NCT02554825

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,344

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 18, 2015

Completed
Last Updated

September 18, 2015

Status Verified

September 1, 2015

Enrollment Period

3.6 years

First QC Date

September 17, 2015

Last Update Submit

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

EXPERIMENTAL
Behavioral: Healthy Futures

Control

OTHER
Behavioral: Control

Interventions

Healthy FuturesBEHAVIORAL

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.

Healthy Futures
ControlBEHAVIORAL

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.

Control

Eligibility Criteria

Age10 Years - 15 Years
Sexall
Age GroupsChild (0-17)

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

Study Sites (1)

JSI Research & Training Institute, Inc.

Boston, Massachusetts, 02210, United States

Location

MeSH Terms

Conditions

Sexual Behavior

Condition Hierarchy (Ancestors)

Behavior

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

Locations