Socialization and sex education for young people with intellectual and developmental disabilities
A Randomized Intervention Trial to Increase Access to Reproductive Health Services Among Adolescents and Young Adults With Intellectual and Developmental Disabilities
This study is testing a new 6-week program to teach young people with intellectual and developmental disabilities about social skills and sexual health to see if it helps them understand these topics better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 856 (estimated) |
| Ages | 16 Years to 27 Years |
| Sex | All |
| Sponsor | City University of New York, School of Public Health Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06231485 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a 6-week socialization and sex education curriculum called STEPS2 for young people aged 16-27 with intellectual and developmental disabilities (I/DD), including those with Down syndrome. Participants will be randomly assigned to either the STEPS2 curriculum or a comparison curriculum (STYH) and will engage in weekly virtual health education sessions. The study aims to measure improvements in sexual health knowledge and behaviors, including discussions with healthcare professionals and awareness of vaccinations. Outcomes will be assessed one year after enrollment to determine the curriculum's impact on participants' sexual health education.
Who should consider this trial
Good fit: Ideal candidates are young individuals aged 16-27 with mild to moderate intellectual or developmental disabilities residing in New York State.
Not a fit: Patients who are pregnant or do not meet the age or residency criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve sexual health knowledge and behaviors among young people with I/DD.
How similar studies have performed: While similar educational interventions have shown promise, this specific approach targeting young people with I/DD is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 16-27 years of age * resides in New York State * mild/moderate I/DD * willing to receive either STEPS2 or STYH curricula * able to complete curriculum in English Exclusion Criteria: * if female sex, self-reports pregnant at screening
Where this trial is running
New York, New York
- CUNY School of Public Health (but interventions are virtual) — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Suzanne McDermott, PhD — CUNY School of Public Health
- Study coordinator: Heidi E Jones, PhD
- Email: heidi.jones@sph.cuny.edu
- Phone: 646-364-9529
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.