KnowledgeSTEPS2NCT06231485
Socialization To Enrich Participation & Support Sexuality for Young People With I/DD
A study testing STEPS2 and STYH in people with Knowledge and Behavior, run by City University of New York, School of Public Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 27 yearsHealthy volunteers can take part
- What is being tested?
- STEPS2 and STYH
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 856 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2023to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 27 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- if female sex, self-reports pregnant at screening
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Suzanne McDermott, PhD contact
United States1 site, 1 recruiting
- Recruiting
CUNY School of Public Health (but interventions are virtual)
New York, New York, 10027
Louie Cao, louie.cao@sph.cuny.edu
Vanessa Colon, vanessa.colon@sph.cuny.edu
About this study
Official title: A Randomized Intervention Trial to Increase Access to Reproductive Health Services Among Adolescents and Young Adults With Intellectual and Developmental Disabilities
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:
Read more
Does the STEPS2 health education curriculum increase the proportion of individuals who:
- have had a discussion with a medical professional about their sexual health (including sexually transmitted infection testing for those who are sexually active);
- know whether they have had the HPV vaccination;
- have had the HPV vaccination;
- know what sex is; and
- 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.
Read the detailed description
The goal of this clinical trial is to test the effectiveness of a 6-week socialization and sex education curriculum (STEPS2) among 856 adolescent and young adults (aged 16-27 years) with mild to moderate intellectual or developmental disabilities (I/DD), including people with Down syndrome.
The investigators are recruiting participants through collaboration with the New York State Office of People with Developmental Disabilities (OPWDD), Service Providers, Care Coordination Organizations and special programs, such as the Special Olympics. For participants who meet eligibility criteria and have consented or assented (as appropriate), a video call meeting is arranged to complete the baseline interview survey of socio-demographic characteristics and sexual and reproductive health knowledge and behaviors. The interview takes up to 45 minutes to complete. Once the baseline interview is completed the participant is randomly assigned to either the STEPS2 or the STYH arm of the study. Half of the participants will be randomized to STEPS2, and half to the STYH arm. Participants begin the intervention within 2 weeks of having completed the baseline survey.
For the intervention, participants in both arms receive virtual video call one hour weekly health education sessions for 6 weeks. The STEPS2 socialization and sexuality curriculum (experimental arm) is provided during one-on-one sessions between a Study Health Educator and the participant. The STYH curriculum (comparison arm) is provided during group sessions with 6-10 participants and a Study Health Educator. For both arms, participants choose whether they wish for a guardian or helper to also attend for a given session.
Participants have follow-up interview surveys at month 2 (after completing the health education intervention), month 6, and month 12, with the same sexual and reproductive health measures as included in the baseline survey. The month 2 interviews also include measures of participant satisfaction with the curriculum and with the Study Health Educator. Each survey takes up to 45 minutes to complete. Survey interviewers are blinded to which curriculum participants have received.
The investigators are comparing the proportion of participants who have had a conversation with a doctor about sex, know their HPV vaccination status, have had the HPV vaccine, and show an understanding of sex and pregnancy at the month 12 interview between the two arms, after adjusting for baseline measures of these indicators, to test whether participation in the STEPS2 arm had an effect on these measures. Analysis will include intention-to-treat estimates, as well as instrumental variable estimates to adjust for incomplete attendance to the 6-week curricula. Analyses will also be stratified by gender, age, and mild versus moderate I/DD.
If the STEPS2 curriculum is found to improve reproductive and sexual health knowledge and behaviors, the investigators will email the curriculum to all participants in the STYH arm at study completion. Both curricula will be made publicly available at the end of the study.
- Being tested
- STEPS2, STYH
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STEPS2Behavioural
One of the two health education curricula as described in arm/group descriptions.
STYHBehavioural
One of the two health education curricula as described in arm/group descriptions.
| Study group | Role | What they receive |
|---|---|---|
| Socialization and sex education (STEPS2) | Experimental | 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. Receives: Behavioral: STEPS2 |
| Nutrition and physical activity (STYH) | Other | 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. Receives: Behavioral: STYH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion who have had a sexual health discussion with medical professional
Have had a sexual health discussion with medical professional
Measured: One year post enrollment
Proportion who know their HPV vaccination status
Know whether they have been vaccinated for HPV
Measured: One year post enrollment
Proportion who have been vaccinated for HPV
Have been vaccinated for HPV (self-report with verification using NYS and NYC immunization registry when possible)
Measured: One year post enrollment
Proportion who can accurately describe what sex is
Understand what sex is based on response to an open-ended question
Measured: One year post enrollment
Proportion who can accurately describe how a person gets pregnant
Can describe that vaginal sex can lead to pregnancy and the general mechanics of how this works in an open-ended question
Measured: One year post enrollment
Secondary outcomes (7)
Average sexual health knowledge score (1-25, with 25 being high knowledge)
Score based on sexual health knowledge survey questions
Measured: One year post enrollment
Average sexual health knowledge score (1-25, with 25 being high knowledge)
Score based on sexual health knowledge survey questions
Measured: 6 months post enrollment
Average sexual health knowledge score (1-25, with 25 being high knowledge)
Score based on sexual health knowledge survey questions
Measured: Two months post enrollment (after completion of 6 week intervention)
Proportion using birth control among those reporting vaginal sex
Self-reported use of birth control among those reporting vaginal sex
Measured: One year post enrollment
Proportion using condoms among those reporting vaginal and/or anal sex
Self-reported use of condoms among those reporting vaginal and/or anal sex
Measured: One year post enrollment
Proportion tested for STDs among those reporting vaginal and/or anal sex
Self-reported STD testing among those reporting vaginal and/or anal sex
Measured: One year post enrollment
Average satisfaction with intervention score (1 to 5, with 5 being very satisfied)
Average of self-reported satisfaction with 1. curriculum, 2. health educator and 3. participant manual (on a scale of 1 to 5 for each question)
Measured: Two months post enrollment (after completion of 6 week intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start20 Oct 2023
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KnowledgeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Half of the participants will be randomized to receive the socialization and sex education curriculum (STEPS2), and half to the nutrition and physical exercise curriculum (STYH)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 856 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City University of New York, School of Public Health
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Heidi Jones, City University of New York, School of Public Health
- Investigators
- Suzanne McDermott, PhD, Principal investigator, CUNY School of Public HealthHeidi E Jones, PhD, Principal investigator, CUNY School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06231485
- Sponsor's protocol ID
- 2022-0617
- Other IDs
- 1R01HD111044-01
- Acronym
- STEPS2
- Status last verified
- Oct 2026
- First submitted
- 20 Sep 2023
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized survey data from baseline, month 2, 6 and 12 will be made available for other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Intervention Trial to Increase Access to Reproductive Health Services Among Adolescents and Young Adults With Intellectual and Developmental Disabilities
- ClinicalTrials.gov ID
- NCT06231485
- Acronym / sponsor ID
- STEPS2 / 2022-0617
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 856 participants (estimated)
- Lead sponsor
- City University of New York, School of Public HealthUniversity, hospital or other
- 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
- Study start
- 20 Oct 2023 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 30 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- have had a discussion with a medical professional about their sexual health (including sexually transmitted infection testing for those who are sexually active);
- know whether they have had the HPV vaccination;
- have had the HPV vaccination;
- know what sex is; and
- 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.
Detailed description
The goal of this clinical trial is to test the effectiveness of a 6-week socialization and sex education curriculum (STEPS2) among 856 adolescent and young adults (aged 16-27 years) with mild to moderate intellectual or developmental disabilities (I/DD), including people with Down syndrome.
The investigators are recruiting participants through collaboration with the New York State Office of People with Developmental Disabilities (OPWDD), Service Providers, Care Coordination Organizations and special programs, such as the Special Olympics. For participants who meet eligibility criteria and have consented or assented (as appropriate), a video call meeting is arranged to complete the baseline interview survey of socio-demographic characteristics and sexual and reproductive health knowledge and behaviors. The interview takes up to 45 minutes to complete. Once the baseline interview is completed the participant is randomly assigned to either the STEPS2 or the STYH arm of the study. Half of the participants will be randomized to STEPS2, and half to the STYH arm. Participants begin the intervention within 2 weeks of having completed the baseline survey.
For the intervention, participants in both arms receive virtual video call one hour weekly health education sessions for 6 weeks. The STEPS2 socialization and sexuality curriculum (experimental arm) is provided during one-on-one sessions between a Study Health Educator and the participant. The STYH curriculum (comparison arm) is provided during group sessions with 6-10 participants and a Study Health Educator. For both arms, participants choose whether they wish for a guardian or helper to also attend for a given session.
Participants have follow-up interview surveys at month 2 (after completing the health education intervention), month 6, and month 12, with the same sexual and reproductive health measures as included in the baseline survey. The month 2 interviews also include measures of participant satisfaction with the curriculum and with the Study Health Educator. Each survey takes up to 45 minutes to complete. Survey interviewers are blinded to which curriculum participants have received.
The investigators are comparing the proportion of participants who have had a conversation with a doctor about sex, know their HPV vaccination status, have had the HPV vaccine, and show an understanding of sex and pregnancy at the month 12 interview between the two arms, after adjusting for baseline measures of these indicators, to test whether participation in the STEPS2 arm had an effect on these measures. Analysis will include intention-to-treat estimates, as well as instrumental variable estimates to adjust for incomplete attendance to the 6-week curricula. Analyses will also be stratified by gender, age, and mild versus moderate I/DD.
If the STEPS2 curriculum is found to improve reproductive and sexual health knowledge and behaviors, the investigators will email the curriculum to all participants in the STYH arm at study completion. Both curricula will be made publicly available at the end of the study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Half of the participants will be randomized to receive the socialization and sex education curriculum (STEPS2), and half to the nutrition and physical exercise curriculum (STYH)
| Arm | Type | Receives |
|---|---|---|
| Socialization and sex education (STEPS2) | Experimental | Behavioral: STEPS2Weekly 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. |
| Nutrition and physical activity (STYH) | Other | Behavioral: STYHThe 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. |
Who may qualify
- Ages
- 16 to 27 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- if female sex, self-reports pregnant at screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STEPS2One of the two health education curricula as described in arm/group descriptions. | Behavioural | Socialization and sex education (STEPS2) |
| STYHOne of the two health education curricula as described in arm/group descriptions. | Behavioural | Nutrition and physical activity (STYH) |
Primary outcome
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
7 secondary outcomes
Average sexual health knowledge score (1-25, with 25 being high knowledge)
Time frame: One year post enrollment
Average sexual health knowledge score (1-25, with 25 being high knowledge)
Time frame: 6 months post enrollment
Average sexual health knowledge score (1-25, with 25 being high knowledge)
Time frame: Two months post enrollment (after completion of 6 week intervention)
Proportion using birth control among those reporting vaginal sex
Time frame: One year post enrollment
Proportion using condoms among those reporting vaginal and/or anal sex
Time frame: One year post enrollment
Proportion tested for STDs among those reporting vaginal and/or anal sex
Time frame: One year post enrollment
Average satisfaction with intervention score (1 to 5, with 5 being very satisfied)
Time frame: Two months post enrollment (after completion of 6 week intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: Yes. Anonymized survey data from baseline, month 2, 6 and 12 will be made available for other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Suzanne McDermott, PhD contact
Suzanne McDermott, PhD principal investigator
CUNY School of Public Health
Heidi E Jones, PhD principal investigator
CUNY School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STEPS2 and STYH in people with Knowledge and Behavior, run by City University of New York, School of Public Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heidi E Jones, PhD (646-364-9529, heidi.jones@sph.cuny.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion who have had a sexual health discussion with medical professional (time frame: One year post enrollment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.