An Evaluation of Virtual Student Health Center Among Incarcerated Juvenile Offenders

Adolescent Sexual Intercourse Clinical Trial

Official title:

A Randomized Controlled Trial of Virtual Student Health Center Among Incarcerated Juvenile Offenders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04027010
• Other study ID #: 8169
• Status: Completed
• Phase: N/A
• Start date: February 1, 2017
• Est. completion date: May 1, 2020

Study information

• Verified date: August 2022
• Source: WestEd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

WestEd and its partners Efficacity and the Oregon Youth Authority (OYA), are conducting a randomized controlled trial of an innovative teen pregnancy prevention program, Healthy U, for youthful male offenders. This study involves male teenagers (age 14-19) at high risk for involvement in risky sexual behavior, including teen pregnancy. The innovative, non-curricular, technology-based intervention, Healthy U, is self-directed, low-cost, user friendly, and offers great promise in reaching incarcerated youth. The purpose of this study is to test this intervention on a population of young men incarcerated at the OYA who will soon be released into the community. The intervention is tailored to this population by updating the design, videos, and examples to best reflect the youth in the study, and OYA staff are being trained to facilitate the self-guided intervention.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 295
• Est. completion date: May 1, 2020
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 14 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Sexual Intercourse
• Lack of Knowledge About Condoms and Birth Control
• Sexual Intercourse Without a Condom or Birth Control
• Unplanned Pregnancies

Intervention

Other:
• "Healthy U" tablet application
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.

Locations

Country	Name	City	State
United States	WestEd	Los Alamitos	California
United States	WestEd	Woburn	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
WestEd	Efficacity, Oregon Youth Authority, The Office of Adolescent Health, HHS

Country where clinical trial is conducted

United States, 

References & Publications (1)

Bryan A, Rocheleau CA, Robbins RN, Hutchinson KE. Condom use among high-risk adolescents: testing the influence of alcohol use on the relationship of cognitive correlates of behavior. Health Psychol. 2005 Mar;24(2):133-42. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Perceptions of condoms	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: Condoms should always be used if a person your age has sexual intercourse.; Condoms are a hassle to use.; Condoms are important to make sex safer.; Using condoms means you don't trust your sexual partner. Youth needed to complete three of the four items to be included in the calculation.	6 months after the baseline survey
Other	Perceptions of sexual intercourse	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: Having sexual intercourse is a good thing for you to do at your age. (Reverse coded); At your age right now, having sexual intercourse would create problems.; At your age right now, not having sexual intercourse is important for you to be safe and healthy.; At your age right now, it is okay for you to have sexual inter-course if you use birth control, like a condom. (Reverse coded); It is against your values to have sexual intercourse before marriage.	6 months after the baseline survey
Other	Confidence in use of birth control	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?"	6 months after the baseline survey
Other	Intentions to use condoms	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?"	6 months after the baseline survey
Other	Intentions to use birth control	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?"	6 months after the baseline survey
Other	Knowledge about condoms	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…; Pregnancy?; Getting HIV, the virus that causes AIDS?; Getting chlamydia and gonorrhea? Responses of "don't know", which represented less than 6% of the data, were treated as missing. Youth needed to complete two of the three items to be included in the calculation.	6 months after the baseline survey
Primary	Sexual intercourse	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.	6 months after the baseline survey
Secondary	Sexual intercourse without a condom	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".	6 months after the baseline survey
Secondary	Sexual intercourse without any methods of birth control	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".	6 months after the baseline survey
Secondary	Subsequent pregnancies of female partners	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.	6 months after the baseline survey