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

City University of New York, School of Public Health · with Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health INCLUDE Project · NCT06231485

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 16–27 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
856
US sites recruiting
1
Study start
October 20, 2023
Record last updated
October 21, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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:

  • have had a discussion with a medical professional about their sexual health (including sexually transmitted infection testing for those who are sexually active);
  • know whether they have had the HPV vaccination;
  • have had the HPV vaccination;
  • know what sex is; and
  • 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.

Being studied: STEPS2; STYH

Conditions: Knowledge; Behavior

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • CUNY School of Public Health (but interventions are virtual)

    New York, NY 10027

    Site contact: Louie Cao · louie.cao@sph.cuny.edu

Study contacts (from the official record)

  • Heidi E Jones, PhD · 646-364-9529 · heidi.jones@sph.cuny.edu
  • Suzanne McDermott, PhD · suzanne.mcdermott@sph.cuny.edu
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Socialization To Enrich Participation & Support Sexuality for… (NCT06231485) | Bored Studies