Cardiovascular Diseases Clinical Trial
To conduct a randomized controlled smoking prevention trial to evaluate quality of implementation and effectiveness, as a function of provider type (school teacher vs. nurse) and training (mediated vs. interactive).
DESIGN NARRATIVE:
The study compared smoking prevention in junior high schools and in high schools either
receiving or not receiving a school-wide community intervention. The junior high school
curriculum was delivered to all volunteers in grades 6, 7, and 8 in each intervention
school. All participants were tested five times: midway through grade 6 before the
intervention began, and at the end of grades 7,8,9, and 10. The primary endpoint was
self-reported smoking status at the ends of grades 8 and 10. The validity of smoking reports
was enhanced with collection of breath carbon monoxide samples for all subjects at all test
points.
The study was extended for an additional three years to add to the three year, junior high,
design a two arm comparison between high schools either receiving or not receiving a
school-wide, community, intervention. The new high school intervention responded to both
recent evidence of long term decay in junior high program effectiveness, and a trend toward
greater high school smoking onset most notably among females. Secondary objectives for this
Demonstration and Education research included (a) a test of the hypothesis that higher
levels of implementation were associated with better outcomes; (b) preparation for diffusion
of a complete set of curriculum, provider training, program implementation, and evaluation
methods and materials; and (c) study of the effects of school environment on program
effectiveness.
One hundred junior high schools were randomly selected and assigned, 20 per condition, and
some 5,000 Grade 6 youth with approximately the same number of females and males, recruited
to cohort which participated in intervention and evaluation through the end of Grade 10. The
junior high curriculum was delivered to all volunteers in each intervention school in Grades
6, 7, and 8. All participants were tested five times: midway through Grade 6 before the
intervention began, and at the end of Grades 7, 8, 9 and 10. The primary endpoint was
self-reported smoking status at the ends of Grades 8 and 10, 2 1/2 and 4 1/2 years after the
intervention began. The validity of smoking reports were enhanced with collection of breath
carbon monoxide samples from all subjects at all test points.
The new high school intervention integrated three approaches: attitude-behavior change
strategies derived from social psychological research on dissonance, self-perception,
values, social norms, and commitment; organizational/cultural change strategies using
student- driven participatory planning and multilevel change methods; and mobilization
strategies adapted from the National Cancer Institute-funded Community Intervention Trial
for Smoking Cessation (COMMIT). A comprehensive implementation evaluation used direct
observation, multiple sources of self-report, program records, and cost data to assess the
relationships between implementation, outcome, and cost- effectiveness; to provide direct
measures of training and mobilization effects; and to develop feasible implementation
evaluation methodology for future diffusion studies.
The study completion date listed in this record was obtained from the "End Date" entered in
the Protocol Registration and Results System (PRS) record.
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N/A
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