Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00059241
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2003-04-22
Brief Title:
The Reach For Health Program Delaying Sexual Activity in Children
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Study Overview
Official Title:
Reach For Health--Middle Childhood Risk Prevention Study
Status:
UNKNOWN
Status Verified Date:
2003-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None