NCT02539589

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
850

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2012

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

August 28, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 3, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

November 8, 2016

Status Verified

November 1, 2016

Enrollment Period

3.5 years

First QC Date

August 28, 2015

Last Update Submit

November 7, 2016

Conditions

Teen Pregnancy Prevention

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • One questionnaire item measuring frequency of sexual activity

    6 months after end of intervention

Study Arms (2)

Becoming a Responsible Teen (BART)

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.

Behavioral: BART

Healthy Living

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.

Behavioral: Healthy Living

Interventions

BARTBEHAVIORAL

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.

Becoming a Responsible Teen (BART)
Healthy LivingBEHAVIORAL

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.

Healthy Living

Eligibility Criteria

Age14 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Not have previously participated in any of the following pregnancy/HIV prevention programs:
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 26248171BACKGROUND

  • 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.

    PMID: 24560075BACKGROUND

Study Officials

  • Eric Jenner, PhD

    The Policy & Research Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2015

First Posted

September 3, 2015

Study Start

June 1, 2012

Primary Completion

December 1, 2015

Study Completion

August 1, 2016

Last Updated

November 8, 2016

Record last verified: 2016-11