Building Futures for Youth - Phase III

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: 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 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; (submitted: June 19, 2006)	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	INCLUSION CRITERIA: 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	Sexes Eligible for Study: All
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