Healthy Futures Evaluation

Healthy Futures Longitudinal School-Cluster Randomized Controlled Trial

This study evaluated the impact of the three-year Healthy Futures program on teen sexual behaviors in three Massachusetts cities.

Study Overview

• Status: Completed
• Conditions: Sexual Behavior
• Intervention / Treatment: Behavioral: Healthy Futures; Behavioral: Control

Detailed Description

This study evaluated the impact of the three-year Healthy Futures program on teen sexual behaviors in three Massachusetts cities. This longitudinal school-cluster randomized controlled trial included 15 public middle schools (n=1,344). Participants were enrolled in the 6th grade in the 2011-2012 school year (Cohort 1) or 2012-2013 school year (Cohort 2). Outcome data sources included five student surveys: baseline; 6th, 7th, 8th grade follow-ups; and 9th grade follow-up (Cohort 1 only).

• Study Type: Interventional
• Enrollment (Actual): 1344
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02210
      • JSI Research & Training Institute, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 15 years (Child)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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• Students were not withdrawn from Healthy Futures program participation by himself/herself, a parent, or school administrator(s) prior to the consent/assent process for the study

Exclusion Criteria:

• 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• Students were withdrawn from Healthy Futures program participation by himself/herself, a parent, or school administrator(s) prior to the consent/assent process for the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control	Behavioral: Control; 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.
Experimental: Healthy Futures	Behavioral: Healthy Futures; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: JSI Research & Training Institute, Inc.
• Collaborators: Department of Health and Human Services; Black Ministerial Alliance of Greater Boston; Healthy Futures

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: September 17, 2015
• First Submitted That Met QC Criteria: September 17, 2015
• First Posted (Estimate): September 18, 2015

Study Record Updates

• Last Update Posted (Estimate): September 18, 2015
• Last Update Submitted That Met QC Criteria: September 17, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: JSI R&T #13-012