Healthy Futures Evaluation
Healthy Futures Longitudinal School-Cluster Randomized Controlled Trial
1 other identifier
interventional
1,344
1 country
1
Brief Summary
This study evaluated the impact of the three-year Healthy Futures program on teen sexual behaviors in three Massachusetts cities.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
September 17, 2015
CompletedFirst Posted
Study publicly available on registry
September 18, 2015
CompletedSeptember 18, 2015
September 1, 2015
3.6 years
September 17, 2015
September 17, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Prevalence of participants who reported vaginal sex
Participants were followed for the duration of the three-year Healthy Futures program delivered in 6th, 7th, and 8th grades. The primary outcome was measured approximately two years (8th grade) after the baseline (6th grade) questionnaire. Prevalence of participants who reported vaginal sex was measured by participant response \[Yes/No\] to the question: "For the purposes of this survey, by sex, we mean a male putting his penis into a female's vagina. Other ways of saying sex are "doing it" or going all the way". Have you ever had sex?"
2 Years
Study Arms (2)
Healthy Futures
EXPERIMENTALControl
OTHERInterventions
Healthy Futures is an age-appropriate program that targets change at different social ecological levels-individual, interpersonal, and organizational. The main component is a classroom-based relationship education curriculum, Nu-CULTURE, offered in 6th, 7th, and 8th grade for eight 50-minute sessions each year. A number of supplemental efforts aim to enhance the Nu-CULTURE program and create social supports: 1) virtual classrooms where participating youth are encouraged to visit age-appropriate youth websites; 2) daily interactive parental connection forms linked with Nu-CULTURE, a parent website, and workshops (True Connections); 3) a 10-week after-school program, Rhymin' it Write, encourages youth leadership; 4) a 6-week summer program, Code A, engages youth during out-of-school time after 8th grade.
The Control Curriculum offers students in the control group two 50-minute classes each year on general health education topics. Students in the 6th grade receive a class on puberty/reproduction and a class on bullying prevention; students in the 7th grade receive two classes on dating-violence prevention; and students in the 8th grade receive two classes on mental health promotion.
Eligibility Criteria
You may qualify if:
- Students attended one of the 15 participating public middle schools
- Students were enrolled in the 6th grade in the 2011-2012 school year (Cohort 1) or 2012-2013 school year (Cohort 2)
- Students were not withdrawn from Healthy Futures program participation by himself/herself, a parent, or school administrator(s) prior to the consent/assent process for the study
You may not qualify if:
- Students were were not in the 6th grade at the time of consent
- Students were not in the school after the consent/assent process occurred
- Students were withdrawn from Healthy Futures program participation by himself/herself, a parent, or school administrator(s) prior to the consent/assent process for the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- JSI Research & Training Institute, Inc.lead
- Department of Health and Human Servicescollaborator
- Black Ministerial Alliance of Greater Bostoncollaborator
- Healthy Futurescollaborator
Study Sites (1)
JSI Research & Training Institute, Inc.
Boston, Massachusetts, 02210, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 17, 2015
First Posted
September 18, 2015
Study Start
August 1, 2011
Primary Completion
March 1, 2015
Study Completion
May 1, 2015
Last Updated
September 18, 2015
Record last verified: 2015-09