Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00058760
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2003-04-11
Brief Title:
Delaying Sexual Activity in African American Adolescent Girls
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:
A Randomized Controlled Trial of the NIA Intervention
Status:
UNKNOWN
Status Verified Date:
2003-03
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:
This study will evaluate the effectiveness of a program designed to prevent early sexual behavior in middle school-aged African American girls
Detailed Description:
There are 34 million adolescents between the ages of 11 and 17 years old in the United States Approximately 12 of them are African American These youths experience earlier pubertal onset and face earlier challenges to participate in sexual activity and therefore have earlier potential for pregnancy and contraction of sexually transmitted diseases Experts in adolescent research have recommended developing and implementing new interventions to reduce early sexual activity these interventions should target middle school-aged youths The purpose of this study is to evaluate the efficacy of the NIA intervention on intention to engage in early sexual behavior and actual involvement in early sexual behavior in a convenience sample of sixth and seventh grade African American girls
NIA is a Swahili word that means having a sense of purpose It is one of the seven principles of Kwanzaa a holiday that celebrates African Americans cultural roots in Africa The intervention was named after a self-development program for African American girls to highlight the interventions cultural basis
The study will provide 12 weekly and 5 booster after school didactic sessions these sessions will teach health promotion and decision making skills to help girls successfully avoid situations where sexual activity is invited Mothers and daughters will collaborate on homework assignments on puberty heterosexual relationships and sexual issues The study will provide an evening mother-daughter workshop on sexual responsibility and a Baby-Think-It-Over weekend experience for girls using a computerized doll Finally the study will provide five Hey Baby role-play vignettes to teach girls how to avoid heterosexual relationships that may lead to sexual activity
The NIA intervention will be compared against a usual after-school activity control group of sixth and seventh grade African American girls in two public middle schools in the Pittsburgh Public School system Participants will be randomly assigned to either the NIA intervention group or the control group Each participant will be in the study for 1 year There will be a 12-week main intervention in the fall a 5-week booster in the spring and final testing 1 year after study entry Assessments will be primarily paper and pencil tests of the studys main outcome variables attitude toward early sexual behavior ESB subjective norms mother father peer toward ESB intention to engage in ESB and self-reported ESB Additionally there will be knowledge content quizzes after each main intervention or booster session and a written evaluation of the Baby-Think-It-Over weekend
NIA is a Swahili word that means having a sense of purpose It is one of the seven principles of Kwanzaa a holiday that celebrates African Americans cultural roots in Africa The intervention was named after a self-development program for African American girls to highlight the interventions cultural basis
The study will provide 12 weekly and 5 booster after school didactic sessions these sessions will teach health promotion and decision making skills to help girls successfully avoid situations where sexual activity is invited Mothers and daughters will collaborate on homework assignments on puberty heterosexual relationships and sexual issues The study will provide an evening mother-daughter workshop on sexual responsibility and a Baby-Think-It-Over weekend experience for girls using a computerized doll Finally the study will provide five Hey Baby role-play vignettes to teach girls how to avoid heterosexual relationships that may lead to sexual activity
The NIA intervention will be compared against a usual after-school activity control group of sixth and seventh grade African American girls in two public middle schools in the Pittsburgh Public School system Participants will be randomly assigned to either the NIA intervention group or the control group Each participant will be in the study for 1 year There will be a 12-week main intervention in the fall a 5-week booster in the spring and final testing 1 year after study entry Assessments will be primarily paper and pencil tests of the studys main outcome variables attitude toward early sexual behavior ESB subjective norms mother father peer toward ESB intention to engage in ESB and self-reported ESB Additionally there will be knowledge content quizzes after each main intervention or booster session and a written evaluation of the Baby-Think-It-Over weekend
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