RECRUITING

Socialization To Enrich Participation & Support Sexuality for Young People With I/DD

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

A Randomized Intervention Trial to Increase Access to Reproductive Health Services Among Adolescents and Young Adults With Intellectual and Developmental Disabilities

Quick Facts

Study Start:2023-10-20
Study Completion:2027-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06231485

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:16 Years to 27 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * 16-27 years of age
  2. * resides in New York State
  3. * mild/moderate I/DD
  4. * willing to receive either STEPS2 or STYH curricula
  5. * able to complete curriculum in English
  1. * if female sex, self-reports pregnant at screening

Contacts and Locations

Study Contact

Heidi E Jones, PhD
CONTACT
646-364-9529
heidi.jones@sph.cuny.edu
Suzanne McDermott, PhD
CONTACT
suzanne.mcdermott@sph.cuny.edu

Principal Investigator

Suzanne McDermott, PhD
PRINCIPAL_INVESTIGATOR
CUNY School of Public Health
Heidi E Jones, PhD
PRINCIPAL_INVESTIGATOR
CUNY School of Public Health

Study Locations (Sites)

CUNY School of Public Health (but interventions are virtual)
New York, New York, 10027
United States

Collaborators and Investigators

Sponsor: City University of New York, School of Public Health

  • Suzanne McDermott, PhD, PRINCIPAL_INVESTIGATOR, CUNY School of Public Health
  • Heidi E Jones, PhD, PRINCIPAL_INVESTIGATOR, CUNY School of Public Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-20
Study Completion Date2027-02

Study Record Updates

Study Start Date2023-10-20
Study Completion Date2027-02

Terms related to this study

Additional Relevant MeSH Terms

  • Knowledge
  • Behavior