[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100369566":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":36,"centralContacts":45,"locations":54,"responsibleParty":70,"collaborators":72,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":81,"acronym":27,"eligibilityCriteria":82,"healthyVolunteers":79,"sex":83,"minAge":27,"maxAge":27,"enrollmentInfo":84,"targetDuration":27,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":93,"overallStatus":56,"whyStopped":27,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Brown University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Stepped-care intervention (SCI) group","EXPERIMENTAL","In the SCI group, mothers with low baseline depressive symptoms are offered the problem-solving education (PSE) prevention intervention, and mothers with greater depressive symptoms are offered Engagement Sessions.",[13,14],"Behavioral: Problem-solving education (PSE)","Behavioral: Engagement sessions",{"label":16,"type":17,"description":18,"interventionNames":19},"Usual care control group","ACTIVE_COMPARATOR","Families in the control group will receive usual Head Start services.",[20],"Behavioral: Usual care",[22,28,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"BEHAVIORAL","Problem-solving education (PSE)","PSE will be offered to mothers with low baseline depressive symptoms (the first, preventive step of the SCI). PSE participants will have their symptoms assessed at each session and will convert to Engagement Sessions if they meet pre-specified 'step up' criteria.",[9],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"Engagement sessions","Engagement sessions will be offered to mothers with greater depressive symptoms to link them to formal mental health services (the second, referral step of the SCI)",[9],{"type":23,"name":33,"description":34,"armGroupLabels":35,"otherNames":27},"Usual care","Normal services provided children and their mothers in Head Start",[16],[37,40,42],{"name":38,"affiliation":5,"role":39},"Emily Feinberg, ScD CPNP","PRINCIPAL_INVESTIGATOR",{"name":41,"affiliation":5,"role":39},"Michael Silverstein, MD",{"name":43,"affiliation":44,"role":39},"Amy Yule, MD","Boston Medical Center",[46,50],{"name":43,"role":47,"phone":48,"phoneExt":27,"email":49},"CONTACT","(617) 414-1936","amy.yule@bmc.org",{"name":51,"role":47,"phone":52,"phoneExt":27,"email":53},"Jocelyn Antonio, MPH","401-863-2259","Jocelyn_antonio@brown.edu",[55],{"facility":44,"status":56,"city":57,"state":58,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"RECRUITING","Boston","Massachusetts","02119","United States","US",{"type":63,"coordinates":64},"Point",[65,66],-71.05977,42.35843,{"lat":66,"lon":65},[69],{"name":43,"role":47,"phone":27,"phoneExt":27,"email":27},{"type":71,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR",[73,76],{"name":74,"class":75},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","NIH",{"name":44,"class":6},"100369566","improving-preschool-outcomes-by-addressing-maternal-depression-in-head-start-100369566",false,"NCT04092010","Improving Preschool Outcomes by Addressing Maternal Depression in Head Start","Inclusion Criteria:\n\n* Mother of a 0 to 5-year-old Head Start child\n* Mother speaks English or Spanish\n\nExclusion Criteria:\n\n* Mother with suicidal ideation\n* Mother with cognitive limitation","FEMALE",{"count":85,"type":86},388,"ESTIMATED","INTERVENTIONAL",[89],"NA","Within a research network of Head Start centers in Massachusetts, an efficacy trial of a stepped-care intervention (SCI) to address maternal depression, using intervention components that both prevent depression and help those in major depressive episode (MDE) engage with care, will be conducted. Both the prevention and engagement components of the model have strong, supportive randomized trial evidence for both their efficacy and safety; but they have yet to be synthesized and tested within a coordinated intervention, applicable to a broad population base. Stepped-care interventions are commonly used in mental health service projects, in which the intensity or type of service is calibrated to the severity of illness.",[92],"Maternal Depression",[94,95,96,97,98],"Stepped care intervention","Problem solving education","Engagement session","Head Start","Preschool children","2024-12-06",{"date":101,"type":102},"2024-12-11","ACTUAL",{"date":104,"type":102},"2023-08-16",{"date":106,"type":86},"2028-04-30",{"name":5,"class":6},1]