Delaying Sexual Activity in African American Adolescent Girls

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2003 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00058760
First received: April 11, 2003
Last updated: June 23, 2005
Last verified: March 2003
  Purpose

This study will evaluate the effectiveness of a program designed to prevent early sexual behavior in middle school-aged African American girls.


Condition Intervention Phase
Adolescent Behavior
Sex Behavior
Behavioral: NIA intervention (after school health promotion didactic program)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial of the NIA Intervention

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

Estimated Enrollment: 240
Study Start Date: February 2001
Estimated Study Completion Date: January 2006
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 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

Ages Eligible for Study:   11 Years to 14 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00058760

Locations
United States, Pennsylvania
Dr. Willa Doswell Recruiting
Pittsburgh, Pennsylvania, United States, 15261
Contact: Willa M Doswell, PhD    412-624-8977    wdo100@pitt.edu   
Sponsors and Collaborators
Investigators
Principal Investigator: Willa Doswell, PhD University of Pittsburgh
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00058760     History of Changes
Other Study ID Numbers: 1R01HD39757-1
Study First Received: April 11, 2003
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Prevention of early sexual behavior
NIA intervention

ClinicalTrials.gov processed this record on September 29, 2014