NCT06231485 Socialization To Enrich Participation & Support Sexuality for Young People With I/DD
| NCT ID | NCT06231485 |
| Status | Recruiting |
| Phase | — |
| Sponsor | City University of New York, School of Public Health |
| Condition | Knowledge |
| Study Type | INTERVENTIONAL |
| Enrollment | 856 participants |
| Start Date | 2023-10-20 |
| Primary Completion | 2027-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 856 participants in total. It began in 2023-10-20 with a primary completion date of 2027-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to test the effectiveness of a 6-week socialization and sex education curriculum (STEPS2) in young people (aged 16-27 years) with intellectual and developmental disabilities (I/DD), including people with Down syndrome. The main question it aims to answer is: Does the STEPS2 health education curriculum increase the proportion of individuals who: 1. have had a discussion with a medical professional about their sexual health (including sexually transmitted infection testing for those who are sexually active); 2. know whether they have had the HPV vaccination; 3. have had the HPV vaccination; 4. know what sex is; and 5. know how people get pregnant. These are the primary outcomes which are being measured one year after study enrollment. Secondary outcomes include knowledge around sexual health and behaviors around contraception and STI prevention among those sexually active at baseline, as well as satisfaction with the intervention. Participants are randomized to receive either the socialization and sex education curriculum in the experimental group, called the STEPS2 curriculum, or a nutrition and physical exercise curriculum in the comparison group, called Steps To Your Health (STYH). Participants in the STEPS2 experimental group meet with a health educator in one-on-one individually tailored sessions virtually once a week for one hour for 6 weeks. Participants in the STYH comparison group meet with a health educator in small group sessions of 6-10 participants virtually once a week for one hour for 6 weeks. Researchers will compare sexual and reproductive health knowledge and behaviors one year after study enrollment to see if the STEPS2 curriculum is effective at increasing knowledge and healthy behaviors.
Eligibility 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
Contact & Investigator
Suzanne McDermott, PhD
PRINCIPAL INVESTIGATOR
CUNY School of Public Health
Frequently Asked Questions
Who can join the NCT06231485 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, up to 27 Years, studying Knowledge. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06231485 currently recruiting?
Yes, NCT06231485 is actively recruiting participants. Contact the research team at heidi.jones@sph.cuny.edu for enrollment information.
Where is the NCT06231485 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT06231485 clinical trial?
NCT06231485 is sponsored by City University of New York, School of Public Health. The principal investigator is Suzanne McDermott, PhD at CUNY School of Public Health. The trial plans to enroll 856 participants.