The "Reach For Health" Program: Delaying Sexual Activity in Children

Child Behavior Clinical Trial

Official title:

Reach For Health--Middle Childhood Risk Prevention Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00059241
• Other study ID #: 5R01HD39537-2
• Status: Recruiting
• Phase: Phase 2
• First received: April 22, 2003
• Last updated: June 23, 2005
• Start date: July 2000

Study information

• Verified date: April 2003
• Source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 10 Years to 14 Years

Eligibility

Inclusion Criteria

• Youth attending NYC schools implementing "Reach for Health" program components and their parents

• Enrolled in general education classes

• Ability to complete survey assessments in English

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Child Behavior
• Sex Behavior

Intervention

Behavioral:
• Parent-child communication education

• Service learning

• Classroom health curriculum

Locations

Country	Name	City	State
United States	Education Development Center, Inc.	Newton	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States,