Delaying Sexual Activity in African American Adolescent Girls

June 23, 2005 updated by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

A Randomized Controlled Trial of the NIA Intervention

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

240

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15261
        • Recruiting
        • Dr. Willa Doswell
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 14 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

  • Principal Investigator: Willa Doswell, PhD, University of Pittsburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2001

Study Completion

January 1, 2006

Study Registration Dates

First Submitted

April 11, 2003

First Submitted That Met QC Criteria

April 14, 2003

First Posted (Estimate)

April 15, 2003

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

March 1, 2003

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1R01HD39757-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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