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

NCT05086757 | Recruiting DMC

• 2 other identifiers: 1118791R01HD102336-01A1
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Injury; Technology; Posttraumatic Stress Disorder; Adolescents

Outcome Measures

Primary Outcomes (2)

• 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.

  3 months post-baseline assessment

• 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.

  3 months post-baseline assessment

Secondary Outcomes (6)

• Kessler 6

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

• Peritraumatic Distress Inventory (PDI)

  Baseline

• Injured Trauma Survivor Screen (ITSS)

  Baseline

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

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

• Social Support Questionnaire, Short Form (SSQ6)

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

Study Arms (2)

Trauma Resilience and Recovery Program (TRRP)

EXPERIMENTAL

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.

Behavioral: TRRP

Enhanced Usual Care

ACTIVE COMPARATOR

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

Behavioral: Enhanced Usual Care

Interventions

TRRP BEHAVIORAL

Receive TRRP services

Trauma Resilience and Recovery Program (TRRP)

Enhanced Usual Care BEHAVIORAL

Participants will receive an educational flyer with service referrals

Enhanced Usual Care

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of South Carolina: lead
• 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

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29466, United States

RECRUITING

MeSH Terms

Conditions

Wounds and Injuries; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Tatiana Davidson, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tatiana M Davidson, PhD

CONTACT

843-792-1866; davidst@musc.edu

Sarah German, BS

CONTACT

843-792-0979; germansa@musc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Trained interviewers blinded to condition will administer the 3-, 6-, and 12-month post-baseline assessments
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2021
• First Posted: October 21, 2021
• Study Start: July 1, 2022
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 30, 2027
• Last Updated: August 11, 2025

Record last verified: 2025-08

Locations

US (1)