Socialization To Enrich Participation & Support Sexuality for Young People With I/DD

Part of paid clinical trials in New York, New York.

Sponsor
City University of New York, School of Public Health
Study ID
NCT06231485
Status
Recruiting
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Conditions

  • Behavior
  • Knowledge

Eligibility Criteria

Sex
ALL
Age
16 Years - 27 Years
Healthy Volunteers
Accepted

Interventions

  • STEPS2 — BEHAVIORAL
    One of the two health education curricula as described in arm/group descriptions.
  • STYH — BEHAVIORAL
    One of the two health education curricula as described in arm/group descriptions.

Study Details

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.

Key Dates

Start date
Oct 20, 2023
Status verified
Jan 2024
Primary completion
Feb 28, 2027
Completion
Feb 28, 2027

Study Design

Enrollment
856 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Socialization and sex education (STEPS2)
    Weekly virtual one hour one-on-one sessions with Study Health Educator on the STEPS2 curriculum for 6-weeks. Topics include: the human body, decision-making, sexually transmitted diseases, pregnancy, birth control, pregnancy and parenting, and going to the doctor.
  • Other: Nutrition and physical activity (STYH)
    The comparison curriculum has been shown in a previous study to improve knowledge around nutrition and exercise, but should not change sexual and reproductive health outcomes. Weekly virtual one hour group sessions (6-10 participants) with Study Health Educator on the Steps To Your Health (STYH) curriculum for 6-weeks. Topics include: nutrition, exercise, stress management, changing your way of thinking, and behaviors to stay healthy.

Primary Outcome Measure

Proportion who have had a sexual health discussion with medical professional [ Time Frame: One year post enrollment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
CUNY School of Public Health (but interventions are virtual)New YorkNew York10027
Vanessa Colon
[email protected]

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By research site
CUNY School of Public Health (but interventions are virtual)· New York, NY

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