Healthy Futures Evaluation

Not Applicable

Completed

• Conditions: Sexual Behavior
• Interventions: Behavioral: Control; Behavioral: Healthy Futures

• Registration Number: NCT02554825
• Lead Sponsor: JSI Research & Training Institute, Inc.

Brief Summary

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

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 Timeline

• Study Start: 2011-08
• Primary Completion: 2015-03
• Study Completion: 2015-05
• Status Verified: 2015-09
• Study First Submitted: 2015-09-17
• Study First Submitted QC: 2015-09-17
• Last Update Submitted: 2015-09-17
• Study First Posted: 2015-09-18
• Last Update Posted: 2015-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1344

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• Students were not withdrawn from Healthy Futures program participation by himself/herself, a parent, or school administrator(s) prior to the consent/assent process for the study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• Students were withdrawn from Healthy Futures program participation by himself/herself, a parent, or school administrator(s) prior to the consent/assent process for the study.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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	-
Healthy Futures	Healthy Futures	-

Primary Outcome Measures

Name	Time	Method
Prevalence of participants who reported vaginal sex	2 Years	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?"

Trial Locations

Locations (1)

JSI Research & Training Institute, Inc.; 🇺🇸 Boston, Massachusetts, United States