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

NCT ID: NCT00059241

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

1200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Sex Behavior Child Behavior

Keywords

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Early sexual initiation Prevention of early sexual activity Middle childhood

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Parent-child communication education

Intervention Type BEHAVIORAL

Service learning

Intervention Type BEHAVIORAL

Classroom health curriculum

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

NIH

Sponsor Role lead

Principal Investigators

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Lydia O'Donnell, Ed.D.

Role: PRINCIPAL_INVESTIGATOR

Education Development Center, Inc.

Locations

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Education Development Center, Inc.

Newton, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Lydia O'Donnell, Ed.D.

Role: primary

Other Identifiers

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5R01HD039537

Identifier Type: NIH

Identifier Source: secondary_id

View Link

5R01HD39537-2

Identifier Type: -

Identifier Source: org_study_id