Clinical trial NCT05086757: Evaluation of Trauma Center-Based Intervention for Adolescent Traumatic Injury Survivors
Official title: Evaluation of Trauma Center-Based, Technology Enhanced Stepped Care Intervention for Adolescent Traumatic Injury Survivors.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Traumatic Injury
Technology
Posttraumatic Stress Disorder
Adolescents
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: Children's of Alabama
name: Boston Children's Hospital
name: Prisma Health-Upstate
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2021-10-21
Enrollment: 300
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* adolescent ages 12-17 admitted following traumatic injury
* scored significantly on the peritraumatic distress scale (PDI / ITSS)

Exclusion Criteria:

* if the injury was self-inflicted
* injuries are so severe, they prevent participation (e.g., head or spinal cord injuries that prevent verbal communication)

Primary outcomes:
measure: The Child PTSD Symptom Scale, Caregiver/Child Version (CPSS)
timeFrame: 3 months post-baseline assessment
measure: The Center for Epidemiological Studies Depression Scale (CES-DC)
timeFrame: 3 months post-baseline assessment
Secondary outcomes:
measure: Kessler 6
timeFrame: Baseline, 3, 6, and 12-month post-baseline assessment
measure: Peritraumatic Distress Inventory (PDI)
timeFrame: Baseline
measure: Injured Trauma Survivor Screen (ITSS)
timeFrame: Baseline
measure: The Alcohol Use Disorders Identification Test-Consumption (AUDIT-C)
timeFrame: Baseline, 3, 6, and 12-month post-baseline assessment
measure: Social Support Questionnaire, Short Form (SSQ6)
timeFrame: Baseline, 3, 6, and 12-month post-baseline assessment
measure: Pediatric Quality of Life Inventory, Short Form (Peds QL-SF15)
timeFrame: Baseline, 3, 6, and 12-month post-baseline assessment
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Tatiana Davidson, PhD
role: PRINCIPAL_INVESTIGATOR
References: