Evaluation of Becoming a Responsible Teen (BART)

Teen Pregnancy Prevention Clinical Trial

Official title:

Evaluation of Becoming a Responsible Teen (BART)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02539589
• Other study ID #: 5 TP1AH000003-02-00 BART
• Status: Completed
• Phase: N/A
• First received: August 28, 2015
• Last updated: November 7, 2016
• Start date: June 2012
• Est. completion date: August 2016

Study information

• Verified date: November 2016
• Source: The Policy & Research Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 850
• Est. completion date: August 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 18 Years

Eligibility

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

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

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
The Policy & Research Group	Department of Health and Human Services

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Two questionnaire items measuring consistency of condom use	The outcome is measured as the proportion of times in the past three months a person reports having any type of sex without using a condom. The outcome variable is calculated from the following items on the Questionnaire administered 6 months after the programs end: In total, how many times have you had any type of sex in the past 3 months?; Now, think about the number of times that you had any type of sex in the past 3 months. How many of those times did you use condoms?; The resulting variable is a continuous proportion with values that range from 0 to 1, where 0 indicates that a person has not engaged in sex without a condom in the past three months, and 1 indicates that the person has engaged in sex without a condom 100% of the times they had sex in the past three months.	6 months after the end of intervention	No
Secondary	One questionnaire item measuring frequency of sexual activity	The outcome is measured as the number of times in the past three months a person reports having any type of sex; The measure is taken directly from the following item on the Questionnaire: • In total, how many times have you had any type of sex in the past 3 months?; The variable is continuous, with values ranging from 0 to k, where 0= no sexual activity reported in past 3 months and k = number of times sex reported.	6 months after end of intervention	No