Clinical trial NCT04027010: An Evaluation of Virtual Student Health Center Among Incarcerated Juvenile Offenders
Official title: A Randomized Controlled Trial of Virtual Student Health Center Among Incarcerated Juvenile Offenders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lack of Knowledge About Condoms and Birth Control
Adolescent Sexual Intercourse
Sexual Intercourse Without a Condom or Birth Control
Unplanned Pregnancies
Keywords: juvenile justice
male-focused intervention
unplanned teen fatherhood
technology-based intervention
Lead sponsor: WestEd
Sponsor class: OTHER
Collaborators: name: Oregon Youth Authority
name: Efficacity
name: The Office of Adolescent Health, HHS
First posted: 2019-07-19
Enrollment: 295
Sex: MALE
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The treatment condition involves participation in a teen pregnancy prevention program, Healthy U (formally known as Virtual Student Health Center). The comparison condition for the study is treatment as usual.
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Sexual intercourse
timeFrame: 6 months after the baseline survey
Secondary outcomes:
measure: Sexual intercourse without a condom
timeFrame: 6 months after the baseline survey
measure: Sexual intercourse without any methods of birth control
timeFrame: 6 months after the baseline survey
measure: Subsequent pregnancies of female partners
timeFrame: 6 months after the baseline survey
Other outcomes:
measure: Perceptions of condoms
timeFrame: 6 months after the baseline survey
measure: Perceptions of sexual intercourse
timeFrame: 6 months after the baseline survey
measure: Confidence in use of birth control
timeFrame: 6 months after the baseline survey
measure: Intentions to use condoms
timeFrame: 6 months after the baseline survey
measure: Intentions to use birth control
timeFrame: 6 months after the baseline survey
measure: Knowledge about condoms
timeFrame: 6 months after the baseline survey
Locations:
city: Los Alamitos
country: United States
facility: WestEd
state: California
city: Woburn
country: United States
facility: WestEd
state: Massachusetts
Study officials:
References:
citation: 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. doi: 10.1037/0278-6133.24.2.133.