NCT04027010

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
295

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

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

February 1, 2017

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

July 17, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 19, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

August 10, 2022

Status Verified

August 1, 2022

Enrollment Period

3.2 years

First QC Date

July 17, 2019

Last Update Submit

August 9, 2022

Conditions

Keywords

juvenile justicemale-focused interventionunplanned teen fatherhoodtechnology-based intervention

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Sexual intercourse without a condom

    6 months after the baseline survey

  • Sexual intercourse without any methods of birth control

    6 months after the baseline survey

  • Subsequent pregnancies of female partners

    6 months after the baseline survey

Other Outcomes (6)

  • Perceptions of condoms

    6 months after the baseline survey

  • Perceptions of sexual intercourse

    6 months after the baseline survey

  • Confidence in use of birth control

    6 months after the baseline survey

  • +3 more other outcomes

Study Arms (2)

"Healthy U" tablet application

EXPERIMENTAL

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.

Other: "Healthy U" tablet application

Treatment as usual

NO INTERVENTION

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.

Interventions

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.

Also known as: Virtual Student Health Center
"Healthy U" tablet application

Eligibility Criteria

Age14 Years - 19 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsThe study sample will include male youth who, at the time of recruitment, are incarcerated in one of the five OYA male juvenile justice facilities.
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

WestEd

Los Alamitos, California, 90720, United States

Location

WestEd

Woburn, Massachusetts, 01801, United States

Location

Related 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. doi: 10.1037/0278-6133.24.2.133.

    PMID: 15755227BACKGROUND

Study Design

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

Study Record Dates

First Submitted

July 17, 2019

First Posted

July 19, 2019

Study Start

February 1, 2017

Primary Completion

May 1, 2020

Study Completion

May 1, 2020

Last Updated

August 10, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations