Actively Recruiting

Phase Not Applicable
Age: 16Years - 27Years
All Genders
Healthy Volunteers
NCT06231485

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

Led by City University of New York, School of Public Health · Updated on 2024-01-30

856

Participants Needed

1

Research Sites

171 weeks

Total Duration

On this page

Sponsors

C

City University of New York, School of Public Health

Lead Sponsor

E

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborating Sponsor

AI-Summary

What this Trial 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: 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 16Years - 27Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 16 and 27 years
  • Lives in New York State
  • Has mild or moderate intellectual or developmental disabilities
  • Willing to receive either the STEPS2 or STYH curriculum
  • Able to complete the curriculum in English
Not Eligible

You will not qualify if you...

  • If female, currently pregnant at screening

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

CUNY School of Public Health (but interventions are virtual)

New York, New York, United States, 10027

Actively Recruiting

Loading map...

Research Team

H

Heidi E Jones, PhD

CONTACT

S

Suzanne McDermott, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

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