, including
frequency of use in one’s lifetime, past 30 days, and 5 or more
drinks of alcohol in a row in the past 30 days. We also included
items on smokeless tobacco, cigarettes, marijuana, prescription
drugs without a doctor’s prescription, and any other illegal drug
(Centers for Disease Control and Prevention 2010).
In Oklahoma high schools, the state department of mental
health and substance abuse services implements the
Oklahoma Prevention Needs Assessment Survey every
even-numbered year and the Youth Risk Behavior Survey
every odd-numbered year. These annual surveys implemented
in the archival control towns will be used as an additional
secondary comparison group. Comparisons will also be made
with state and national trends.
Among 9th and 10th grade students during baseline wave 5
(December 2012; n=1,562), use in the past month was report-
ed by 19 % for alcohol use, 12 % for binge drinking, 10 % for
chewing tobacco use, 15 % for cigarette use, and 9 % for
marijuana use. Alcohol and marijuana use rates among 9th
and 10th graders in the six project schools were slightly lower
than rates reported from the 2011 Oklahoma and U.S. Youth
Risk Behavior Survey.
Alcohol Purchase Attempts The propensity of stores to sell
alcohol to underage youth is measured directly using a proto-
col well-developed in our previous trials (Komro et al. 2008;
Perry et al. 1996; Wagenaar and Perry 1994; Wagenaar et al.
2005), a protocol that is now in widespread use nationally.
Buyers are 21 or older but appear younger than 21 and are
trained to request a standard type of alcohol without identifi-
cation as part of the uniform protocols in making the purchase
attempt. Off-site alcohol outlets in each of the study commu-
nities are assessed once each month. The mean number of
alcohol outlets per town is 21 (range 17 to 25). (Outlets were
included if they were within a 20-min drive time from the
town center.) Buyers are accompanied by another young-
appearing research staff member, both complete data collec-
tion forms following each purchase attempt, and they are
debriefed about their experiences using standardized forms.
The procedure directly assesses how strictly proof-of-age is
adhered to in the intervention and control communities.
Baseline buy rate ranged from 17 % to 32 %.
Archival Data In all 12 study towns, we collect archival data
(e.g., traffic citations, police arrest reports, juvenile justice
system reports, alcohol-related fatal and non-fatal crashes,
teen STIs, teen birth rate, juvenile substance abuse treatment
admissions), including high school records and annual sur-
veys (e.g., absenteeism, suspensions, juvenile offenders, se-
nior graduation rate, 4-year drop out rate, standardized test
scores, annual other alcohol and drug survey data). These data
provide a baseline characterization of the study and compar-
ison towns and enable monitoring of outcomes during the
study and after intervention implementation.
Implementation Evaluation Building on our prior work, we
developed a standardized system to collect implementation
measures daily as a routine part of the field intervention staff
activities. A user-friendly measurement system is not only
vital to an overall evaluation effort; it also functions as a
management information system for field intervention staff
and as a continuous quality improvement system to improve
the implementation and effectiveness of interventions over
time. Field intervention staff electronically access a secure,
password protected encrypted reporting system modeled on
similar systems developed for our previous trials, but en-
hanced with the use of the latest in current easy to use database
software (i.e., Bento) (Komro et al. 2008; Perry et al. 2000a;
Wagenaar et al. 2000a,b; Wagenaar and Perry 1994). In
addition to using the system as an integral tool to facilitate
their daily work tasks, the staff perform a more focused
weekly update followed by securely transferring the week’s
updated data to the research team.
Discussion
This trial contributes to the field of prevention and translation
science with innovative design features, a rigorous evaluation
of a population-level implementation of SBIRTsupplemented
with family and community components, and a replication of
an efficacious environmental change approach within high-
risk, underserved communities with large populations of
Native Americans. The project will provide guidance on the
effectiveness of intervention components alone and in combi-
nation, and advance the understanding of effective strategies
for underage drinking prevention among Native American
youth, as well as high-risk rural youth in general.
The trial also provides a successful example of a true
academic–community partnership in the design and imple-
mentation of a rigorous community randomized trial funded
by NIH. Our CBPR team reflects a close and effective collab-
oration between scientists at the University of Florida, with a
long history of conducting community intervention trials, and
the leadership of Cherokee Nation Behavioral Health, with
strong interests in promoting youth health and advancing
298 Prev Sci (2015) 16:291–300

preventive intervention effectiveness. We, the CN and UF
team, are conducting an NIH-funded community trial with
detailed attention to rigorous scientific methods, at the same
time developing strong connections with local community-
based organizations. We are accessible, communicative, and
responsive to questions, priorities and concerns of our
community-based partners. We are in frequent contact with
the OKDHS and school principals across the Cherokee Nation
as we implement this complex intervention trial. Each year we
also hold more formal meetings with school leadership to
share school-level data from the student surveys and provide
updates on intervention progress. We support our community
action teams with frequent communications, strategic plan-
ning, review of intervention materials, and response to re-
quests for information regarding effective strategies. The ac-
tion teams continue to build additional partnerships with local
citizens and organizations to initiate and sustain community
change. The CONNECT Coaches receive intensive training in
MI, a culturally sensitive approach to communicating with
and positively influencing youth, with intended diffusion to
school, family and community members. The CBPR frame-
work and novel approaches to implementation, we hope, will
contribute to long-term positive outcomes for the youth in the
study and long-term sustainability to continue these efforts
when NIH funding ends.
Developing strong partnerships between prevention scien-
tists and community prevention leaders, as well as technical
skill, knowledge and leadership development across multiple
community-based organizations provides a foundation for
sustainability of effective prevention strategies, as well as
continued research initiatives. We have created a positive
example of an effective CBPR approach that is combined with
a rigorously implemented experimental trial.
Besides a generalizable community-university partnership,
our community prevention leaders work for and are members
of a Native American tribe. Historical cultural losses, discrim-
ination, economic deprivation, and the accumulation of stress-
ful life events have led to multiple and significant health
disparities among Native Americans and underscore the need
for culturally sensitive and responsive approaches to address
these disparities. It is our hope that our tribal-university re-
search partnership provides a template for other such partner-
ships to tackle difficult health disparity issues with relevant
and responsive community action research. We agree withand
actively support the call for additional tribal-university part-
nerships that “focus on making a difference in the lives of
Indigenous people”(Whitbeck et al. 2014, p. 214), and for
creating and embracing equal partnerships.
Acknowledgments Research supported in this publication was sup-
ported by the NIAAA, with co-funding from the NIDA, of the National
Institutes of Health under Award Number 5R01AA02069. We also ac-
knowledge generous support from the Cherokee Nation and the Univer-
sity of Florida Institute for Child Health Policy. The content is solely the
responsibility of the authors and does not necessarily represent the
official views of the NIH, the University of Florida, or the
Cherokee Nation.
Open AccessThis article is distributed under the terms of the Creative
Commons Attribution License which permits any use, distribution, and
reproduction in any medium, provided the original author(s) and the
source are credited.
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