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

Part of paid clinical trials in Charleston, South Carolina.

Sponsor
Medical University of South Carolina
Study ID
NCT05086757
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 17 Years
Healthy Volunteers
Accepted

Interventions

  • TRRP — BEHAVIORAL
    Receive TRRP services
  • Enhanced Usual Care — BEHAVIORAL
    Participants will receive an educational flyer with service referrals

Study Details

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.

Key Dates

Start date
Jul 1, 2022
Status verified
Aug 2025
Primary completion
Aug 1, 2026
Completion
Aug 30, 2027

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

Primary Outcome Measure

The Child PTSD Symptom Scale, Caregiver/Child Version (CPSS) [ Time Frame: 3 months post-baseline assessment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Medical University of South CarolinaCharlestonSouth Carolina29466
Tatiana M Davidson, PhD
[email protected]
843-792-1866
Ken Ruggiero, PhD
[email protected]

Find similar trials in Charleston, SC

By condition
PTSD (post-traumatic stress disorder)
By specialty
PsychiatryMental healthBehavioral health
By research site
Medical University of South Carolina· Charleston, SC

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