[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609667":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":24,"locations":30,"responsibleParty":50,"collaborators":52,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":9,"eligibilityCriteria":62,"healthyVolunteers":63,"sex":64,"minAge":18,"maxAge":18,"enrollmentInfo":65,"targetDuration":18,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":75,"overallStatus":32,"whyStopped":18,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Beth Israel Deaconess Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Doula Link","EXPERIMENTAL","Doulas randomized to this arm will receive: 1) a doula-specific mental health toolkit; 2) training to implement an evidence-based, stress-reduction program called Our Babies and Us; 3) training for, and access to expert consultations with perinatal psychiatric specialists through MCPAP for Moms; 4) training on perinatal mental health; 5) access to doula support groups",[13],"Behavioral: Doula Link",{"label":15,"type":16,"description":17,"interventionNames":18},"Doula Support as Usual","NO_INTERVENTION","Doulas randomized to this arm will continue to provide care as usual",null,[20],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":18},"BEHAVIORAL","1\\) a doula-specific mental health toolkit; 2) training to implement an evidence-based, stress-reduction program called Our Babies and Us; 3) training for, and access to expert consultations with perinatal psychiatric specialists through MCPAP for Moms; 4) training on perinatal mental health; 5) access to doula support groups",[9],[25],{"name":26,"role":27,"phone":28,"phoneExt":18,"email":29},"Elysia Larson","CONTACT","617-667-4051","elarson@bidmc.harvard.edu",[31],{"facility":5,"status":32,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"RECRUITING","Boston","Massachusetts","02215","United States","US",{"type":39,"coordinates":40},"Point",[41,42],-71.05977,42.35843,{"lat":42,"lon":41},[45,47],{"name":26,"role":27,"phone":46,"phoneExt":18,"email":29},"6173655776",{"name":48,"role":49,"phone":18,"phoneExt":18,"email":18},"Elysia Larson, ScD, MPH","PRINCIPAL_INVESTIGATOR",{"type":49,"investigatorFullName":26,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Principal Investigator",[53],{"name":54,"class":55},"National Institute of Mental Health (NIMH)","NIH","100609667","testing-doula-link-a-multi-component-intervention-to-improve-perinatal-mental-health-100609667",false,"NCT07217561","Testing \"Doula Link\", a Multi-Component Intervention to Improve Perinatal Mental Health","Doula Link for Perinatal Mental Health - Trial","Inclusion Criteria:\n\n* For doulas: currently providing prenatal or postpartum support to at least one client; plant to provide prenatal or postpartum support to at least three clients in the next six months; work in Massachusetts; did not participate in development of the intervention; available to participate in in-person training; English language fluency\n* For clients: Pregnant or no more than 12 weeks postpartum at enrollment; served by one of the 30 study doulas; live in, and plan to give birth in Massachusetts; fluency in either English or Spanish\n\nExclusion Criteria:\n\n* Not meeting inclusion criteria",true,"ALL",{"count":66,"type":67},90,"ESTIMATED","INTERVENTIONAL",[70],"NA","Doulas are trained individuals who offer informational, emotional, and physical support to their pregnant, birthing, and postpartum clients. The goal of this clinical trial is to learn if a new intervention (called \"Doula Link\") is feasible to implement and acceptable to both doulas and their clients. The main questions it aims to answer are:\n\n* Is Doula Link feasible to implement and acceptable to doulas and their clients?\n* What are the preliminary differences in depression and anxiety between individuals working with doulas who received Doula Link compared to those who did not receive Doula Link?\n\nResearchers will compare \"Doula Link\" to usual doula practice to see if Doula Link is feasible and has potential to improve mental health outcomes in postpartum individuals.\n\nDoulas will be randomly assigned to either receive \"Doula Link\" or continue with their practice as usual.\n\nParticipating doulas assigned to Doula Link will receive training mental health and implementing an intervention called \"Our Babies and Us\"; receive access to a toolkit; receive access to perinatal psychiatrists and referral specialists for consultations; receive access to a support group\n\nAll participating doulas will be invited to complete surveys about their experience with Doula Link (if assigned to that group) and their experience providing care for their clients.\n\nAll participating clients (pregnant and postpartum individuals) will be invited to complete surveys about their experiences with their doulas, their own mental health, and their experiences with the health system.",[73,74],"Perinatal Depression","Perinatal Anxiety",[76,77,78],"Doulas","Perinatal mental health","Depression","2025-10-21",{"date":81,"type":82},"2025-10-22","ACTUAL",{"date":79,"type":82},{"date":85,"type":67},"2027-06",{"name":5,"class":6},1]