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A Mother's Role in Delaying Onset of Sexual Activity in Her Children

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2003 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00060697
First Posted: May 12, 2003
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  Purpose
The goal of this study is to enhance the mother's 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.

Condition Intervention Phase
Child Behavior Adolescent Behavior Behavioral: Adolescent sexual activity education for mothers Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single
Primary Purpose: Prevention
Official Title: Family Intervention to Promote Health in Children

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Estimated Enrollment: 1300
Study Start Date: December 2000
Estimated Study Completion Date: May 2005
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 mother’s 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 85 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  • Member of a participating community-based organization
  • Child 6 to 12 years of age and biological mother/legal guardian
  • Ability to read and comprehend English
  • Willing to participate
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00060697


Contacts
Contact: Colleen K DiIorio, PhD 404-727-8741 cdiiori@sph.emory.edu

Locations
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Colleen K DiIorio, PhD    404-727-8741    cdiiori@sph.emory.edu   
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Colleen K DiIorio, PhD Emory University
  More Information

ClinicalTrials.gov Identifier: NCT00060697     History of Changes
Other Study ID Numbers: 5R01HD39541-2
First Submitted: May 9, 2003
First Posted: May 12, 2003
Last Update Posted: December 9, 2005
Last Verified: May 2003

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Sexual risk taking
Mother-child communication
Problem behaviors