Evaluation of Becoming a Responsible Teen (BART)

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Teen Pregnancy Prevention

Clinical Trial Details

NCT number	NCT02539589
Study type	Interventional
Source	The Policy & Research Group
Contact
Status	Completed
Phase	N/A
Start date	June 2012
Completion date	August 2016

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.