[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100486483":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":39,"responsibleParty":76,"collaborators":79,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":89,"sex":90,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":24,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":102,"overallStatus":42,"whyStopped":24,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"Stony Brook University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Mom Power","EXPERIMENTAL","Mom Power is an evidence-based 13-session psychosocial mother-child group intervention that improves sensitive caregiving, parental stress, and depression",[13],"Behavioral: Mom Power",{"label":15,"type":16,"description":17,"interventionNames":18},"Control","SHAM_COMPARATOR","Controls participants for the intervention receive 10 weekly mailings, with content relevant for the postpartum period (i.e., information on baby sleep, developmental milestones, box breathing and other self-care\u002Fcoping strategies, fun games to play with a baby, and community resources, and general parenting); plus 10 brief check-in phone calls verifying that material was received, and additional longer phone calls to assess any imminent family needs and provide resources as needed\u002Frequested.",[13],[20],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"BEHAVIORAL","Experimental participants will receive virtual Mom Power via phone\u002Finternet connection. Control participants will receive mail information and confirmation phone calls.",[15,9],null,[26],{"name":27,"affiliation":5,"role":28},"James E Swain, MD, PhD","PRINCIPAL_INVESTIGATOR",[30,35],{"name":31,"role":32,"phone":33,"phoneExt":24,"email":34},"Elle Eggers, BSc","CONTACT","636-667-0135","elle.eggers@stonybrookmedicine.edu",{"name":36,"role":32,"phone":37,"phoneExt":24,"email":38},"Diana Saum, MA, MSW","3016334402","dcsaum@med.umich.edu",[40,62],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"University of Michigan","RECRUITING","Ann Arbor","Michigan","48109","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-83.74088,42.27756,{"lat":52,"lon":51},[55,59],{"name":56,"role":32,"phone":57,"phoneExt":24,"email":58},"Maria Muzik, MD, MSc","734-846-8027","muzik@med.umich.edu",{"name":60,"role":32,"phone":61,"phoneExt":24,"email":38},"Diana Saum, MSW","301-633-4402",{"facility":5,"status":42,"city":63,"state":64,"zip":65,"country":46,"countryCode":47,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"Stony Brook","New York","11794",{"type":49,"coordinates":67},[68,69],-73.14094,40.92565,{"lat":69,"lon":68},[72,75],{"name":27,"role":32,"phone":73,"phoneExt":24,"email":74},"516-838-7604","james.swain@stonybrookmedicine.edu",{"name":31,"role":32,"phone":33,"phoneExt":24,"email":34},{"type":28,"investigatorFullName":77,"investigatorTitle":78,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"James Edward Swain","Associate Professor",[80],{"name":41,"class":6},"100486483","postpartum-intervention-for-mothers-with-opioid-use-disorders-100486483",false,"NCT05614661","Postpartum Intervention for Mothers With Opioid Use Disorders","Postpartum Intervention for Mothers With Opioid Use Disorders - Brain-Behavior Mechanisms","PIMO","Inclusion Criteria:\n\n* mothers aged 18-50 from SBU or UM with diagnosis of Opioid Use Disorder (OUD); and\u002For receiving medication assisted treatment (such as buprenorphine or methadone)\n* with a child aged 5 or less\n* able to read, hear and understand English adequately enough to provide informed consent\n\nExclusion Criteria:\n\n1. require immediate clinical care for suicidal\u002Fhomicidal risk or psychosis (please see Protection of Human Subjects section for clinical management of suicidal risk);\n2. For magnetic resonance imaging (MRI) of the brain, potential participants will be excluded if they:\n\n1\\) have ferromagnetic metal in their heads 2) have severe claustrophobia that prevents participation in the neuroimaging 3) have serious neurological condition that could interfere with neuroimaging, including a brain tumor, multiple sclerosis or significant head trauma 4) Exclusion from MRI does not necessarily exclude participant from study.",true,"FEMALE","18 Years","50 Years",{"count":94,"type":95},50,"ESTIMATED","INTERVENTIONAL",[98],"NA","Opioid use disorder (OUD) is a fast-growing and devastating epidemic in the US with many mothers suffering cravings, depression, impaired interpersonal interactions and maladaptive parenting behaviors that may lead to child maltreatment and costly utilization of foster care. This interdisciplinary multisite project will begin with the high risk R61 phase, in which the investigators will administer the parenting intervention \"Mom Power\" to mothers with OUD during the first 6 months postpartum and look for effects on drug use, mood and brain mechanisms; and, If validated, the investigators will continue in the R33 with more brain mechanism investigation and outcome studies a larger sample. The completion of this grant will clarify the effects of parenting intervention for mothers with OUD, and yield brain-based biomarkers that may be connected with inexpensive measures toward improved treatment of families suffering OUD, their children and society - which ultimately bears much of the cost for the common trans-generational problems of peripartum drug use.",[101],"Opioid Use Disorder",[103,101,104,105,106],"parenting intervention","parental stress","maternal brain","evoked response potentials","2024-12-10",{"date":109,"type":110},"2024-12-16","ACTUAL",{"date":112,"type":110},"2023-02-14",{"date":114,"type":95},"2025-05-01",{"name":5,"class":6},2]