Personal Responsibility Education Program Innovative Strategies: Digital Initiative for Youth (PREIS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03765255|
Recruitment Status : Active, not recruiting
First Posted : December 5, 2018
Last Update Posted : February 15, 2021
|Condition or disease||Intervention/treatment||Phase|
|Reproductive Health Contraception Sexually Transmitted Diseases||Other: In the Know: sexual health education||Not Applicable|
The Digital Initiative for Youth (DIY) is an innovative, youth-centered, digital intervention that aims to improve the health and well-being of adolescents ages 13-19 in Fresno County, California. In particular, it will address the needs of homeless and unstably housed youth, youth of color, sexual minority youth, and Native American youth using a trauma-informed approach and positive youth development framework.
DIY combines existing, in-person, group-based, comprehensive sexual health education with an app designed in consultation with youth. DIY is built on three strategies: positive youth development, youth-centered design, and wraparound technologies. It will focus on four main areas: sexual health and contraceptive use, healthy relationships, educational and career development, and life skills. The intervention includes six hours of in-person education and an app that includes a resource locator, goal setting, text message reminders, and additional information and referrals.
This study is funded through the Personal Responsibility Education Program Innovative Strategies (PREIS), which is administered by the Family and Youth Services Bureau, part of Health and Human Services,
Fresno EOC is responsible for site and participant recruitment as well as the implementation of the intervention. Participants are randomized at the cohort (group) level. All control group participants will be invited to participate after completion of the long-term follow up period.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1260 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Adolescents will be randomly assigned to treatment or control by cohort (groups of 5-25 adolescents). Adolescents will consent to participation and complete baseline survey prior to randomization. Enrollment will continue by cohort for approximately 2 years. Approximately 15 sites will participate with 2-4 cohorts per site per year.|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||The adolescents and the staff enrolling the participants will not know of study assignment until after completing recruitment, consent, and baseline. At that point, they will open an envelope stating if it is a control or treatment cohort. The researcher conducting the outcomes analysis will not know enrollment status of an individual.|
|Official Title:||Personal Responsibility Education Program Innovative Strategies: Digital Initiative for Youth; An Innovative Youth-Centered Initiative to Improve the Sexual Health and Socio-Economic Well-Being of Youth in Fresno County, California|
|Actual Study Start Date :||October 17, 2017|
|Estimated Primary Completion Date :||March 30, 2021|
|Estimated Study Completion Date :||September 30, 2021|
Experimental: In the Know (ITK): sexual health education
Cohorts/participants in the experimental (treatment) arm receive an intervention that combines 6 hours of in-person sexual health and adolescent development education with an app that includes a resource locator, text message reminders (for one month), goal setting, and other resources.
Other: In the Know: sexual health education
The in-person sessions include modules on: sexual and reproductive health (2 hours - anatomy, gender and sexual orientation, pregnancy, contraception, sexually transmitted infections); healthy relationships and life skills (2 hours - communication and negotiation, consent, violence, online dating, goal setting, strengths); and educational and career success (2 hours - educational and career options, applying for scholarships and financial aid, job readiness, resume preparation, interview skills). The app includes: online referrals, personal life plans/goal setting, text message reminders, quizzes, and other resources.
No Intervention: Control: do not receive ITK intervention
Cohorts/participants in the no intervention arm do not receive either the in-person education or the app. However, after completing the 10 month survey, they will have access to the app and will be invited to participate in the in-person program after the study implementation phase is completed (years 4 and 5).
- Self-reported condom/contraceptive use or no sex in the last three months on survey [ Time Frame: Short term follow up (3 months) ]Answered some or all of the time to: In the past 3 months, how often did you or a partner use birth control when you had vaginal sex OR In the past 3 months, how often did you use condoms when you had anal sex? Respondents complete computer-based survey. Survey developed by University of California, San Francisco (UCSF).
- Self-reported use of any clinic services in the last three months on survey [ Time Frame: Long-term follow up (9 months) ]Checked any services from survey list after question, "Please check all of the services you have received from a doctor, counselor, therapist, social worker, or clinic in the past 3 months." Respondents complete computer-based survey. Survey developed by UCSF.
- Self-reported sexual risk behavior on survey [ Time Frame: Short-term follow up (3 months) ]Respondents provide number of sexual partners in past 3 months on computer-based survey. Survey developed by UCSF.
- Self-reported knowledge of local clinical services on survey [ Time Frame: Short-term follow up (3 months) ]Answered yes to question on computer-based survey: "Have you heard of a clinic or doctor in your community where teens can get sexual health information and services such as condoms, birth control, pregnancy tests, STI tests/treatment, and/or HIV tests?" Survey developed by UCSF.
- Self-reported healthy relationship skills on survey [ Time Frame: Short-term follow up (3 months) ]Increased number of correct answers on knowledge about healthy relationships questions on computer-based survey between baseline and short-term follow up. Survey developed by UCSF.
- Self-reported career and education skills on survey [ Time Frame: Long-term follow up (9 months) ]Respondents answer they are or have been enrolled in career training, internships, or educational support. Respondents complete computer-based survey. Survey developed by UCSF.
- Self-reported goal setting skills on survey [ Time Frame: Short-term follow up (3 months) ]Aggregate responses to "worked on an educational and/or career goal" and "made plans to reach your goals" on computer-based survey. Survey developed by UCSF.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03765255
|United States, California|
|Fresno Economic Opportunities Commission|
|Fresno, California, United States, 93701|
|Principal Investigator:||Mara J Decker, DrPH||University of California, San Francisco|