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Evaluation of Trauma Center-Based Intervention for Adolescent Traumatic Injury Survivors

ConditionsTraumatic InjuryTechnologyPosttraumatic Stress DisorderAdolescents
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-17
SponsorMedical University of South Carolina

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

adolescent ages 12-17 admitted following traumatic injury

scored significantly on the peritraumatic distress scale (PDI / ITSS)

Disqualifiers

if the injury was self-inflicted

injuries are so severe, they prevent participation (e.g., head or spinal cord injuries that prevent verbal communication)

Trial design

Design model

Parallel

Treatments tested in this trial

  • TRRP

    Behavioral

    Receive TRRP services

  • Enhanced Usual Care

    Behavioral

    Participants will receive an educational flyer with service referrals

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Trauma Resilience and Recovery Program (TRRP)Experimental treatment 1 intervention
Group B: Enhanced Usual CareActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

The Child PTSD Symptom Scale, Caregiver/Child Version (CPSS)

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.

Time frame
3 months post-baseline assessment
2

The Center for Epidemiological Studies Depression Scale (CES-DC)

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.

Time frame
3 months post-baseline assessment

Secondary outcomes

1

Kessler 6

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.

Time frame
Baseline, 3, 6, and 12-month post-baseline assessment
2

Peritraumatic Distress Inventory (PDI)

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.

Time frame
Baseline
3

Injured Trauma Survivor Screen (ITSS)

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.

Time frame
Baseline
4

The Alcohol Use Disorders Identification Test-Consumption (AUDIT-C)

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.

Time frame
Baseline, 3, 6, and 12-month post-baseline assessment

Other outcomes

Sponsors and contacts

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Medical University of South Carolina

Lead sponsor

Children's of Alabama

Collaborator

Boston Children's Hospital

Collaborator

Prisma Health-Upstate

Collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Source ClinicalTrials.gov
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