NCT06231485 · City University of New York, School of Public Health
Socialization To Enrich Participation & Support Sexuality for Young People With I/DD
(STEPS2)
What this study 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.
View original scientific description
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.
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.
Primary outcome measures
Proportion who have had a sexual health discussion with medical professional
Time frame: One year post enrollment
Have had a sexual health discussion with medical professional
Proportion who know their HPV vaccination status
Time frame: One year post enrollment
Know whether they have been vaccinated for HPV
Proportion who have been vaccinated for HPV
Time frame: One year post enrollment
Have been vaccinated for HPV (self-report with verification using NYS and NYC immunization registry when possible)
Proportion who can accurately describe what sex is
Time frame: One year post enrollment
Understand what sex is based on response to an open-ended question
Proportion who can accurately describe how a person gets pregnant
Time frame: One year post enrollment
Can describe that vaginal sex can lead to pregnancy and the general mechanics of how this works in an open-ended question
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- New York, New York
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health INCLUDE Project, National Institutes of Health Office of Disease Prevention
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 30, 2024 · Source of record for eligibility and locations