Socialization To Enrich Participation & Support Sexuality for Young People With I/DD (STEPS2)

City University of New York, School of Public Health

Status: Enrolling

Conditions: Behavior; Knowledge

Treatments: Behavioral: STYH; Behavioral: STEPS2

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06231485

1R01HD111044-01 (U.S. NIH Grant/Contract)

2022-0617

Details and patient eligibility

About

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.

Full description

The goal of this clinical trial is to test the effectiveness of a 6-week socialization and sex education curriculum (STEPS2) among 856 adolescent and young adults (aged 16-27 years) with mild to moderate intellectual or developmental disabilities (I/DD), including people with Down syndrome.

The investigators are recruiting participants through collaboration with the New York State Office of People with Developmental Disabilities (OPWDD), Service Providers, Care Coordination Organizations and special programs, such as the Special Olympics. For participants who meet eligibility criteria and have consented or assented (as appropriate), a video call meeting is arranged to complete the baseline interview survey of socio-demographic characteristics and sexual and reproductive health knowledge and behaviors. The interview takes up to 45 minutes to complete. Once the baseline interview is completed the participant is randomly assigned to either the STEPS2 or the STYH arm of the study. Half of the participants will be randomized to STEPS2, and half to the STYH arm. Participants begin the intervention within 2 weeks of having completed the baseline survey.

For the intervention, participants in both arms receive virtual video call one hour weekly health education sessions for 6 weeks. The STEPS2 socialization and sexuality curriculum (experimental arm) is provided during one-on-one sessions between a Study Health Educator and the participant. The STYH curriculum (comparison arm) is provided during group sessions with 6-10 participants and a Study Health Educator. For both arms, participants choose whether they wish for a guardian or helper to also attend for a given session.

Participants have follow-up interview surveys at month 2 (after completing the health education intervention), month 6, and month 12, with the same sexual and reproductive health measures as included in the baseline survey. The month 2 interviews also include measures of participant satisfaction with the curriculum and with the Study Health Educator. Each survey takes up to 45 minutes to complete. Survey interviewers are blinded to which curriculum participants have received.

The investigators are comparing the proportion of participants who have had a conversation with a doctor about sex, know their HPV vaccination status, have had the HPV vaccine, and show an understanding of sex and pregnancy at the month 12 interview between the two arms, after adjusting for baseline measures of these indicators, to test whether participation in the STEPS2 arm had an effect on these measures. Analysis will include intention-to-treat estimates, as well as instrumental variable estimates to adjust for incomplete attendance to the 6-week curricula. Analyses will also be stratified by gender, age, and mild versus moderate I/DD.

If the STEPS2 curriculum is found to improve reproductive and sexual health knowledge and behaviors, the investigators will email the curriculum to all participants in the STYH arm at study completion. Both curricula will be made publicly available at the end of the study.

Enrollment: 856 estimated patients

Sex: All

Ages: 16 to 27 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 16-27 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

Exclusion criteria

• if female sex, self-reports pregnant at screening

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

856 participants in 2 patient groups

Socialization and sex education (STEPS2)

Experimental group

Description:

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.

Treatment:

Behavioral: STEPS2

Nutrition and physical activity (STYH)

Other group

Description:

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.

Treatment:

Behavioral: STYH