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.
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)
- Type of treatment
- Lifestyle or therapy programme
- 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
- Recruiting
Dr. Willa Doswell
Pittsburgh, Pennsylvania, 15261
Willa M Doswell, PhD, 412-624-8977, wdo100@pitt.edu
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.
- Conditions
- Adolescent Behavior, Sex Behavior
- 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.
- First posted15 Apr 2003 (estimated)
- Study startFeb 2001
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Investigators
- Willa Doswell, PhD, Principal investigator, University of Pittsburgh
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of the NIA Intervention
- ClinicalTrials.gov ID
- NCT00058760
- Acronym / sponsor ID
- 1R01HD39757-1
- Conditions
- Adolescent Behavior, Sex Behavior
- Keywords
- Prevention of early sexual behavior, NIA intervention
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- Feb 2001
- Study completion
- Jan 2006
- First posted
- 15 Apr 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the effectiveness of a program designed to prevent early sexual behavior in middle school-aged African American girls.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 11 to 14 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- African American
- 11 to 14.3 years old
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NIA intervention (after school health promotion didactic program) | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Willa Doswell, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
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.