Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00060697
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2003-05-09
Brief Title:
A Mothers Role in Delaying Onset of Sexual Activity in Her 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:
Family Intervention to Promote Health in Children
Status:
UNKNOWN
Status Verified Date:
2003-05
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:
The goal of this study is to enhance the mothers role in promoting avoidance of sexual risks and problem behaviors in 6- to 12-year-old children Consenting mothers will attend a 10-session program designed to enhance the quality of mother-child communication identify sexual risks and increase parental monitoring and self-efficacy
Detailed Description:
This study will identify personal parental peer and community factors that predispose children ages 6 to 12 to early initiation of sexual behavior or that foster resilience to sexual risk taking The study will then evaluate an intervention designed to enhance resilience factors and reduce risk factors among 6- to 12-year-old children The study will focus on the mothers role in promoting resilience to sexual risk taking
During the first phase of the study 300 children and their mothers will be asked to complete a one-time interview that includes an assessment of risk and resilience factors Information from the interviews will be used to modify an intervention currently being used in another study of parent-adolescent pairs The modified intervention will then be tested to determine the efficacy of the intervention in reducing risk and enhancing resilience among children in this age group
In the second phase of the study 296 children and their mothers will be randomized to either the intervention or control group All mothers will complete a baseline interview Mothers in the intervention group will attend 10 group sessions that include short presentations discussions media presentations videotapes and interactive exercises including self-assessments role plays and games The group sessions include content and skill development related to parenting communication sexuality peer pressure and school involvement Mothers in the control group receive written information on diet and physical activity The written materials are presented in a self-help format to increase physical activity a cookbook contains low fat recipes designed especially for African American men and women living in the Atlanta GA area
All participants complete follow-up interviews at 6 and 12 months after the baseline interview Primary outcomes for mothers include measures of resilience and communication related to sexual issues For children outcomes include measures related to possible sexual situations
During the first phase of the study 300 children and their mothers will be asked to complete a one-time interview that includes an assessment of risk and resilience factors Information from the interviews will be used to modify an intervention currently being used in another study of parent-adolescent pairs The modified intervention will then be tested to determine the efficacy of the intervention in reducing risk and enhancing resilience among children in this age group
In the second phase of the study 296 children and their mothers will be randomized to either the intervention or control group All mothers will complete a baseline interview Mothers in the intervention group will attend 10 group sessions that include short presentations discussions media presentations videotapes and interactive exercises including self-assessments role plays and games The group sessions include content and skill development related to parenting communication sexuality peer pressure and school involvement Mothers in the control group receive written information on diet and physical activity The written materials are presented in a self-help format to increase physical activity a cookbook contains low fat recipes designed especially for African American men and women living in the Atlanta GA area
All participants complete follow-up interviews at 6 and 12 months after the baseline interview Primary outcomes for mothers include measures of resilience and communication related to sexual issues For children outcomes include measures related to possible sexual situations
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