Building Futures for Youth - Phase III
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00341471 |
Recruitment Status
:
Completed
First Posted
: June 21, 2006
Last Update Posted
: July 2, 2017
|
Tracking Information | |||
---|---|---|---|
First Submitted Date ICMJE | June 19, 2006 | ||
First Posted Date ICMJE | June 21, 2006 | ||
Last Update Posted Date | July 2, 2017 | ||
Study Start Date ICMJE | January 18, 2006 | ||
Actual Primary Completion Date | October 8, 2008 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE | Not Provided | ||
Original Primary Outcome Measures ICMJE | Not Provided | ||
Change History | Complete list of historical versions of study NCT00341471 on ClinicalTrials.gov Archive Site | ||
Current Secondary Outcome Measures ICMJE | Not Provided | ||
Original Secondary Outcome Measures ICMJE | Not Provided | ||
Current Other Outcome Measures ICMJE | Not Provided | ||
Original Other Outcome Measures ICMJE | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | Building Futures for Youth - Phase III | ||
Official Title ICMJE | Adolescent Pregnancy Prevention: Building Futures for Youth | ||
Brief 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. 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:
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 Type ICMJE | Interventional | ||
Study Phase | Phase 3 | ||
Study Design ICMJE | Primary Purpose: Treatment | ||
Condition ICMJE | Adolescent Pregnancy | ||
Intervention ICMJE | Procedure: Risk Behavior Prevention Intervention Program | ||
Study Arms | Not Provided | ||
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. | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||
Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Estimated Enrollment ICMJE |
2500 | ||
Original Enrollment ICMJE | Same as current | ||
Actual Study Completion Date | October 8, 2008 | ||
Actual Primary Completion Date | October 8, 2008 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE |
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. |
||
Sex/Gender |
|
||
Ages | Child, Adult, Senior | ||
Accepts Healthy Volunteers | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | United States | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT00341471 | ||
Other Study ID Numbers ICMJE | 999906078 06-CH-N078 |
||
Has Data Monitoring Committee | Not Provided | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement | Not Provided | ||
Responsible Party | Not Provided | ||
Study Sponsor ICMJE | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | National Institutes of Health Clinical Center (CC) | ||
Verification Date | May 18, 2011 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |