Actively Recruiting

Phase Not Applicable
Age: 16Years - 27Years
All Genders
Healthy Volunteers
ID06231485

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

Age: 16Years - 27Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

You will not qualify if you...

  • If female, currently pregnant at screening

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Baseline Interview

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

Intervention

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

Follow-up Interviews

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

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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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