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Adolescent BehaviorPhase 1NCT00058760

Delaying Sexual Activity in African American Adolescent Girls

A Phase 1 study testing NIA intervention (after school health promotion didactic program) in people with Adolescent Behavior and Sex Behavior, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 11 to 14 years, women onlyHealthy volunteers can take part
Conditions the study is for
Adolescent Behavior, Sex Behavior
What is being tested?
NIA intervention (after school health promotion didactic program)
How many people
240 participants
Where
1 siteUnited States
Study dates
Feb 2001to Jan 2006
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 11 to 14 years
  • Women only
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • African American
  • 11 to 14.3 years old

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site, 1 recruiting
  • Dr. Willa Doswell

    Pittsburgh, Pennsylvania, 15261

    Willa M Doswell, PhD, 412-624-8977, wdo100@pitt.edu

    Recruiting

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
NIA intervention (after school health promotion didactic program)
Keywords
Prevention of early sexual behavior, NIA intervention
Medical subject headings
Adolescent Behavior, Sexual Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NIA intervention (after school health promotion didactic program)Behavioural

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2003 (estimated)
  2. Study startFeb 2001
  3. Study completionJan 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Enrolment
240 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00058760
Sponsor's protocol ID
1R01HD39757-1
Other IDs
1R01HD039757
Status last verified
Mar 2003
First submitted
11 Apr 2003
Last updated
24 Jun 2005
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing NIA intervention (after school health promotion didactic program) in people with Adolescent Behavior and Sex Behavior, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.

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