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Home > "D" Clinical Trials Conditions > Delaying Sexual Activity in African American Adolescent Girls  Delaying Sexual Activity in African American Adolescent Girls
Delaying Sexual Activity in African American Adolescent Girls
For Condition: Sex Behavior,Adolescent behavior
Status: Recruiting
Sponsor(s): National Institute of Child Health and Human Development (NICHD) ,
Synopsis: This study will evaluate the effectiveness of a program designed to prevent early sexual behavior in middle school-aged African American girls.
Details: 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 intervention’s 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 study's 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.
Eligibility:
Study Type: Interventional, Prevention, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 11 Years/14 Years
Genders: Female
Protocol Entry Criteria: Inclusion Criteria - African American - 11 to 14.3 years old Exclusion Criteria - Participation in similar programs, such as Best Friends or Postponing Sexual Involvement - Classification in school as a special education student - Anorexia, bulimia, or chronic or acute reproductive health disease - Prior or current pregnancy - Prior participation in the community NIA girls' program
Total Enrollment: 240
Location and Contact Information:
Overall Study Official:
WillaDoswell, Principal Investigator, University of Pittsburgh
Dr. Willa Doswell *Recruiting*
Pittsburgh, Pennsylvania, 15261
United States
Recruiting Willa Doswell 412-624-8977
Additional Information:
Study ID Numbers: 1R01HD39757-1;
Study Start Date: February 2001
Record last reviewed: March 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00058760
Other Sex Behavior Studies:
1. Peer Mentors for Adolescents in HIV Affected Families
2. A Mother's Role in Delaying Onset of Sexual Activity in Her Children
3. Delaying Sexual Activity in African American Adolescent Girls
Related Studies:
Other Sex Behavior Clinical Trials
Other Pennsylvania Clinical Trials
Other Pittsburgh Clinical Trials
Delaying Sexual Activity in African American Adolescent Girls
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