Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-26 @ 10:57 AM
NCT ID:
NCT04079608
Eligibility Criteria:
Inclusion criteria was determined at three levels:
* District level eligibility: Districts must have been from regions with teen birth rates at or above the national average at the time of study recruitment. They also much have agreed with randomization of mainstream schools to either High School FLASH or the five-session knowledge-based comparison condition. We worked with 7 different districts in two different regions of the U.S. - the Midwest (2 districts) and the South (5 districts).
* School level eligibility: Schools were eligible to participate if they: (1) agreed with inviting all students in targeted grade level in the fall semester required class to take part in the study (9th or 10th grades depending on health education course placement); (2) had a policy environment that enabled implementation of all FLASH components if randomized to intervention condition; (3) were in a district not currently mandating comprehensive sexuality education or using an evidence-based sexual health curriculum in school or for after-school programs; and (4) have schools large enough to ideally contribute 40 or more students to the study.
* Student level eligibility: Student enrollment into the study must have included (1) being in targeted classes during the enrollment window (fall semester 2016 in the Midwest and fall semester 2017 in the South), (2) providing positive parent consent to take part in study survey; and (3) providing assent to take part in the survey.
Exclusion Criteria:
* Anyone not meeting inclusion criteria
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
14 Years
Maximum Age:
18 Years
Study:
NCT04079608
Study Brief:
Protocol Section:
NCT04079608