Ignite Creation Date:
2025-12-24 @ 6:58 PM
Ignite Modification Date:
2026-01-01 @ 9:46 AM
Study NCT ID:
NCT05086757
Status:
RECRUITING
Last Update Posted:
2025-08-11
First Post:
2021-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Trauma Center-Based Intervention for Adolescent Traumatic Injury Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Trained interviewers blinded to condition will administer the 3-, 6-, and 12-month post-baseline assessments'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-08', 'studyFirstSubmitDate': '2021-09-08', 'studyFirstSubmitQcDate': '2021-10-08', 'lastUpdatePostDateStruct': {'date': '2025-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Child PTSD Symptom Scale, Caregiver/Child Version (CPSS)', 'timeFrame': '3 months post-baseline assessment', 'description': 'The CPSS is a 26-item measure to assess PTSD diagnostic criteria and severity in youth. Responses are assessed using a 4-point Likert scale and a cutoff score of 31 can be used for identifying a probable PTSD diagnosis in children.'}, {'measure': 'The Center for Epidemiological Studies Depression Scale (CES-DC)', 'timeFrame': '3 months post-baseline assessment', 'description': 'This is a 20-item measure of depression with strong psychometric properties. Responses are assessed using a 4-point Likert scale and a cutoff score of 15 is suggestive of depressive symptoms in children and adolescents.'}], 'secondaryOutcomes': [{'measure': 'Kessler 6', 'timeFrame': 'Baseline, 3, 6, and 12-month post-baseline assessment', 'description': 'This is a 6-item well-validated screening scale for nonspecific distress that demonstrates solid psychometric properties. Responses are assessed on a 5-point Likert scale and scores 13 or higher are suggestive of severe mental illness.'}, {'measure': 'Peritraumatic Distress Inventory (PDI)', 'timeFrame': 'Baseline', 'description': 'This is a 13-item measure with strong psychometric properties used to assess distress at the time of injury. Responses are on a 4-point Likert scale and scores above 15 are suggestive of peritraumatic distress. This measure has been validated with child traumatic injury survivors.'}, {'measure': 'Injured Trauma Survivor Screen (ITSS)', 'timeFrame': 'Baseline', 'description': 'This is a 9-item measure used to assess risk for development of posttraumatic stress symptoms following injury. Responses are in Yes/No format and a score of 2 on the PTSD questions suggest higher risk of developing PTSD and a score of 2 or more on the depression questions indicate higher risk for development of depression.'}, {'measure': 'The Alcohol Use Disorders Identification Test-Consumption (AUDIT-C)', 'timeFrame': 'Baseline, 3, 6, and 12-month post-baseline assessment', 'description': "This is a 3-item validated screen that identifies hazardous drinkers. The AUDIT-C is scored on a scale of 0-12 (scores of 0 reflect no alcohol use). In men, a score of 4 or more is considered positive; in women, a score of 3 or more is considered positive. Generally, the higher the AUDIT-C score, the more likely it is that the patient's drinking is affecting his/her health and safety."}, {'measure': 'Social Support Questionnaire, Short Form (SSQ6)', 'timeFrame': 'Baseline, 3, 6, and 12-month post-baseline assessment', 'description': 'This is a 6-item measure of social support that includes both availability and satisfaction with social support.'}, {'measure': 'Pediatric Quality of Life Inventory, Short Form (Peds QL-SF15)', 'timeFrame': 'Baseline, 3, 6, and 12-month post-baseline assessment', 'description': 'This is a 15-item measure to assess health related QoL in youth with acute/chronic health conditions. Responses are assessed using a 5-point Likert scale with higher scores being indicative of higher health-related quality of life.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Traumatic Injury', 'Technology', 'Posttraumatic Stress Disorder', 'Adolescents']}, 'descriptionModule': {'briefSummary': "Pediatric traumatic injury (i.e., injury of sudden onset and severity requiring immediate attention) is the leading cause of death and morbidity among US adolescents and are associated with mental health and health risk outcomes, including posttraumatic stress and depression (affecting between 19-42%), deficits in physical recovery, social functioning and quality of life, which if unaddressed, may contribute to increased use of health care services. The investigators partnered with three accredited Level I and II pediatric trauma centers to conduct a multi-site hybrid 1 effectiveness-implementation trial with 300 adolescent (ages 12-17) traumatic injury patients to assess the extent to which the Trauma Resilience and Recovery Program (TRRP), a scalable and sustainable, technology-enhanced, multidisciplinary stepped model of care, promotes improvement in quality of life and emotional recovery and gather preliminary data on the potential for TRRP to be implemented in other Level I trauma centers. Directly in line with NICHD's Pediatric Trauma and Critical Illness Research and Training (PTCIB) Strategic Research and Training agenda, this study will provide valuable data on the efficacy, preliminary effectiveness and potential for implementation of an innovative, cost-effective, sustainable technology-enhanced intervention designed to address the unique needs of adolescent injury patients and mitigate short- and long-term impact of injury on mental health, quality of life, and overall well-being.", 'detailedDescription': "Pediatric traumatic injury (i.e., injury of sudden onset and severity requiring immediate attention) is the leading cause of death and morbidity among US adolescents and are associated with mental health and health risk outcomes. Pediatric traumatic injuries are associated with medical and societal costs of $87 billion and elevates risk for a wide range of health risk consequences that affect quality of life, physical recovery, social functioning, and return to previous activities. The prevalence of PTSD and depression is high among pediatric traumatic injury patients; however, most pediatric trauma centers don't have the resources to implement models of care that address mental health following injury. Current guidelines by the American College of Surgeons (ACS) Committee on Trauma strongly recommend screening and addressing emotional recovery in traumatic injury patients. The ACS Committee on Trauma has identified this as a priority and likely will begin to mandate mental health programs in Level I and II pediatric trauma centers nationally. It is therefore critical that policy and practice is guided by the implementation and evaluation of scalable and sustainable models of care. In 2015 the investigators launched the Trauma Resilience and Recovery Program (TRRP), a scalable and sustainable, technology-enhanced, multidisciplinary stepped model of care - one of the few in the US - that provides early intervention and direct services to improve access to evidence-based mental health care after traumatic injury for children, adults and families. This model of care has been found to be feasible and acceptable to adolescent patients (ages 12-17) at each level of service. TRRP includes 3 major steps: (1) in-hospital education, brief risk reduction session, and tracking patients' emotional recovery via an automated text-messaging system, (2) conducting a 30-day screen via telephone to identify patients who are good candidates for psychological treatment, and (3) providing referral to best-practice telehealth-based or in-person assessment and treatment. The investigators partnered with three accredited Level I and II pediatric trauma centers and propose a multi-site hybrid 1 effectiveness-implementation trial with 300 adolescent (ages 12-17) traumatic injury patients to: 1) assess the extent to which TRRP promotes improvement in quality of life and emotional recovery and 2) gather preliminary data on the potential for TRRP to be implemented in other Level I trauma centers. Directly in line with NICHD's Pediatric Trauma and Critical Illness Research and Training (PTCIB) Strategic Research and Training agenda, this study will provide valuable data on the efficacy, preliminary effectiveness and potential for implementation of an innovative, cost-effective, sustainable technology-enhanced intervention designed to address the unique needs of adolescent injury patients and mitigate short- and long-term impact of injury on mental health, quality of life, and overall well-being."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adolescent ages 12-17 admitted following traumatic injury\n* scored significantly on the peritraumatic distress scale (PDI / ITSS)\n\nExclusion Criteria:\n\n* if the injury was self-inflicted\n* injuries are so severe, they prevent participation (e.g., head or spinal cord injuries that prevent verbal communication)'}, 'identificationModule': {'nctId': 'NCT05086757', 'briefTitle': 'Evaluation of Trauma Center-Based Intervention for Adolescent Traumatic Injury Survivors', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of South Carolina'}, 'officialTitle': 'Evaluation of Trauma Center-Based, Technology Enhanced Stepped Care Intervention for Adolescent Traumatic Injury Survivors.', 'orgStudyIdInfo': {'id': '111879'}, 'secondaryIdInfos': [{'id': '1R01HD102336-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R01HD102336-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Trauma Resilience and Recovery Program (TRRP)', 'description': "Enrollment in TRRP which includes 3 major steps: (1) in-hospital education, brief risk reduction session, and tracking patients' emotional recovery via an automated text-messaging system, (2) conducting a 30-day screen via telephone to identify patients who are good candidates for psychological treatment, and (3) providing referral to formal mental health services, if needed.", 'interventionNames': ['Behavioral: TRRP']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Enhanced Usual Care', 'description': 'Receive brief education about mental health after traumatic injury, educational materials about mental health recovery, and local referral information to assist treatment-seeking patients in seeking care', 'interventionNames': ['Behavioral: Enhanced Usual Care']}], 'interventions': [{'name': 'TRRP', 'type': 'BEHAVIORAL', 'description': 'Receive TRRP services', 'armGroupLabels': ['Trauma Resilience and Recovery Program (TRRP)']}, {'name': 'Enhanced Usual Care', 'type': 'BEHAVIORAL', 'description': 'Participants will receive an educational flyer with service referrals', 'armGroupLabels': ['Enhanced Usual Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29466', 'city': 'Charleston', 'state': 'South Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Tatiana M Davidson, PhD', 'role': 'CONTACT', 'email': 'davidst@musc.edu', 'phone': '843-792-1866'}, {'name': 'Ken Ruggiero, PhD', 'role': 'CONTACT', 'email': 'ruggierk@musc.edu'}], 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}], 'centralContacts': [{'name': 'Tatiana M Davidson, PhD', 'role': 'CONTACT', 'email': 'davidst@musc.edu', 'phone': '843-792-1866'}, {'name': 'Sarah German, BS', 'role': 'CONTACT', 'email': 'germansa@musc.edu', 'phone': '843-792-0979'}], 'overallOfficials': [{'name': 'Tatiana Davidson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of South Carolina'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of South Carolina', 'class': 'OTHER'}, 'collaborators': [{'name': "Children's of Alabama", 'class': 'OTHER'}, {'name': "Boston Children's Hospital", 'class': 'OTHER'}, {'name': 'Prisma Health-Upstate', 'class': 'OTHER'}, {'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}