Recruiting

Trauma Intervention

Sponsor:

Medical University of South Carolina

Code:

NCT05086757

Conditions

Traumatic Injury

Technology

Posttraumatic Stress Disorder

Adolescents

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Accepted

Interventions

TRRP

Enhanced Usual Care

Study Details

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

Study ID

NCT05086757

Start date

Jul 1, 2022

Status verified date

Aug, 2025

Completion date

Aug 30, 2027

Anticipated

Primary completion date

Aug 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Trauma Resilience and Recovery Program (TRRP)

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.

active comparator: Enhanced Usual Care

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

Interventions

TRRP

Receive TRRP services

Enhanced Usual Care

Participants will receive an educational flyer with service referrals

Primary outcome measure

  • The Child PTSD Symptom Scale, Caregiver/Child Version (CPSS) [ Time Frame: 3 months post-baseline assessment ]
  • The Center for Epidemiological Studies Depression Scale (CES-DC) [ Time Frame: 3 months post-baseline assessment ]

Central Contacts and Locations

Central contacts

Locations

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29466

Contacts

Tatiana M Davidson, PhD

843-792-1866davidst@musc.edu

Ken Ruggiero, PhD

ruggierk@musc.edu

More Information

Sponsor

Medical University of South Carolina

Last update posted

Aug 11, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medical University of South Carolina on 2025-08-11.