Adolescent Alcohol Use Clinical Trial
Official title:
A Dual Inoculation Approach to Alcohol Prevention Among African American Youth
The most common approach to preventing alcohol use involves providing a well-designed program in preadolescence just prior to or upon entering middle school. This approach does not have long-lasting effects or address the risk factors that lead many youth to use alcohol in high school. This study tested a strategy that compares offering effective programs at the transition to middle school and the transition to high school with only offering a program at either one of the transitions or no programs at all.
Alcohol use is a leading cause of morbidity and mortality among high school students.
Annually, underage drinking leads to more than 3,000 deaths and 2.6 million other harmful
events, resulting in $5.4 billion in medical costs, $14.9 billion in work loss and other
resource costs, and $41.6 billion in lost quality of life. This public health crisis has
engendered considerable attention from prevention scientists, who have specified guidelines
for the development of primary prevention programs and the timing of their implementation.
The present research is based on critical limitations in the prevailing model for
implementing primary prevention for alcohol use. This model focuses on delaying alcohol use
onset among youth who begin use in middle school (ages 11-14). Based on studies that linked
early use to a high-risk behavioral trajectory in adolescence, prevention scientists
translated data on risk and protective processes for early-onset alcohol use into primary
prevention programs for youth to be implemented during or just prior to the transition to
adolescence. This model has informed numerous randomized prevention trials and investigations
of prevention implementation. An unquestioned premise of this model involves the adequacy of
a single preadolescent "inoculation" of prevention programming to protect youth into the high
school years.
The proposed trial addresses empirical and theoretical limitations to the
preadolescent/single inoculation paradigm. First, inclusive reviews reveal that primary
prevention programs implemented in early adolescence fail to achieve robust, long-term
results. Second, studies of alcohol use trajectories reveal patterns of onset in high school
with rapid escalation that culminate in high levels of alcohol use. Third, in the prevailing
paradigm, targeting early adolescent risk processes is assumed to be sufficient to equip
youth for the novel risk processes they will encounter in high school. In contrast, this
study investigates the proposition that achievement of public health impact requires a
"dual-inoculation" prevention strategy, one that addresses both onset in early adolescence
and mid-adolescence and provides developmentally tailored curricula at each transition.
Based on longitudinal studies with rural African American families that documented the
changing context of alcohol use risk and protective processes from late childhood through
adolescence, scientists at the Center for Family Research developed a series of
developmentally appropriate, family-centered preventive interventions that have proven
efficacious in in preventing alcohol use: the Strong African American Families (SAAF) program
for youth age 10-12 and the SAAF-Teen program for youth age 14-16. These programs afford a
unique opportunity to test dual-inoculation hypotheses. Unlike medical inoculations of a
vaccine, it is not appropriate to give the same inoculation to an 11-year-old that one gives
a 14-year-old. Rather, each preventive inoculation must be tailored to address the most
salient risk and protective processes at particular developmental transitions.
This study will recruit a sample of 460 African American families into a four-arm randomized
prevention trial and evaluate the differential alcohol prevention effects of (a) a dual
inoculation of prevention (youth receive SAAF at age 11 and SAAF-Teen at age 14) compared
with (b) receipt of a preadolescent inoculation (SAAF at age 11), (c) receipt of a
mid-adolescent inoculation (SAAF-Teen at age 14), or (d) a minimal contact control.
Specific efficacy aims are to:
1. Test the hypothesis that rural African American youth randomly assigned to participate
in two prevention inoculations will demonstrate lower rates of alcohol use initiation,
frequency of use, binge drinking, and alcohol-related problems in high school than will
youth who receive a preadolescent inoculation only, a mid-adolescent inoculation only,
or no inoculations.
2. Investigate the intervening processes that account for the relative efficacy of a dual
inoculation. Specifically, we expect that intervention-targeted early adolescent
protective processes, early adolescent alcohol use outcomes, and intervention-targeted
mid-adolescent protective processes will account for group differences in alcohol use in
high school.
To facilitate the potential dissemination of a dual inoculation approach, this study
investigates the cost-effectiveness of a dual inoculation relative to preadolescent,
mid-adolescent, or control conditions.
The specific cost-effectiveness aim is to:
3. Conduct a cost-effectiveness analyses that estimates the incremental cost of a dual
inoculation compared to single inoculations and no inoculations per additional unit
decrease in alcohol use initiation, escalation, binge drinking, and alcohol-related
problems. This study will investigate an ancillary hypothesis involving the incremental
cost difference per outcome unit between preadolescent and mid-adolescent inoculations
relative to the control condition.
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