Healthy Futures Evaluation

Sexual Behavior Clinical Trial

Official title:

Healthy Futures Longitudinal School-Cluster Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02554825
• Other study ID #: JSI R&T #13-012
• Status: Completed
• Phase: N/A
• First received: September 17, 2015
• Last updated: September 17, 2015
• Start date: August 2011
• Est. completion date: May 2015

Study information

• Verified date: September 2015
• Source: JSI Research & Training Institute, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1344
• Est. completion date: May 2015
• Est. primary completion date: March 2015
• Gender: Both
• Age group: 10 Years to 15 Years

Eligibility

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• Students were not withdrawn from Healthy Futures program participation by himself/herself, a parent, or school administrator(s) prior to the consent/assent process for the study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• Students were withdrawn from Healthy Futures program participation by himself/herself, a parent, or school administrator(s) prior to the consent/assent process for the study.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

Allocation: Randomized, Intervention Model: Parallel Assignment, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Sexual Behavior

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	JSI Research & Training Institute, Inc.	Boston	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
JSI Research & Training Institute, Inc.	Black Ministerial Alliance of Greater Boston, Department of Health and Human Services, Healthy Futures

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No