[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100487083":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":31,"locations":39,"responsibleParty":57,"collaborators":59,"id":62,"slug":25,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":25,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":25,"enrollmentInfo":70,"targetDuration":25,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":25,"overallStatus":42,"whyStopped":25,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Children's Hospital Medical Center, Cincinnati","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Road-to-recovery group (R2R)","EXPERIMENTAL","Usual medical care plus the R2R-TBI intervention (self-guided web-program)",[13],"Behavioral: Road-to-recovery",{"label":15,"type":16,"description":17,"interventionNames":18},"Internet resources comparison group (IRC)","ACTIVE_COMPARATOR","Usual medical care plus internet resources",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","Road-to-recovery","R2R-TBI is a self-guided web-based intervention that targets caregiver psychological functioning, parenting behaviors, and family functioning in the first three months following pediatric traumatic brain injury.",[15,9],null,[27],{"name":28,"affiliation":29,"role":30},"Shari Wade, PhD","CCHMC","PRINCIPAL_INVESTIGATOR",[32,36],{"name":28,"role":33,"phone":34,"phoneExt":25,"email":35},"CONTACT","5134610952","Shari.Wade@cchmc.org",{"name":37,"role":33,"phone":25,"phoneExt":25,"email":38},"Stacey Raj","rajs@xavier.edu",[40],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Cincinnati Children's Hospital Medical Center","RECRUITING","Cincinnati","Ohio","45229-3036","United States",{"type":48,"coordinates":49},"Point",[50,51],-84.51439,39.12711,{"lat":51,"lon":50},[54,56],{"name":55,"role":33,"phone":34,"phoneExt":25,"email":35},"Shari Wade",{"name":37,"role":33,"phone":25,"phoneExt":25,"email":38},{"type":58,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[60],{"name":61,"class":6},"Nationwide Children's Hospital","100487083",false,"NCT05622461","Setting Families on a Positive Path to Recovery After Pediatric TBI: Road-to-Recovery","Setting Families on a Positive Path to Recovery After Pediatric TBI: Road-to-Recovery, A Randomized Control Trial","Inclusion Criteria:\n\nCaregivers will be eligible if they are over 18 years of age, and if their child meets all of the following criteria:\n\n* Ages 3 months to 18 years at time of discharge from hospital\n* Sustained a complicated mild to severe TBI as defined by a Glasgow Coma Scale (GCS) of 13-15 with imagining abnormalities or GCS 3-12 with or without imaging abnormalities\n* Admitted overnight to the hospital\n* 0-3 months post-discharge\n\nExclusion Criteria:\n\nThe caregiver will be excluded from participation if any of the following occur:\n\n* Child did not survive the injury\n* Child sustained a non-blunt head trauma (e.g. gunshot wound)\n* Child does not reside with parent\u002Fcaregiver for study duration\n* English is not primary language spoken in the home","ALL","18 Years",{"count":71,"type":72},200,"ESTIMATED","INTERVENTIONAL",[75],"NA","This study has two main goals: 1) to refine and enhance the R2R-TBI intervention; and 2) to examine the efficacy of the R2R-TBI intervention in a randomized control trial. To achieve the second goal, we will employ a between-groups randomized treatment design with repeated measures at baseline, one-month post-randomization, and at a six-month follow-up. The two conditions will be: a) usual medical care plus access to internet resources regarding pediatric brain injury (Internet Resources Comparison group, IRC), and b) usual medical care plus the R2R-TBI intervention (Road-to-Recovery group, R2R-TBI).",[78,79,80,81,82,83],"Traumatic Brain Injury","Head Injury","Head Injuries, Closed","Brain Hemorrhage, Traumatic","Brain Edema","Intracranial Edema","2025-06-20",{"date":86,"type":87},"2025-06-25","ACTUAL",{"date":89,"type":87},"2023-02-13",{"date":91,"type":72},"2026-08-31",{"name":5,"class":6},1]