Sexual Health Education for Young People With I/DD

(STEPS2 Trial)

Overseen By Suzanne McDermott, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

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

Disqualifiers: Pregnancy

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

Duration: 6 weeks

856 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a 6-week sex education program, called STEPS2, to determine if it improves sexual health knowledge and behaviors in young people with intellectual and developmental disabilities (I/DD), including those with Down syndrome. Participants will either join the STEPS2 program, which focuses on sexual health, or a comparison group that learns about nutrition and exercise. The trial aims to assess whether STEPS2 helps participants discuss sexual health with doctors, understand HPV vaccination, and learn about pregnancy and contraception. The trial seeks individuals aged 16-27 with mild to moderate I/DD living in New York State who can participate in English. As an unphased trial, this study offers a unique opportunity to contribute to important research that could enhance sexual health education for young people with I/DD.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the STEPS2 curriculum is safe for young people with I/DD?

Previous studies have shown that the STEPS2 program helps young people with intellectual and developmental disabilities (I/DD) learn about sexual health. The program includes weekly online sessions with a health educator, covering topics such as the human body, decision-making, sexually transmitted diseases (STDs), pregnancy, birth control, and visiting the doctor.

Specific safety data for the STEPS2 program is unavailable because it is an educational course, not a medication or medical procedure. However, similar educational programs are generally safe and well-received. Participants typically learn in a supportive environment, which helps them feel comfortable and safe during the sessions. No known risks are associated with participating in this type of educational program. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional approaches that focus primarily on nutrition and exercise for young people with intellectual and developmental disabilities (I/DD), the STEPS2 treatment offers a tailored curriculum addressing socialization and sexual health education. It provides personalized, one-on-one virtual sessions covering crucial topics like the human body, decision-making, sexually transmitted diseases, and reproductive health. Researchers are excited about STEPS2 because it uniquely targets comprehensive sexual health education, aiming to empower young people with I/DD with knowledge and skills essential for making informed choices about their sexual and reproductive health.

What evidence suggests that the STEPS2 curriculum is effective for improving sexual health education in young people with I/DD?

Studies have shown that comprehensive sex education programs effectively increase knowledge about sexual health and encourage healthy behaviors. Research indicates that these programs help people understand important topics like sexually transmitted infections, pregnancy, and birth control. In this trial, participants in the "Socialization and Sex Education" arm will receive the STEPS2 curriculum. Early results suggest this curriculum might improve participants' understanding of sexual and reproductive health, including learning about the HPV vaccine and discussing sexual health with healthcare professionals. Overall, these programs aim to empower individuals by providing the information needed to make informed health decisions. ^{1 3 6 7 8}

Who Is on the Research Team?

Suzanne McDermott, PhD

Principal Investigator

CUNY School of Public Health

Heidi E Jones, PhD

Principal Investigator

CUNY School of Public Health

Are You a Good Fit for This Trial?

This trial is for young people aged 16-27 with intellectual and developmental disabilities, including those with Down syndrome. They should be interested in learning about sexual health or improving physical health through nutrition and exercise.

Inclusion Criteria

Able to complete curriculum in English

I am between 16 and 27 years old.

Resides in New York State

Exclusion Criteria

I am pregnant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Interview

Participants complete a baseline interview survey of socio-demographic characteristics and sexual and reproductive health knowledge and behaviors

1 week

1 visit (virtual)

Treatment

Participants receive either the STEPS2 socialization and sex education curriculum or the STYH nutrition and physical exercise curriculum for 6 weeks

6 weeks

6 visits (virtual, weekly)

Follow-up

Participants are monitored for sexual and reproductive health knowledge and behaviors at months 2, 6, and 12 post-enrollment

12 months

3 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• STEPS2
• STYH

Trial Overview The STEPS2 curriculum aims to improve sexual health knowledge and behaviors in participants by offering one-on-one education sessions. It's being compared to a group-based program focused on nutrition and exercise called STYH.

How Is the Trial Designed?

Group I: Socialization and sex education (STEPS2) Experimental Treatment 1 Intervention

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.

Group II: Nutrition and physical activity (STYH) Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

City University of New York, School of Public Health

Lead Sponsor

Trials

27

Recruited

36,200+

National Institutes of Health INCLUDE Project

Collaborator

Trials

1

Recruited

860+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

National Institutes of Health Office of Disease Prevention

Collaborator

Trials

1

Recruited

860+

Published Research Related to This Trial

The Disability-inclusive Sexual Health Network (DSHN) aims to improve sexual health outcomes for youth with disabilities in Virginia by developing and evaluating innovative interventions, addressing barriers to health, teen pregnancy, and STIs.

In its first year, DSHN collected 67 submissions using the Monthly Reporting Instrument (MRI), which helped identify common challenges and successes, and will guide improvements in support and coordination activities for the second year.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a Tool for Monitoring and Evaluating a Network Approach to Innovation: Lessons from Year 1 of the SexEdVA Disability-Inclusive Sexual Health Network (DSHN). Hartzler-Weakley, K., Duer, E., McKean, K.[2023]

Adolescents with mild to moderate disabilities have sexual activity and reproductive health needs similar to their peers without disabilities, highlighting the importance of addressing sexuality in this population.

Medical providers play a crucial role in supporting healthy sexual development by offering education, guidance, and management of menstrual and contraceptive needs, which may be even more critical for adolescents with disabilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sexuality and Disability in Adolescents. Holland-Hall, C., Quint, EH.[2018]

A workshop involving 33 participants from 8 EU countries successfully facilitated shared learning among individuals with disorders of sexual development (DSD), their parents, healthcare providers, and support groups, highlighting the importance of collaboration in healthcare delivery.

Key insights from the workshop emphasized the need for knowledgeable healthcare providers, the significance of support groups, and the necessity for comprehensive discussions on diagnosis, childhood care, and transition to adult care for individuals with DSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Involving Individuals with Disorders of Sex Development and Their Parents in Exploring New Models of Shared Learning: Proceedings from a DSDnet COST Action Workshop. Sanders, C., Hall, J., Sanders, C., et al.[2022]

Adolescents and young adults with intellectual and developmental disabilities are just as likely to be sexually active as their peers, yet they often lack access to comprehensive sexual education, highlighting a significant gap in health care.

To improve sexual education for these individuals, educators should adopt a non-judgmental and inclusive approach, utilizing universal design for learning principles to create accessible and engaging educational materials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sexual health education for adolescents and young adults with intellectual and developmental disabilities: recommendations for accessible sexual and reproductive health information. Roden, RC., Schmidt, EK., Holland-Hall, C.[2020]

Adolescents with disabilities often engage in sexual relationships but lack the necessary knowledge and skills for healthy and safe sexual experiences, highlighting a significant gap in sexual education.

There are societal barriers and functional limitations that hinder sexual development in these individuals, yet opportunities exist for them to achieve sexual expression and fulfillment, emphasizing the need for healthcare providers to address these unmet needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sexuality in children and adolescents with disabilities. Murphy, N.[2009]

Young people with special needs have the same rights as others to receive comprehensive sexual health education, but current provisions in schools are inadequate despite national guidance.

To empower these young individuals, comprehensive education programs are essential, along with societal changes to improve attitudes towards their sexuality and relationships.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving sexual health education for young people with learning disabilities. Doyle, J.[2019]

Adolescents with intersex/Differences of Sex Development (DSD) express a strong need for open-minded healthcare providers who understand their unique sexual health needs and experiences, highlighting the importance of tailored communication in their care.

The study reveals that these youths desire more involvement in their sexual health discussions and information as they transition to adulthood, indicating a gap in current transitional care that needs to be addressed for better support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Young Voices: Sexual Health and Transition Care Needs in Adolescents with Intersex/Differences of Sex Development-A Pilot Study. Callens, N., Kreukels, BPC., van de Grift, TC.[2021]

The Girls' Talk+ sexuality education program significantly improved knowledge, attitudes, and self-efficacy regarding sexual health among girls with mild intellectual disabilities, based on a study involving 249 participants.

Both trainers and participants reported high satisfaction with the program, indicating its effectiveness and acceptance in addressing the sexual health education needs of this group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A mixed methods evaluation of Girls' Talk+: A sexuality education programme for girls with mild intellectual disabilities. van den Toren, SJ., de Haas, S., Dalmijn, E., et al.[2022]

A Social Sexual Group Education Program was conducted with 10 adolescents with neurogenetic syndromes and their 14 parents, focusing on self-identification, acceptance of disabilities, and developing social and sexual knowledge over 10 biweekly sessions.

The program highlighted the importance of early and ongoing sexual and social education for adolescents with developmental disabilities, suggesting that such interventions should begin before adolescence and continue into young adulthood to effectively address their needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Social-sexual education in adolescents with behavioral neurogenetic syndromes. Plaks, M., Argaman, R., Stawski, M., et al.[2010]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06231485

Study Details | NCT06231485 | Socialization To Enrich ... The goal of this clinical trial is to test the effectiveness of a 6-week socialization and sex education curriculum (STEPS2) in young people ...

2. cunyisph.org cunyisph.org/projects/steps2/

STEPS2: Socialization To Enrich Participation & Support ... The evaluated outcomes will include proportion of participants demonstrating an increase in social sexual health knowledge, as well as related behaviors ...

3. withpower.com withpower.com/trial/phase-behaviour-9-2023-339d0

Sexual Health Education for Young People With I/DD 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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11683015/

Understanding Comprehensive Sexuality Education This review delves into the definitions and importance of sexuality and CSE, emphasizing CSE's critical need in today's society to promote informed, healthy ...

5. esmed.org esmed.org/MRA/index.php/mra/article/view/6140

Data Supporting a Comprehensive Approach to ... Although research documents a more comprehensive approach to sex education is preferred by the majority and is effective in reducing risky ...

6. cunyisph.org cunyisph.org/steps2-study/

STEPS2 Health Education STEPS2 is a study being done by teachers at the City University of New York (CUNY School of Public Health). The study is funded by the National Institutes of ...

7. starbridgeinc.org starbridgeinc.org/event/steps2-socialization-314/

STEPS2: Socialization To Enrich Participation and Support ... This presentation will provide an overview of the STEPS2 health education intervention and how to get involved.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11890547/

Young people with disabilities and their sexual health The aim of this descriptive review was to describe and analyze articles exploring needs, recommendations and interventions for promoting the sexual health (SH) ...