Child Behavior Clinical Trial
Official title:
Reach For Health--Middle Childhood Risk Prevention Study
Working with multiple schools in Brooklyn, NY, this study will develop and evaluate school- and community-based strategies designed to reduce early sexual activity and risky sexual behavior in middle school-aged children. These strategies will focus on parent education, classroom health curriculum, and learning through participation in community service.
Given the early age of sexual initiation among urban minority youth, interventions aimed at
reducing sexual initiation and risky sexual behavior related to HIV and other sexually
transmitted infections (STIs) should begin prior to entry into middle school. These
interventions should support both students and their parents through the transition to early
adolescence. In collaboration with the New York City Public Schools, this study is designed
to evaluate strategies to prevent early sexual initiation and its precursors among
academically at-risk urban minority boys and girls.
This study will answer two questions: 1) do factors that predict sexual risk taking and its
precursors in young adolescence operate similarly in middle childhood; and 2) can
interventions shown to be effective in early adolescence be developmentally adapted for
middle childhood to delay sexual initiation and its precursors? The study will evaluate the
impact of the intervention on mechanisms hypothesized to reduce sexual risk taking and its
precursors, including the personal resiliency and social competencies of youth. The study
will also collect data on the costs and process of implementation to inform subsequent
dissemination.
Participants in this study will be fifth and sixth grade children enrolled in participating
public schools in Brooklyn, NY. Participating school communities will be predominantly
African American and Latino. In the fall of their fifth and sixth grade years, students and
their families are assigned at random to participate in either a parent education group or
in a control group. The parent education program, “Saving Sex for Later,” focuses on the
transition from middle childhood to early adolescence, the pressures to engage in risk
behaviors (including early sexual initiation and related risks), and peer and parental
influences on youth attitudes and behaviors. Those in the control condition receive a
classroom health curriculum. In addition, a subgroup in each grade level is assigned to
participate in service learning, an educational method in which personal and community
values are taught through experience in structured service activities.
Youth will be followed for 12 to 18 months. Surveys will be conducted in the fall of the
fifth and sixth grade years and again at a 3-month post intervention follow-up. These
surveys will measure youth attitudes and behaviors, including precursors to early sexual
initiation and related risk behaviors. Surveys of parents' attitudes and behaviors will also
be conducted to supplement information from youth. To assist in interpreting results of the
surveys, in-depth qualitative interviews will be conducted with a subgroup of fifth grade
youth; these youth will be resurveyed prior to entry into seventh grade.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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