- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02539589
Evaluation of Becoming a Responsible Teen (BART)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Becoming a Responsible Teen (BART)
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 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
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 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Two questionnaire items measuring consistency of condom use
Time Frame: 6 months after the end of intervention
|
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:
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
One questionnaire item measuring frequency of sexual activity
Time Frame: 6 months after end of intervention
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Eric Jenner, PhD, The Policy & Research Group
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 5 TP1AH000003-02-00 BART
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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