Ignite Creation Date:
2025-12-24 @ 12:30 PM
Ignite Modification Date:
2025-12-28 @ 8:14 PM
Study NCT ID:
NCT05622461
Status:
RECRUITING
Last Update Posted:
2025-06-25
First Post:
2022-10-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Setting Families on a Positive Path to Recovery After Pediatric TBI: Road-to-Recovery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D016489', 'term': 'Head Injuries, Closed'}, {'id': 'D020201', 'term': 'Brain Hemorrhage, Traumatic'}, {'id': 'D001929', 'term': 'Brain Edema'}], 'ancestors': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D014949', 'term': 'Wounds, Nonpenetrating'}, {'id': 'D020198', 'term': 'Intracranial Hemorrhage, Traumatic'}, {'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-20', 'studyFirstSubmitDate': '2022-10-24', 'studyFirstSubmitQcDate': '2022-11-14', 'lastUpdatePostDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Moderators of treatment effects', 'timeFrame': '4-6 weeks', 'description': 'Examining household income and baseline caregiver distress as moderator of treatment effects'}, {'measure': 'Moderators of treatment effects', 'timeFrame': '6 months', 'description': 'Examining household income and baseline caregiver distress as moderator of treatment effects'}], 'primaryOutcomes': [{'measure': 'Parent anxiety', 'timeFrame': 'Change from baseline at 4-6 weeks post-intervention', 'description': 'Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Measure 4a; scores range from 4-20 with higher score indicating greater symptoms of anxiety'}, {'measure': 'Parent anxiety', 'timeFrame': 'Change from baseline at 6 months', 'description': 'Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Measure 4a; scores range from 4-20 with higher score indicating greater symptoms of anxiety'}, {'measure': 'Parent depression', 'timeFrame': 'Change from baseline at 4-6 weeks post-intervention', 'description': 'Center for Epidemiological Studies Depression Scale (CES-D; 10-items); scores range from 0 -30 with higher scores indicating of higher levels of depressive symptomatology'}, {'measure': 'Parent depression', 'timeFrame': 'Change from baseline at 6 months', 'description': 'Center for Epidemiological Studies Depression Scale (CES-D; 10-items); scores range from 0 -30 with higher scores indicating of higher levels of depressive symptomatology'}, {'measure': 'Parenting self-efficacy', 'timeFrame': 'Change from baseline at 4-6 weeks post-intervention', 'description': 'Caregiver self-efficacy scale (CSES); scores range from 25-100, higher scores indicate greater parenting self efficacy'}, {'measure': 'Parenting self-efficacy', 'timeFrame': 'Change from baseline at 6 months', 'description': 'Caregiver self-efficacy scale (CSES); scores range from 25-100, higher scores indicate greater parenting self efficacy'}, {'measure': 'Parent post-traumatic symptoms', 'timeFrame': 'Change from baseline at 4-6 weeks post-intervention', 'description': 'Primary Care PTSD Screen for DSM-5 (PC-PTSD-5); scores rage from 0-5 with higher scores indicating greater experience of post-traumatic stress symptoms'}, {'measure': 'Parent post-traumatic symptoms', 'timeFrame': 'Change from baseline at 6 months', 'description': 'Primary Care PTSD Screen for DSM-5 (PC-PTSD-5); scores rage from 0-5 with higher scores indicating greater experience of post-traumatic stress symptoms'}], 'secondaryOutcomes': [{'measure': 'Family Functioning', 'timeFrame': 'Change from baseline at 4-6 weeks post-intervention', 'description': 'Family Assessment Device - Global Functioning Scale. Scores range from 1 to 4 with higher scores indicating poorer family functioning'}, {'measure': 'Family Functioning', 'timeFrame': 'Change from baseline at 6 months', 'description': 'Family Assessment Device - Global Functioning Scale. Scores range from 1 to 4 with higher scores indicating poorer family functioning'}, {'measure': 'Family Burden of Injury', 'timeFrame': 'Change from baseline at 4-6 weeks post-intervention', 'description': 'Family Burden of Injury Interview (FBII). Average scores range from 0-4; higher scores indicate greater injury-related burden'}, {'measure': 'Family Burden of Injury', 'timeFrame': 'Change from baseline at 6 months', 'description': 'Family Burden of Injury Interview (FBII). Average scores range from 0-4; higher scores indicate greater injury-related burden'}, {'measure': 'Child Socioemotional Functioning', 'timeFrame': 'Change from baseline at 4-6 weeks post-intervention', 'description': 'Pediatric Quality of Life Scale (PEDS-QL) - Psychosocial Health Summary Score (score range varies based on child age; higher scores indicate greater health related quality of life)'}, {'measure': 'Child Socioemotional Functioning', 'timeFrame': 'Change from baseline at 6 months', 'description': 'Pediatric Quality of Life Scale (PEDS-QL) - Psychosocial Health Summary Score (score range varies based on child age; higher scores indicate greater health related quality of life)'}, {'measure': 'Parent mindful self-care', 'timeFrame': 'Change from baseline at 4-6 weeks post-intervention', 'description': 'Mindful self-care scale (MSCS); scores range from 6 - 30, higher scores denote greater frequency in engaging in self-care behaviors'}, {'measure': 'Parent mindful self-care', 'timeFrame': 'Change from baseline at 6 months', 'description': 'Mindful self-care scale (MSCS); scores range from 6 - 30, higher scores denote greater frequency in engaging in self-care behaviors'}, {'measure': 'Parent resilience', 'timeFrame': 'Change from baseline at 4-6 weeks post-intervention', 'description': 'Connor-Davidson Resilience Scale (CDRI); scores range from 0-40 with higher scored indicating greater resilience'}, {'measure': 'Parent resilience', 'timeFrame': 'Change from baseline at 6 months', 'description': 'Connor-Davidson Resilience Scale (CDRI); scores range from 0-40 with higher scored indicating greater resilience'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Traumatic Brain Injury', 'Head Injury', 'Head Injuries, Closed', 'Brain Hemorrhage, Traumatic', 'Brain Edema', 'Intracranial Edema']}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': 'The early recovery period constitutes a critical window to set families on a positive road-to-recovery by supporting parental self-care, positive parent-child interactions, and awareness of potential longer-term concerns. The latter would facilitate parental recognition of behavioral and psychosocial needs that might otherwise go unmet.\n\nRecognizing that (1) caregivers of children who have sustained TBI are at risk of worsening psychological health and that (2) caregiver functioning and parenting behaviors have a direct impact on child recovery and outcomes; intervening and supporting caregivers in the acute phase following injury may set children and families on a positive path to recovery. Intervening at the acute phase may reduce the cascading effects of parental burden/distress and concomitant negative parent-child interactions on child recovery and functioning over time.\n\nBecause families of children with TBI and other chronic health conditions may have difficulty accessing services due to transportation and cost issues, particularly lower income families, the R2R-TBI program is designed to be accessed via any web-enabled device (e.g., smartphone, computer, tablet) with any form of internet connection. We will also offer the intervention (via tablet) to parents while they wait for their child to complete outpatient therapies (e.g., speech, physical, and occupational therapy). Delivery of web-based behavioral health interventions may reduce barriers to help-seeking and promote evidence-based interventions that are both accessible and efficient.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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/caregiver for study duration\n* English is not primary language spoken in the home'}, 'identificationModule': {'nctId': 'NCT05622461', 'briefTitle': 'Setting Families on a Positive Path to Recovery After Pediatric TBI: Road-to-Recovery', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital Medical Center, Cincinnati"}, 'officialTitle': 'Setting Families on a Positive Path to Recovery After Pediatric TBI: Road-to-Recovery, A Randomized Control Trial', 'orgStudyIdInfo': {'id': '2022-0221'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Road-to-recovery group (R2R)', 'description': 'Usual medical care plus the R2R-TBI intervention (self-guided web-program)', 'interventionNames': ['Behavioral: Road-to-recovery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Internet resources comparison group (IRC)', 'description': 'Usual medical care plus internet resources', 'interventionNames': ['Behavioral: Road-to-recovery']}], 'interventions': [{'name': 'Road-to-recovery', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Internet resources comparison group (IRC)', 'Road-to-recovery group (R2R)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45229-3036', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Shari Wade', 'role': 'CONTACT', 'email': 'Shari.Wade@cchmc.org', 'phone': '5134610952'}, {'name': 'Stacey Raj', 'role': 'CONTACT', 'email': 'rajs@xavier.edu'}], 'facility': "Cincinnati Children's Hospital Medical Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'centralContacts': [{'name': 'Shari Wade, PhD', 'role': 'CONTACT', 'email': 'Shari.Wade@cchmc.org', 'phone': '5134610952'}, {'name': 'Stacey Raj', 'role': 'CONTACT', 'email': 'rajs@xavier.edu'}], 'overallOfficials': [{'name': 'Shari Wade, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CCHMC'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Starting 6 months after publication', 'ipdSharing': 'YES', 'description': 'Plan is to share deidentified data as consistent with requirement of funding source (i.e., The National Institute on Disability and Rehabilitation Research).', 'accessCriteria': 'Plan is to share deidentified data as consistent with protocols of funding source (i.e., The National Institute on Disability and Rehabilitation Research).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital Medical Center, Cincinnati", 'class': 'OTHER'}, 'collaborators': [{'name': "Nationwide Children's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}