Recruiting

STEPS2

Sponsor:

City University of New York, School of Public Health

Code:

NCT06231485

Conditions

Knowledge

Behavior

Eligibility Criteria

Sex: All

Age: 16 - 27

Healthy Volunteers: Accepted

Interventions

STEPS2

STYH

Study Details

Brief 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

Study ID

NCT06231485

Start date

Oct 20, 2023

Status verified date

Oct, 2026

Completion date

Feb, 2027

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16 - 27

Healthy Volunteers: Accepted

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

Study Design

Enrollment

856 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Socialization and sex education (STEPS2)

Weekly virtual one hour one-on-one sessions with Study Health Educator on the STEPS2 curriculum for 6-weeks. Topics include: the human body, decision-making, sexually transmitted diseases, pregnancy, birth control, pregnancy and parenting, and going to the doctor.

other: Nutrition and physical activity (STYH)

The comparison curriculum has been shown in a previous study to improve knowledge around nutrition and exercise, but should not change sexual and reproductive health outcomes.

Weekly virtual one hour group sessions (6-10 participants) with Study Health Educator on the Steps To Your Health (STYH) curriculum for 6-weeks. Topics include: nutrition, exercise, stress management, changing your way of thinking, and behaviors to stay healthy.

Interventions

STEPS2

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

STYH

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

Primary outcome measure

  • Proportion who have had a sexual health discussion with medical professional [ Time Frame: One year post enrollment ]
  • Proportion who know their HPV vaccination status [ Time Frame: One year post enrollment ]
  • Proportion who have been vaccinated for HPV [ Time Frame: One year post enrollment ]
  • Proportion who can accurately describe what sex is [ Time Frame: One year post enrollment ]
  • Proportion who can accurately describe how a person gets pregnant [ Time Frame: One year post enrollment ]

Central Contacts and Locations

Central contacts

Locations

CUNY School of Public Health (but interventions are virtual)

Recruiting

New York, New York, United States, 10027

Contacts

More Information

Sponsor

City University of New York, School of Public Health

Last update posted

Oct 21, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-22. This information was provided to ClinicalTrials.gov by City University of New York, School of Public Health on 2026-10-21. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.