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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment STEPS2, Socialization To Enrich Participation & Support Sexuality, for sexual health education in young people with intellectual and developmental disabilities?

The research highlights the importance of innovative interventions and education programs for improving sexual health outcomes in youth with disabilities. Programs like the Disability-inclusive Sexual Health Network (DSHN) and Girls' Talk+ have shown progress in addressing sexual health needs and barriers, suggesting that similar approaches, like STEPS2, could be effective in supporting sexual health education for young people with intellectual and developmental disabilities. ^{1 2 3 4 5}

How is the STEPS2 treatment different from other treatments for sexual health education in young people with intellectual and developmental disabilities?

STEPS2 is unique because it focuses on providing comprehensive sexual health education specifically tailored for young people with intellectual and developmental disabilities, using an inclusive educational framework that incorporates multiple media types and clear, concise language to ensure accessibility and understanding. ^{5 6 7 8 9}

Research Team

Suzanne McDermott, PhD

Principal Investigator

CUNY School of Public Health

Heidi E Jones, PhD

Principal Investigator

CUNY School of Public Health

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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 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]

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]

References

1. United States 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). [2023]

2. Israel pubmed.ncbi.nlm.nih.gov

Social-sexual education in adolescents with behavioral neurogenetic syndromes. [2010]

3. Switzerland 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. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Young Voices: Sexual Health and Transition Care Needs in Adolescents with Intersex/Differences of Sex Development-A Pilot Study. [2021]

5. England pubmed.ncbi.nlm.nih.gov

A mixed methods evaluation of Girls' Talk+: A sexuality education programme for girls with mild intellectual disabilities. [2022]

6. England 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. [2020]

7. England pubmed.ncbi.nlm.nih.gov

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

8. England pubmed.ncbi.nlm.nih.gov

Sexuality in children and adolescents with disabilities. [2009]

9. United States pubmed.ncbi.nlm.nih.gov

Sexuality and Disability in Adolescents. [2018]