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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-27
SponsorCity University of New York, School of Public Health

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

16-27 years of age

resides in New York State

mild/moderate I/DD

willing to receive either STEPS2 or STYH curricula

Disqualifiers

if female sex, self-reports pregnant at screening

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

856 Participants
are divided into 2 treatment groups
Group A: Socialization and sex education (STEPS2)Experimental treatment 1 intervention
Group B: Nutrition and physical activity (STYH)Other 1 intervention

Trial outcomes

Primary outcomes

1

Proportion who have had a sexual health discussion with medical professional

Have had a sexual health discussion with medical professional

Time frame
One year post enrollment
2

Proportion who know their HPV vaccination status

Know whether they have been vaccinated for HPV

Time frame
One year post enrollment
3

Proportion who have been vaccinated for HPV

Have been vaccinated for HPV (self-report with verification using NYS and NYC immunization registry when possible)

Time frame
One year post enrollment
4

Proportion who can accurately describe what sex is

Understand what sex is based on response to an open-ended question

Time frame
One year post enrollment

Secondary outcomes

1

Average sexual health knowledge score (1-25, with 25 being high knowledge)

Score based on sexual health knowledge survey questions

Time frame
One year post enrollment
2

Average sexual health knowledge score (1-25, with 25 being high knowledge)

Score based on sexual health knowledge survey questions

Time frame
6 months post enrollment
3

Average sexual health knowledge score (1-25, with 25 being high knowledge)

Score based on sexual health knowledge survey questions

Time frame
Two months post enrollment (after completion of 6 week intervention)
4

Proportion using birth control among those reporting vaginal sex

Self-reported use of birth control among those reporting vaginal sex

Time frame
One year post enrollment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

City University of New York, School of Public Health

Lead sponsor

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

Collaborator

National Institutes of Health INCLUDE Project

Collaborator

National Institutes of Health Office of Disease Prevention

Collaborator