Adolescent Sexual Intercourse Clinical Trial
Official title:
A Randomized Controlled Trial of Virtual Student Health Center Among Incarcerated Juvenile Offenders
NCT number | NCT04027010 |
Other study ID # | 8169 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | February 1, 2017 |
Est. completion date | May 1, 2020 |
Verified date | August 2022 |
Source | WestEd |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | WestEd | Los Alamitos | California |
United States | WestEd | Woburn | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
WestEd | Efficacity, Oregon Youth Authority, The Office of Adolescent Health, HHS |
United States,
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
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 |