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

NCT06231485 | Recruiting DMC

• 2 other identifiers: 2022-06171R01HD111044-01
• Study Type: interventional
• Target: 856
• Locations: 1 country
• Sites: 1

Brief 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. The main question it aims to answer is: Does the STEPS2 health education curriculum increase the proportion of individuals who:

1. 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. 2.know whether they have had the HPV vaccination;
3. 3.have had the HPV vaccination;
4. 4.know what sex is; and
5. 5.know how people get pregnant.

Conditions

Knowledge; Behavior

Outcome Measures

Primary Outcomes (5)

• Proportion who have had a sexual health discussion with medical professional

  Have had a sexual health discussion with medical professional

  One year post enrollment

• Proportion who know their HPV vaccination status

  Know whether they have been vaccinated for HPV

  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)

  One year post enrollment

• Proportion who can accurately describe what sex is

  Understand what sex is based on response to an open-ended question

  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

  One year post enrollment

Secondary Outcomes (7)

• Average sexual health knowledge score (1-25, with 25 being high knowledge)

  One year post enrollment

• Average sexual health knowledge score (1-25, with 25 being high knowledge)

  6 months post enrollment

• Average sexual health knowledge score (1-25, with 25 being high knowledge)

  Two months post enrollment (after completion of 6 week intervention)

• Proportion using birth control among those reporting vaginal sex

  One year post enrollment

• Proportion using condoms among those reporting vaginal and/or anal sex

  One year post enrollment

Study Arms (2)

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.

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.

Behavioral: STYH

Interventions

STEPS2 BEHAVIORAL

One of the two health education curricula as described in arm/group descriptions.

Socialization and sex education (STEPS2)

STYH BEHAVIORAL

One of the two health education curricula as described in arm/group descriptions.

Nutrition and physical activity (STYH)

Eligibility Criteria

• Age: 16 Years - 27 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• if female sex, self-reports pregnant at screening

Sponsors & Collaborators

• City University of New York, School of Public Health: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• National Institutes of Health INCLUDE Project: collaborator
• National Institutes of Health Office of Disease Prevention: collaborator

Study Sites (1)

CUNY School of Public Health (but interventions are virtual)

New York, New York, 10027, United States

RECRUITING

MeSH Terms

Conditions

Behavior

Study Officials

• Suzanne McDermott, PhD

  CUNY School of Public Health

  PRINCIPAL INVESTIGATOR

• Heidi E Jones, PhD

  CUNY School of Public Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heidi E Jones, PhD

CONTACT

646-364-9529; heidi.jones@sph.cuny.edu

Suzanne McDermott, PhD

CONTACT

suzanne.mcdermott@sph.cuny.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Interviewers (outcomes assessors) are masked to the intervention arm to reduce the potential for bias during the interview process, as all surveys are interviewer-administered.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: September 20, 2023
• First Posted: January 30, 2024
• Study Start: October 20, 2023
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Anonymized data will be made available within 6 months of publication on primary endpoints, with no end date for this availability.
• Access Criteria: We will make the data available on the NIH's Project INCLUDE data hub.

Locations

US (1)