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

Recruiting now · Not applicable

Conditions studied: Knowledge, Behavior

In brief

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 facts

Study ID

NCT06231485

Run by

City University of New York, School of Public Health

People needed

856

Starts

2023-10-20

Expected to finish

2027-02-01

Last updated by the study team

2024-01-30

Who can join

Age: 16 and older, up to 27. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• if female sex, self-reports pregnant at screening

Where it is running

• CUNY School of Public Health (but interventions are virtual) — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.