[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100581880":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":28,"locations":37,"responsibleParty":102,"collaborators":104,"id":110,"slug":111,"hasResults":112,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":12,"eligibilityCriteria":116,"healthyVolunteers":117,"sex":118,"minAge":119,"maxAge":12,"enrollmentInfo":120,"targetDuration":12,"studyType":123,"phases":124,"briefSummary":126,"conditions":127,"keywords":12,"overallStatus":40,"whyStopped":12,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":141},{"fullName":5,"class":6},"Medical University of South Carolina","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Enhanced usual care (EUC)","NO_INTERVENTION","Educational packet includes behavioral health education for children and families after pediatric traumatic injury(PTI).",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Caregivers' Aid to Accelerate Recovery after pediatric Emergencies (CAARE)","EXPERIMENTAL","CAARE provides bedside screening and education, digital health tools to help caregivers track and manage emotional and behavioral recovery, and timely follow-up to facilitate screening and referrals (if needed). The 4 steps are: (1) a brief bedside intervention for caregivers and children with positive acute stress risk screens designed to provide coping skills and reduce distress; (2) technology resources including (a) a text message-based tool to facilitate symptom self-monitoring and (b) an mHealth application with embedded learning, coping skills, and service locator tools; (3) a 30-day behavioral health screening, and (4) referral to evidence-based treatment for children and caregivers with positive screens.",[18],"Behavioral: Caregivers' Aid to Accelerate Recovery after pediatric Emergencies (CAARE)",[20],{"type":21,"name":14,"description":22,"armGroupLabels":23,"otherNames":12},"BEHAVIORAL","CAARE is a technology-enhanced stepped model of care that is designed to deliver education at the bedside to caregivers of children under age 12 years hospitalized for pediatric injury about mental health recovery after pediatric injury as well as risk assessment and brief intervention for high-risk patients (Step 1), foster symptom self-monitoring and reinforcement of coping skills via mHealth tools (Step 2), screen for caregivers' and children's PTSD and depression 30 days post-injury (Step 3), and provide a referral and warm hand-off to mental health services if needed (Step 4).",[14],[25],{"name":26,"affiliation":5,"role":27},"Leigh Ridings, Ph.D.","PRINCIPAL_INVESTIGATOR",[29,34],{"name":30,"role":31,"phone":32,"phoneExt":12,"email":33},"Leigh Ridings","CONTACT","(843) 792-5146","ridingle@musc.edu",{"name":35,"role":31,"phone":12,"phoneExt":12,"email":36},"Ebonie Powell","powelebo@musc.edu",[38,57,72,87],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Children's Hospital Los Angeles","RECRUITING","Los Angeles","California","90027","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-118.24368,34.05223,{"lat":50,"lon":49},[53],{"name":54,"role":31,"phone":55,"phoneExt":12,"email":56},"Ryan Spurrier","323.361.2322","rspurrier@chla.usc.edu",{"facility":58,"status":40,"city":59,"state":60,"zip":61,"country":44,"countryCode":45,"cosmosGeoPoint":62,"geoPoint":66,"contacts":67},"Kentucky Children's Hospital","Lexington","Kentucky","40536",{"type":47,"coordinates":63},[64,65],-84.47772,37.98869,{"lat":65,"lon":64},[68],{"name":69,"role":31,"phone":70,"phoneExt":12,"email":71},"Meghan Marsac","859-218-9113","meghan.marsac@uky.edu",{"facility":73,"status":40,"city":74,"state":75,"zip":76,"country":44,"countryCode":45,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"C.S. Mott Children's Hospital","Ann Arbor","Michigan","48109",{"type":47,"coordinates":78},[79,80],-83.74088,42.27756,{"lat":80,"lon":79},[83],{"name":84,"role":31,"phone":85,"phoneExt":12,"email":86},"Peter Ehrlich","(734) 763-2072","pehrlich@med.umich.edu",{"facility":88,"status":40,"city":89,"state":90,"zip":91,"country":44,"countryCode":45,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"Children's Memorial Hermann Hospital","Houston","Texas","77030",{"type":47,"coordinates":93},[94,95],-95.36327,29.76328,{"lat":95,"lon":94},[98],{"name":99,"role":31,"phone":100,"phoneExt":12,"email":101},"Linda Ewing-Cobbs","713-500-3873","Linda.Ewing-Cobbs@uth.tmc.edu",{"type":27,"investigatorFullName":30,"investigatorTitle":103,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"Assistant Professor-Faculty",[105,108],{"name":106,"class":107},"National Institutes of Health (NIH)","NIH",{"name":109,"class":107},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","100581880","improving-behavioral-health-for-caregivers-and-children-after-pediatric-injury-100581880",false,"NCT06856057","Improving Behavioral Health for Caregivers and Children After Pediatric Injury","Improving Quality of Life and Behavioral Health Service Access for Caregivers and Young Children After Pediatric Traumatic Injury","Inclusion Criteria:\n\n* Caregivers (≥18 years old) of children hospitalized with pediatric injury\n* Children hospitalized with pediatric injury \\<12 years old\n* Screen positive on the ASC-Kids (aged 8-11 years) or PDI Caregiver measure of acute distress.\n\nExclusion Criteria:\n\n* A caregiver whose primary language is not English\n* A cognitive challenge (caregiver or child) that would impair ability to consent\n* Presence of a self-afflicted injury\n* Presence of injuries resulting from caregiver abuse or neglect (these patients will follow an alternative treatment path).",true,"ALL","18 Years",{"count":121,"type":122},348,"ESTIMATED","INTERVENTIONAL",[125],"NA","Pediatric traumatic injury (PTI) is a public health priority, with more than 125,000 children experiencing injuries that require hospitalization each year. These children, and their caregivers, are affected in many ways that may affect quality of life, emotional and behavioral health, physical recovery, family roles and routines, and academic functioning; yet US trauma centers do not adequately address these outcomes and a scalable national model of care for these families is needed. This proposal builds on prior research from the investigative team to test a technology-assisted, stepped care behavioral health intervention for children (\\<12 years) and their caregivers after PTI, CAARE (Caregivers' Aid to Accelerate Recovery after pediatric Emergencies), via a hybrid type I effectiveness-implementation trial with 348 families randomly assigned to CAARE (n=174) vs. guideline-adherent enhanced usual care (EUC) (n=174).",[128,129,130,131],"Quality of Life","PTSD","Depression Not Otherwise Specified","Child Externalizing Behavior","2025-07-07",{"date":134,"type":135},"2025-07-10","ACTUAL",{"date":137,"type":135},"2025-05-28",{"date":139,"type":122},"2028-08-31",{"name":5,"class":6},4]