Actively Recruiting
A Randomized Intervention Trial to Increase Access to Reproductive Health Services Among Adolescents and Young Adults With Intellectual and Developmental Disabilities
Led by City University of New York, School of Public Health · Updated on 2024-01-30
856
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
C
City University of New York, School of Public Health
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to test how well a 6-week socialization and sex education program called STEPS2 works for young people aged 16 to 27 years with mild to moderate intellectual and developmental disabilities (I/DD), including those with Down syndrome. The study focuses on whether STEPS2 can improve knowledge and behaviors related to sexual health, such as discussions with medical professionals, HPV vaccination status, and understanding of sex and pregnancy. The trial compares STEPS2 with a different health education program focusing on nutrition and exercise. Participants are randomly assigned to one of two groups. The STEPS2 group receives weekly one-hour, one-on-one virtual sessions with a health educator covering topics like the human body, decision-making, sexually transmitted diseases, pregnancy, birth control, parenting, and visiting the doctor. The comparison group, called Steps To Your Health (STYH), meets weekly in small virtual groups to learn about nutrition, exercise, stress management, and healthy behaviors. Both programs last six weeks and participants can choose to have a guardian or helper join sessions. Participants complete surveys before starting, at 2 months, 6 months, and 12 months after enrollment to assess their knowledge, behaviors, and satisfaction with the program. Researchers measure outcomes such as conversations with doctors about sexual health, HPV vaccination knowledge and status, and understanding of sex and pregnancy one year after enrollment. They also track contraception and STI prevention behaviors among sexually active participants. The study includes safety monitoring and plans to share the STEPS2 curriculum with all participants after the study if it proves effective.
CONDITIONS
Brief Title
Socialization To Enrich Participation & Support Sexuality for Young People With I/DD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 16 to 27 years
- Reside in New York State
- Have mild to moderate intellectual or developmental disability
- Willing to receive either the STEPS2 or STYH curriculum
- Able to complete the curriculum in English
You will not qualify if you...
- If female, currently pregnant at screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 day
Participants complete a baseline interview survey to collect socio-demographic information and sexual and reproductive health knowledge and behaviors.
1 virtual video call visit
Duration - 6 weeks
Participants receive weekly virtual health education sessions for 6 weeks, either one-on-one sessions with a Study Health Educator (STEPS2 curriculum) or group sessions with 6-10 participants (STYH curriculum).
1 virtual video call per week for 6 weeks
Duration - 12 months
Participants complete follow-up interview surveys at 2, 6, and 12 months after the intervention to assess sexual and reproductive health measures and satisfaction with the curriculum.
1 virtual video call visit at 2 months, 1 at 6 months, and 1 at 12 months
Trial Site Locations
Total: 1 location
1
CUNY School of Public Health (but interventions are virtual)
New York, New York, United States, 10027
Actively Recruiting
Research Team
H
Heidi E Jones, PhD
S
Suzanne McDermott, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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