Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Socialization To Enrich Participation & Support Sexuality for Young People With I/DD
NCT06231485 · View on ClinicalTrials.gov ↗
Study 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.
Interventions
- BEHAVIORAL STEPS2
- BEHAVIORAL STYH
Study Locations (1)
New York
- CUNY School of Public Health (but interventions are virtual) — New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 856 participants |
| Start Date | 2023-10-20 |
| Est. Completion | 2027-02 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06231485
The ClinicalTrials.gov registry entry for NCT06231485 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 856 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is City University of New York, School of Public Health, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Behavior appearing as the primary indexed condition, and to 2 interventions — of which STEPS2 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06231485 reports 1 study location spanning 1 distinct geographic area — top geographies include New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06231485 about?
NCT06231485 is a clinical study titled "Socialization To Enrich Participation & Support Sexuality for Young People With I/DD". 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...
What is the current status of trial NCT06231485?
This trial is currently recruiting. It is a NA study. The enrollment target is 856 participants. The study started on 2023-10-20. Estimated completion is 2027-02.
What conditions does trial NCT06231485 study?
This clinical trial studies the following conditions: Behavior, Knowledge. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06231485?
The interventions under investigation include: STEPS2 (BEHAVIORAL), STYH (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06231485?
This trial is sponsored by City University of New York, School of Public Health, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06231485 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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