Ignite Creation Date:
2024-05-06 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06231485
Status:
RECRUITING
Last Update Posted:
2024-01-30
First Post:
2023-09-20
Brief Title:
Socialization To Enrich Participation Support Sexuality for Young People With IDD
Sponsor:
City University of New York School of Public Health
Organization:
City University of New York School of Public Health
Study Overview
Official Title:
A Randomized Intervention Trial to Increase Access to Reproductive Health Services Among Adolescents and Young Adults With Intellectual and Developmental Disabilities
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STEPS2
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 IDD 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
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
Detailed 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 IDD 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 IDD
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
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 IDD
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01HD111044-01 | NIH | None | httpsreporternihgovquickSearch1R01HD111044-01 |