Delaying Sexual Activity in African American Adolescent Girls

NCT ID: NCT00058760

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-02-28

Study Completion Date

2006-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Adolescent Behavior Sex Behavior

Keywords

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Prevention of early sexual behavior NIA intervention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Interventions

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NIA intervention (after school health promotion didactic program)

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

11 Years

Maximum Eligible Age

14 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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

NIH

Sponsor Role lead

Principal Investigators

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Willa Doswell, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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Dr. Willa Doswell

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Willa M Doswell, PhD

Role: primary

Other Identifiers

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1R01HD039757

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1R01HD39757-1

Identifier Type: -

Identifier Source: org_study_id