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Completed

NCT Number: NCT02554825

Healthy Futures Evaluation

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

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Key information

Conditions

Sexual Behavior Behavior

Age range

10 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

JSI Research & Training Institute, Inc.

Boston, Massachusetts, 02210, United States

About this study

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).

Who can participate

Only the study team can determine whether someone qualifies for participation.

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  • Students were not withdrawn from Healthy Futures program participation by himself/herself, a parent, or school administrator(s) prior to the consent/assent process for the study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  • Students were withdrawn from Healthy Futures program participation by himself/herself, a parent, or school administrator(s) prior to the consent/assent process for the study.

Treatment and study plan

Healthy Futures

Behavioral

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.

Control

Behavioral

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.

Primary outcomes

  1. Prevalence of participants who reported vaginal sex

    Time frame: 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?"

Sponsors and collaborators

Lead sponsor

JSI Research & Training Institute, Inc.

Other

Collaborators

  • Black Ministerial Alliance of Greater Boston
  • Department of Health and Human Services
  • Healthy Futures

Registry information

Official study title

Healthy Futures Longitudinal School-Cluster Randomized Controlled Trial

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Sep 18, 2015
Registry last updated
Sep 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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