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NCT06231485 · ClinicalTrials.gov registry record · NA
Socialization To Enrich Participation & Support Sexuality for Young People With I/DD
A NA study of Behavior and Knowledge, sponsored by City University of New York, School of Public Health.
- Recruiting
- Registry status
- NA
- Development phase
- 856
- Enrollment target
- 1
- Study location
NCT06231485: Recruiting NA study of Behavior and Knowledge, sponsored by City University of New York, School of Public Health.
NCT06231485 is a NA study of Behavior and Knowledge that is actively recruiting participants, run by City University of New York, School of Public Health. The registered enrollment target is 856 participants, below the 4,828-participant average among 23 other Behavior trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06231485, a NA study of Behavior and Knowledge, is actively recruiting participants, sponsored by City University of New York, School of Public Health.
- RECRUITING
- Registry status
- NA
- Development phase
- 856 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Have had a sexual health discussion with medical professional
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 |
What NCT06231485 shows while recruiting
NCT06231485 is an interventional study that assigns participants to a tested intervention. The registered 856 participants enrollment target is mid-sized for trials with a published cap, below the 4,828-participant average among 23 other Behavior trials with a reported enrollment target (82% lower).
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.
NCT06231485 reports a single indexed study location in New York.
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.
What interventions are being tested in trial NCT06231485?
The interventions under investigation include: STEPS2 (BEHAVIORAL), STYH (BEHAVIORAL).
Who is sponsoring clinical trial NCT06231485?
This trial is sponsored by City University of New York, School of Public Health, which has 10 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06231485's enrollment target sits among peer trials
856 7th of 23 higher than 17 of 23 other Behavior trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Behavior trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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