Adolescent PregnancyPhase 3NCT00341471
Building Futures for Youth - Phase III
A Phase 3 study testing Risk Behavior Prevention Intervention Program in people with Adolescent Pregnancy, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
Trial summary
The Building Futures for Youth (BFY) project is a pilot intervention program for 6th grade students and their parents in the District of Columbia public school system. The full intervention will include students in the 6th, 7th and 8th grades. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Adolescent Pregnancy
- What is being tested?
- Risk Behavior Prevention Intervention Program
- Type of treatment
- Surgery or procedure
- How many people
- 2,500 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jan 2006to 8 Oct 2008
- Phase
- Phase 3
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The target population for the pilot year is primarily African-American children who are sixth grade students at the participating schools.
- Active parental consent will be required for all participants and will be required for all participants and will be required separately for participation in the classroom intervention session and participation in Club SERVE.
- All children who can understand English will be included in the study.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Howard University Hospital
Washington D.C., District of Columbia, 20060
About this study
Official title: Adolescent Pregnancy Prevention: Building Futures for Youth
The Building Futures for Youth (BFY) project is a pilot intervention program for 6th grade students and their parents in the District of Columbia public school system. The full intervention will include students in the 6th, 7th and 8th grades. The primary overall goal of the project is to help students learn to make healthy life choices and delay sexual initiation.
Sixth-grade children and parents in four Washington, D.C., public schools will be recruited for this study. Children from two schools will participate in the BFY intervention program and children from two other schools will serve as controls. Participants are guided through three study phases, with each phase spanning one school year, as follows:
Read more
Sixth-grade students are given a foundation in goal setting, decision-making and communication skills. They gain knowledge about puberty, reproduction, and the negative consequences associated with having a child at a young age. They learn strategies for getting out of situations in which they feel pressured to engage in sexual activity. Through lessons, activities, and discussions they are given tools to answer the following questions:
- Who am I? Students engage in self-reflection activities and discussions that allow them to become aware of their values, beliefs and strengths, increasing self-esteem and a positive self-image.
- What do I want for my life? Students engage in goal-setting activities, creating short-term and long-term goals and mapping out the necessary steps to achieve the goals.
- How do I get there? Students are instructed in decision-making, problem-solving and communication skills.
- How can having sex too early affect my life and the goals I want to achieve? Students explore the negative impact that engaging in sexual activity too early and getting pregnant or getting someone pregnant can have on their emotional, social and financial lives.
Seventh grade students are given the tools and skills necessary to deal with a variety of challenges they may experience during their developmental years. They receive comprehensive sex education, in conjunction with life skills such as relationship negotiation, dating skills, violence prevention and problem-solving skills.
Eighth grade students are guided through a series of activities that encourage students to translate knowledge gained in the 6th and 7th grade phases into long-term behavioral changes and risk reduction. Activities include writing and performing skills, creating an informational pamphlet, designing T-shirts and creating poetry that affirms the BFY message.
In addition, students participate in a program of community service projects, such as the Anacostia River clean-up coordinated by the Earth Conservation Corps and Martin Luther King Day events coordinated by Howard University's Community Association and Project Change.
Parents are provided skills training and information on a variety of issues relating to adolescent sexuality, parental monitoring and parent-child communication.
Read the detailed description
The Adolescent Pregnancy Prevention Project, or Building Futures for Youth, is embarking on a pilot year in order to test the effectiveness of a revised children's intervention for Grade 6. Although there was some evidence of a positive effect of the intervention for girls during Phase II, there were no significant effects for boys. In light of these findings, BFY will spend the current project year piloting a revised classroom intervention as well as a newly adapted after-school intervention component.
- Conditions
- Adolescent Pregnancy
- Being tested
- Risk Behavior Prevention Intervention Program
- Keywords
- School, Sixth Grade, Curricular, Howard University, D.C., Adolescent Pregnancy, Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk Behavior Prevention Intervention ProgramProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study start18 Jan 2006
- Primary completion8 Oct 2008
- Study completion8 Oct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adolescent PregnancyStudies 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 3
- Primary purpose
- Treatment
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00341471
- Sponsor's protocol ID
- 999906078
- Other IDs
- 06-CH-N078
- Status last verified
- 18 May 2011
- First submitted
- 19 Jun 2006
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Koo HP, Rose A, El-Khorazaty MN, Yao Q, Jenkins RR, Anderson KM, Davis M, Walker LR. Evaluation of a randomized intervention to delay sexual initiation among fifth-graders followed through the sixth grade. Sex Educ. 2011 Feb;11(1):27-46. doi: 10.1080/14681811.2011.538146.
PubMed 21857793
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adolescent Pregnancy Prevention: Building Futures for Youth
- ClinicalTrials.gov ID
- NCT00341471
- Acronym / sponsor ID
- 999906078
- Conditions
- Adolescent Pregnancy
- Keywords
- School, Sixth Grade, Curricular, Howard University, D.C., Adolescent Pregnancy, Intervention
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- 18 Jan 2006
- Primary completion
- 8 Oct 2008 (actual)
- Study completion
- 8 Oct 2008 (actual)
- First posted
- 21 Jun 2006 (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.
The Building Futures for Youth (BFY) project is a pilot intervention program for 6th grade students and their parents in the District of Columbia public school system. The full intervention will include students in the 6th, 7th and 8th grades. The primary overall goal of the project is to help students learn to make healthy life choices and delay sexual initiation.
Sixth-grade children and parents in four Washington, D.C., public schools will be recruited for this study. Children from two schools will participate in the BFY intervention program and children from two other schools will serve as controls. Participants are guided through three study phases, with each phase spanning one school year, as follows:
Sixth-grade students are given a foundation in goal setting, decision-making and communication skills. They gain knowledge about puberty, reproduction, and the negative consequences associated with having a child at a young age. They learn strategies for getting out of situations in which they feel pressured to engage in sexual activity. Through lessons, activities, and discussions they are given tools to answer the following questions:
- Who am I? Students engage in self-reflection activities and discussions that allow them to become aware of their values, beliefs and strengths, increasing self-esteem and a positive self-image.
- What do I want for my life? Students engage in goal-setting activities, creating short-term and long-term goals and mapping out the necessary steps to achieve the goals.
- How do I get there? Students are instructed in decision-making, problem-solving and communication skills.
- How can having sex too early affect my life and the goals I want to achieve? Students explore the negative impact that engaging in sexual activity too early and getting pregnant or getting someone pregnant can have on their emotional, social and financial lives.
Seventh grade students are given the tools and skills necessary to deal with a variety of challenges they may experience during their developmental years. They receive comprehensive sex education, in conjunction with life skills such as relationship negotiation, dating skills, violence prevention and problem-solving skills.
Eighth grade students are guided through a series of activities that encourage students to translate knowledge gained in the 6th and 7th grade phases into long-term behavioral changes and risk reduction. Activities include writing and performing skills, creating an informational pamphlet, designing T-shirts and creating poetry that affirms the BFY message.
In addition, students participate in a program of community service projects, such as the Anacostia River clean-up coordinated by the Earth Conservation Corps and Martin Luther King Day events coordinated by Howard University's Community Association and Project Change.
Parents are provided skills training and information on a variety of issues relating to adolescent sexuality, parental monitoring and parent-child communication.
Detailed description
The Adolescent Pregnancy Prevention Project, or Building Futures for Youth, is embarking on a pilot year in order to test the effectiveness of a revised children's intervention for Grade 6. Although there was some evidence of a positive effect of the intervention for girls during Phase II, there were no significant effects for boys. In light of these findings, BFY will spend the current project year piloting a revised classroom intervention as well as a newly adapted after-school intervention component.
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- The target population for the pilot year is primarily African-American children who are sixth grade students at the participating schools.
- Active parental consent will be required for all participants and will be required for all participants and will be required separately for participation in the classroom intervention session and participation in Club SERVE.
- All children who can understand English will be included in the study.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Risk Behavior Prevention Intervention Program | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Derived from this study: PubMed 21857793Koo HP, Rose A, El-Khorazaty MN, Yao Q, Jenkins RR, Anderson KM, Davis M, Walker LR. Evaluation of a randomized intervention to delay sexual initiation among fifth-graders followed through the sixth grade. Sex Educ. 2011 Feb;11(1):27-46. doi: 10.1080/14681811.2011.538146.
Related trials for Adolescent Pregnancy
Recruiting
Estimating the Impact of Sexuality Education and Mobile Health Services on Reproductive Health and Empowerment Among Adolescents in Sierra Leone for the Family Planning Impact Lab
Reproductive Health, Sexual Health
Active, not recruitingPhase 3
A Study to Find Out How EMPAgliflozin is Tolerated and if it Helps Children and Adolescents With Chronic KIDNEY Disease (EMPA-KIDNEY® Kids)
Chronic Kidney Disease
RecruitingPhase 3
Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders
Turner Syndrome, Short Stature Homeobox Gene Mutation
RecruitingPhase 3
A Study to Find Out if BI 764198 Helps Adults and Adolescents With a Kidney Condition Called Focal Segmental Glomerulosclerosis (FSGS)
Focal Segmental Glomerulosclerosis
Recruiting
AYAHIV Role-based Responsibilities for Oncology-focused Workforce (ARROW)
Cervical Cancer, Kaposi Sarcoma
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Risk Behavior Prevention Intervention Program in people with Adolescent Pregnancy, 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 3 inclusion and 0 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: finished, as of the sponsor's last update on 2 Jul 2017. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00341471, which also lists 1 linked publication.
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 2 Jul 2017.