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

Summary

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

• Knowledge
• Behavior

Interventions

BEHAVIORAL

STEPS2

One of the two health education curricula as described in arm/group descriptions.

BEHAVIORAL

STYH

One of the two health education curricula as described in arm/group descriptions.

Sponsors & Collaborators

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

  collaborator NIH

• National Institutes of Health INCLUDE Project

  collaborator UNKNOWN

• National Institutes of Health Office of Disease Prevention

  collaborator UNKNOWN

• City University of New York, School of Public Health

  lead OTHER

Principal Investigators

• Suzanne McDermott, PhD · CUNY School of Public Health

• Heidi E Jones, PhD · CUNY School of Public Health

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

16 Years

Max Age

27 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-10-20

Primary Completion

2027-02-28

Completion

2027-02-28

Countries

• United States

Study Locations