A Mother's Role in Delaying Onset of Sexual Activity in Her Children
|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.|
|ClinicalTrials.gov Identifier: NCT00060697|
Recruitment Status : Unknown
Verified May 2003 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was: Recruiting
First Posted : May 12, 2003
Last Update Posted : June 24, 2005
|Condition or disease||Intervention/treatment||Phase|
|Child Behavior Adolescent Behavior||Behavioral: Adolescent sexual activity education for mothers||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||1300 participants|
|Intervention Model:||Factorial Assignment|
|Official Title:||Family Intervention to Promote Health in Children|
|Study Start Date :||December 2000|
|Study Completion Date :||May 2005|
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
|Contact: Colleen K DiIorio, PhDfirstname.lastname@example.org|
|United States, Georgia|
|Atlanta, Georgia, United States, 30322|
|Contact: Colleen K DiIorio, PhD 404-727-8741 email@example.com|
|Principal Investigator:||Colleen K DiIorio, PhD||Emory University|