[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100355322":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":36,"locations":43,"responsibleParty":62,"collaborators":65,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":75,"sex":76,"minAge":12,"maxAge":12,"enrollmentInfo":77,"targetDuration":12,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":89,"overallStatus":46,"whyStopped":12,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"University of Texas Southwestern Medical Center","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Control Arm","NO_INTERVENTION","Standard of care information given by NICU staff and Follow up Clinic staff, including information about health care, diagnosis, medications, daily cares, anticipatory guidance, and discharge prep information.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Intervention CBT Arm","EXPERIMENTAL","In addition to Standard of care information that the control arm receives, this arm will also receive 5 CBT sessions focusing on past NICU trauma, emotional coping, parental perceptions of child vulnerability, and helpful parenting and emotional coping skills.",[18],"Behavioral: Cognitive Behavioral Therapy",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":12},"BEHAVIORAL","Cognitive Behavioral Therapy","The intervention group will receive standard NICU and follow up care information plus a total of 5 CBT sessions split between the NICU and outpatient clinic visits post discharge from NICU. The CBT sessions will address PPCV in parents and parenting skills to address this. The CBT sessions will be standardized with a manual for study investigators to follow during sessions, and made with Dr. Richard Shaw from Stanford University, who wrote the prior CBT manual for anxiety, depression, and PTSD for NICU parents. Study staff will be trained to give the standardized CBT sessions using the manual via pilot sessions. There will be 3 CBT sessions given in the Parkland NICU before discharge and then 2 in the THRIVE follow up clinic at Children's Medical Center after discharge from the NICU.",[14],[26,30,33],{"name":27,"affiliation":28,"role":29},"Margaret K Hoge, MD","UT Southwestern Medical Center Dallas","PRINCIPAL_INVESTIGATOR",{"name":31,"affiliation":28,"role":32},"Roy Heyne, MD","STUDY_DIRECTOR",{"name":34,"affiliation":35,"role":32},"Richard J Shaw, MD","Stanford University",[37,41],{"name":27,"role":38,"phone":39,"phoneExt":12,"email":40},"CONTACT","214-617-8439","margaret.hoge@utsouthwestern.edu",{"name":31,"role":38,"phone":12,"phoneExt":12,"email":42},"roy.heyne@utsouthwestern.edu",[44],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Parkland Health & Hospital System","RECRUITING","Dallas","Texas","75235","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-96.80667,32.78306,{"lat":56,"lon":55},[59,61],{"name":27,"role":38,"phone":60,"phoneExt":12,"email":40},"405-596-2075",{"name":31,"role":38,"phone":12,"phoneExt":12,"email":42},{"type":29,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"Margaret Hoge","Assistant Professor",[66],{"name":35,"class":6},"100355322","preventing-vulnerable-child-syndrome-in-the-nicu-with-cognitive-behavioral-therapy-prevnt-trial-100355322",false,"NCT03906435","Preventing Vulnerable Child Syndrome in the NICU With Cognitive Behavioral Therapy (PreVNT Trial)","Parental Perception of Child Vulnerability in the NICU and Development Outcomes: A Randomized Control Trial Preventative Intervention With Cognitive Behavioral Therapy","PreVNT","Inclusion Criteria:\n\n* Born at Parkland Hospital\n* English or Spanish speaking mother +\u002F- father\n* ≤ 30.6 weeks gestation at birth\n* Survival to 33 weeks gestation\n\nExclusion Criteria:\n\n* Significant congenital anomalies\n* Child Protective Services (CPS) involvement or foster care placement -- Prior enrollment in this PreVNT study for an older sibling.",true,"ALL",{"count":78,"type":79},100,"ESTIMATED","INTERVENTIONAL",[82],"NA","This study is being done to see if outcomes for both a premature infant's parents and the infant born prematurely who have spent time in the neonatal intensive care unit (NICU) can be improved through parent cognitive behavioral therapy (CBT) sessions.",[85,86,87,88],"Premature Infant","Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse)","Development, Child","Parent-Child Relations",[90,91,22,92,93,94],"Vulnerable Child Syndrome","Neonatal Intensive Care Unit","Parental Perception of Child Vulnerability","Child Developmental Outcomes","Parent Mental Health","2025-06-10",{"date":97,"type":98},"2025-06-13","ACTUAL",{"date":100,"type":98},"2019-04-15",{"date":102,"type":79},"2026-12-01",{"name":5,"class":6},1]