[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100533873":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":36,"locations":43,"responsibleParty":64,"collaborators":66,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":22,"eligibilityCriteria":81,"healthyVolunteers":82,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":25,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":25,"overallStatus":46,"whyStopped":25,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"City University of New York, School of Public Health","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Behavioral: STEPS2",{"label":15,"type":6,"description":16,"interventionNames":17},"Nutrition and physical activity (STYH)","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.\n\nWeekly 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.",[18],"Behavioral: STYH",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","STEPS2","One of the two health education curricula as described in arm\u002Fgroup descriptions.",[9],null,{"type":21,"name":27,"description":23,"armGroupLabels":28,"otherNames":25},"STYH",[15],[30,34],{"name":31,"affiliation":32,"role":33},"Suzanne McDermott, PhD","CUNY School of Public Health","PRINCIPAL_INVESTIGATOR",{"name":35,"affiliation":32,"role":33},"Heidi E Jones, PhD",[37,41],{"name":35,"role":38,"phone":39,"phoneExt":25,"email":40},"CONTACT","646-364-9529","heidi.jones@sph.cuny.edu",{"name":31,"role":38,"phone":25,"phoneExt":25,"email":42},"suzanne.mcdermott@sph.cuny.edu",[44],{"facility":45,"status":46,"city":47,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"CUNY School of Public Health (but interventions are virtual)","RECRUITING","New York","10027","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-74.00597,40.71427,{"lat":55,"lon":54},[58,61],{"name":59,"role":38,"phone":25,"phoneExt":25,"email":60},"Louie Cao","louie.cao@sph.cuny.edu",{"name":62,"role":38,"phone":25,"phoneExt":25,"email":63},"Vanessa Colon","vanessa.colon@sph.cuny.edu",{"type":65,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[67,70,73],{"name":68,"class":69},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","NIH",{"name":71,"class":72},"National Institutes of Health INCLUDE Project","UNKNOWN",{"name":74,"class":72},"National Institutes of Health Office of Disease Prevention","100533873","socialization-to-enrich-participation--support-sexuality-for-young-people-with-idd-100533873",false,"NCT06231485","Socialization To Enrich Participation & Support Sexuality for Young People With I\u002FDD","A Randomized Intervention Trial to Increase Access to Reproductive Health Services Among Adolescents and Young Adults With Intellectual and Developmental Disabilities","Inclusion Criteria:\n\n* 16-27 years of age\n* resides in New York State\n* mild\u002Fmoderate I\u002FDD\n* willing to receive either STEPS2 or STYH curricula\n* able to complete curriculum in English\n\nExclusion Criteria:\n\n* if female sex, self-reports pregnant at screening",true,"ALL","16 Years","27 Years",{"count":87,"type":88},856,"ESTIMATED","INTERVENTIONAL",[91],"NA","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\u002FDD), including people with Down syndrome.\n\nThe main question it aims to answer is:\n\nDoes the STEPS2 health education curriculum increase the proportion of individuals who:\n\n1. have had a discussion with a medical professional about their sexual health (including sexually transmitted infection testing for those who are sexually active);\n2. know whether they have had the HPV vaccination;\n3. have had the HPV vaccination;\n4. know what sex is; and\n5. know how people get pregnant.\n\nThese 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.\n\nParticipants 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).\n\nParticipants 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.\n\nResearchers 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.",[94,95],"Knowledge","Behavior","2024-01-29",{"date":98,"type":99},"2024-01-30","ACTUAL",{"date":101,"type":99},"2023-10-20",{"date":103,"type":88},"2027-02",{"name":5,"class":6},1]