- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04027010
An Evaluation of Virtual Student Health Center Among Incarcerated Juvenile Offenders
A Randomized Controlled Trial of Virtual Student Health Center Among Incarcerated Juvenile Offenders
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
WestEd and its partners, Efficacity and the Oregon Youth Authority (OYA), were funded by the Department of Health and Human Services (DHHS) to conduct a randomized controlled trial of an innovative teen pregnancy prevention program, Healthy U (formally known as Virtual Student Health Center), for youthful male offenders to test the impact of this innovative, non-curricular, technology-based intervention, that is self-directed, low-cost, user friendly, and offers great promise in reaching incarcerated youth. Healthy U was designed to give adolescents and teens the tools they need to reduce their risk of unintended pregnancy and sexually transmitted diseases (STDs), including HIV, using a low-cost, transportable platform that is user-friendly for youth (and staff to oversee). In this project, we take the innovative Healthy U intervention and modify its implementation for juveniles in custody of a correctional facility.
This study involved male teenagers (ages 14-19) at high risk for involvement in risky sexual behavior, including teen pregnancy. The findings from this study are intended to contribute to research on both teen pregnancy and crime prevention. Teen parents and their children are at greater risk for subsequent criminal offending, and the children of teen parents also have greater risk of child abuse and neglect victimization. The current knowledge base suggests that youth exposed to the juvenile justice system have sex more often with more partners at a younger age and without protection (Bryan, Rocheleau, Robbins, & Hutchinson, 2005). This randomized study was designed to contribute to our understanding of what works with this population and to strengthen our knowledge base around developing and implementing technology-based interventions in a juvenile correctional environment.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Los Alamitos, California, United States, 90720
- WestEd
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Massachusetts
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Woburn, Massachusetts, United States, 01801
- WestEd
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male
- Aged 14-19
- OYA commits
- Have the cognitive ability to complete the baseline and follow-up surveys
- Need to be within 30-90 days of release
Exclusion Criteria:
- Female
- Outside of age criteria
- Oregon Department of Corrections commits
- Does not have the cognitive ability to complete the baseline and follow-up surveys
- Not within 30-90 days of release
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: "Healthy U" tablet application
Healthy U is a self-administered intervention implemented through a tablet app with interactive learning experiences, including videos, digital games, quizzes, and role-plays.
Healthy U takes youth 3-4 hours to complete.
The goals of Healthy U are to: 1) Increase male youth's perception of vulnerability to unplanned fatherhood, STDs and HIV; 2) Increase male youth's self-efficacy for negotiating condom use with their partners; 3) Increase male youth's self-efficacy for using condoms correctly and consistently every time they have sex; and 4) Increase male youth's engagement with goals and dreams for their future.
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There are seven modules in Healthy U: Puberty, Birth Control, Teen Pregnancy, HIV, STDs, Healthy Relationships, and Condom Negotiation.
Each module has six sections: Introduction and Review, Narrative Teen Portrait, Information Film, Activity/Game, Dramatic Film, and Imagination Challenge.
The Introduction and Review has videos lasting 1-2 minutes where the Healthy U "host" introduces each module.
In the Narrative Teen Portrait for each module, a different teen discusses their experience with the topic for 1-3 minutes.
The Information Film lasts 5-18 minutes per module and provides factual information.
For each module, the Activity/Game includes multiple choice, true/false, or other games.
The Dramatic Film lasts 5-17 minutes for each module and shows a fictional account of a teen experiencing the topic.
Finally, the Imagination Challenge asks the youth to imagine a scenario, such as going to a health clinic to obtain free condoms.
Other Names:
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No Intervention: Treatment as usual
The counterfactual condition for the study is a business-as-usual condition.
OYA does not provide much programming to youth in its facilities related to sexual health and pregnancy prevention.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sexual intercourse
Time Frame: 6 months after the baseline survey
|
The outcome was based on four survey items.
Youth who responded "no" to the first item: "Have you ever had sexual intercourse?"
were coded as "0".
Youth who responded "no" to the second item: "Have you been out of a close custody OYA facility any time in the past three months?"
were also coded as "0".
Youth who responded "no" to the third item: "During the last 3 months, did you have sexual intercourse, even once?"
were also coded as "0".
Youth who responded "yes" to the first three items and provided a valid response greater than zero to the fourth item: "In the last 3 months (include only the time you were outside of a close custody OYA facility), how many TIMES did you have sexual inter-course?"
were coded as the value they entered.
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6 months after the baseline survey
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sexual intercourse without a condom
Time Frame: 6 months after the baseline survey
|
The outcome was created by subtracting the sexual intercourse outcome from the following measure based on four items.
Youth who responded "no" to the first item: "Have you ever had sexual intercourse?"
were coded as "0".
Youth who responded "no" to the second item: "Have you been out of a close custody OYA facility any time in the past three months?"
were also coded as "0".
Youth who responded "no" to the third item: "During the last 3 months, did you have sexual intercourse, even once?"
were also coded as "0".
Youth who responded "yes" to the first three items and provided a valid response greater than zero to the fourth item: "In the last 3 months (include only the time you were outside of a close custody OYA facility), how many TIMES did you or your partner use a condom when you had sexual inter-course?"
were coded as the value they entered.
Youth who responded "none" to the fourth item were coded as "0".
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6 months after the baseline survey
|
Sexual intercourse without any methods of birth control
Time Frame: 6 months after the baseline survey
|
The outcome was based on four survey items.
Youth who responded "no" to the first item: "Have you ever had sexual intercourse?"
were coded as "0".
Youth who responded "no" to the second item: "Have you been out of a close custody OYA facility any time in the past three months?"
were also coded as "0".
Youth who responded "no" to the third item: "During the last 3 months, did you have sexual intercourse, even once?"
were also coded as "0".
Youth who responded "yes" to the first three items and provided a valid response greater than zero to the fourth item: "In the last 3 months (include only the time you were outside of a close custody OYA facility), how many times did you have sexual intercourse without you or your partner using any methods of birth control (that is, you didn't use a condom or any other type of birth control shown in the blue box above)?" were coded as the value they entered.
Youth who responded "none" to the fourth item were coded as "0".
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6 months after the baseline survey
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Subsequent pregnancies of female partners
Time Frame: 6 months after the baseline survey
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The outcome was created by subtracting the number of pregnancies reported at baseline from the number of pregnancies reported at the 6-month follow-up.
At both time points, the measure was based on three questions.
Youth who responded "no" to the first item: "Have you ever had sexual intercourse?"
were coded as "0".
Youth who responded "no" or "don't know" to the second item: "To the best of your knowledge, have you ever gotten someone pregnant, even if no child was born?" were also coded as "0".
Youth who responded "yes" to the first two items and provided a valid response greater than zero to the third item: "To the best of your knowledge, how many times have you gotten someone pregnant?"
were coded as the value they entered.
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6 months after the baseline survey
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perceptions of condoms
Time Frame: 6 months after the baseline survey
|
The outcome was calculated as the average response based on a scale of 1 (strongly disagree) to 5 (strongly agree) for the following four items:
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6 months after the baseline survey
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Perceptions of sexual intercourse
Time Frame: 6 months after the baseline survey
|
The outcome was calculated as the average response based on a scale of 1 (strongly disagree) to 5 (strongly agree) for the following five items:
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6 months after the baseline survey
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Confidence in use of birth control
Time Frame: 6 months after the baseline survey
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The outcome was the response on a scale of 1 (not at all confident) to 5 (completely confident) for the following item: "How confident are you that your partner used one of the methods of birth control shown in the blue box to the right the last time you had sexual intercourse?"
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6 months after the baseline survey
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Intentions to use condoms
Time Frame: 6 months after the baseline survey
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The outcome was the response on a scale of 1 (no, definitely not) to 4 (yes, definitely) based on the following item: "If you were to have sexual intercourse in the next year, do you intend to use a condom?"
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6 months after the baseline survey
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Intentions to use birth control
Time Frame: 6 months after the baseline survey
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The outcome was the response on a scale of 1 (no, definitely not) to 4 (yes, definitely) based on the following item: "If you were to have sexual intercourse in the next year, do you intend to have your partner use any of the methods of birth control shown in the blue box to the right?"
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6 months after the baseline survey
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Knowledge about condoms
Time Frame: 6 months after the baseline survey
|
The outcome was calculated as the average response based on a scale of 1 (not at all) to 3 (a lot) for the following three items: If a condom is used correctly, how much can it decrease the risk of…
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6 months after the baseline survey
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 8169
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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