Overview

This trial has been completed.

Condition teen pregnancy prevention
Treatments bart, healthy living
Sponsor The Policy & Research Group
Collaborator Department of Health and Human Services
Start date June 2012
End date December 2015
Trial size 850 participants
Trial identifier NCT02539589, 5 TP1AH000003-02-00 BART

Summary

The purpose of the study is to determine the impact of the offer to participate in Becoming a Responsible Teen (BART) (treatment) relative to the offer to participate in Healthy Living (control) on two self-reported sexual behaviors (condom use and frequency of sex) six months after the end of treatment.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Becoming a Responsible Teen (BART) is the treatment condition. BART is an out of school educational program that intends to provide cognitive behavioral training to reduce HIV risk.
bart
BART is an out of school educational program that intends to provide cognitive behavioral training to reduce HIV risk. It is intended to be implemented in 8 sessions lasting 1.5-2 hours. Sessions are to be implemented by a male and female health educator in small gender specific groups of 5-15 participants.
(Active Comparator)
Healthy Living is the control counterfactual condition. It is a knowledge-based intervention that aims to impact nutrition, healthy eating, body image, and exercise.
healthy living
Healthy Living is a knowledge-based intervention that intends to provide one HIV information-only session and seven sessions on nutrition, healthy eating, body image, and exercise. It is intended to be implemented in 8 sessions lasting 1.5-2 hours. Sessions are to be implemented by a male and female health educator in small gender specific groups of 5-15 participants.

Primary Outcomes

Measure
Two questionnaire items measuring consistency of condom use
time frame: 6 months after the end of intervention

Secondary Outcomes

Measure
One questionnaire item measuring frequency of sexual activity
time frame: 6 months after end of intervention

Eligibility Criteria

Male or female participants from 14 years up to 18 years old.

Inclusion Criteria: - Between the ages of 14-18 - City youth worker assigned to a job site that is offering program - Provide parental consent (if under age 18) and participant assent to participate in the study. Exclusion Criteria: - Not have previously participated in any of the following pregnancy/HIV prevention programs: - 4 Real Health - Becoming a Responsible Teen (BART) - Healthy Living - Staying Mature and Responsible Towards Sex (SMARTS) - Sisters Informing Healthy Living and Empowering (SIHLE) - Project AIM - Making Proud Choices - Be Proud Be Responsible, or - Focus on Your Future

Additional Information

Official title Evaluation of Becoming a Responsible Teen (BART)
Principal investigator Eric Jenner, PhD
Description The Policy & Research Group (PRG) will be evaluating the Becoming a Responsible Teen (BART) curriculum. As part of the program, participants will be randomly assigned to receive either BART (treatment) or the Healthy Living (control) curriculum. BART is an eight-session group-level HIV/AIDS risk reduction curriculum based on Social Learning Theory and Self-efficacy Theory. The Healthy Living curriculum consists of the first session of BART (HIV information-only) followed by seven sessions of nutrition and physical activity education. The study is an individual randomized controlled trial in which eligible, consenting participants were randomly assigned by evaluators to intervention or control conditions. Random assignment occurred after evaluation consent/assent had been obtained and before the provision of any programming or collection of baseline data. There was no difference in the consent process for the intervention or control groups. Most study participants were randomized at approximately the same time—the first day of programming. Others were randomized when they showed up to a study site for the first time sometime during the first or second week of programming. Participant assignment was blocked by employment site, work shift, and gender. Baseline, outcome, and covariate data were collected via self-administered questionnaires that were scheduled at the following times: baseline (before the first program session attended); immediate post-program follow-up; 6-month post-program follow-up; and 12-month post-program follow-up. The study took place in New Orleans, Louisiana, as part of an educational component of a summer employment program funded by the city government. The government program contracts with multiple local community-based organizations (CBOs) to offer summer camps, internships, job training, and employment opportunities for youth ages 14 to 21 who reside in Orleans Parish. Each summer, these CBOs implemented the BART and Healthy Living programs as a component of their summer programming. Youth were recruited and enrolled during three consecutive summers (2012 to 2014), with programming ending each summer by late July. Six-month follow-up data collections occurred February to July of each year. Twelve-month follow-up data collections were generally offered from July to January of each year.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by The Policy & Research Group.