Clinical trial NCT02539589: Evaluation of Becoming a Responsible Teen (BART)
Official title: Evaluation of Becoming a Responsible Teen (BART)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Teen Pregnancy Prevention
Lead sponsor: The Policy & Research Group
Sponsor class: OTHER
Collaborators: name: Department of Health and Human Services
First posted: 2015-09-03
Enrollment: 850
Sex: ALL
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Two questionnaire items measuring consistency of condom use
timeFrame: 6 months after the end of intervention
Secondary outcomes:
measure: One questionnaire item measuring frequency of sexual activity
timeFrame: 6 months after end of intervention
Other outcomes:
Locations:
Study officials:
affiliation: The Policy & Research Group
name: Eric Jenner, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Walsh S, Jenner E, Leger R, Broussard M. Effects of a Sexual Risk Reduction Program for African-American Adolescents on Social Cognitive Antecedents of Behavior Change. Am J Health Behav. 2015 Sep;39(5):610-22. doi: 10.5993/AJHB.39.5.3.
citation: Demby H, Gregory A, Broussard M, Dickherber J, Atkins S, Jenner LW. Implementation lessons: the importance of assessing organizational "fit" and external factors when implementing evidence-based teen pregnancy prevention programs. J Adolesc Health. 2014 Mar;54(3 Suppl):S37-44. doi: 10.1016/j.jadohealth.2013.12.022.