Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05086757 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Aug 1, 2026 → Aug 30, 2027
See other at-risk trials from Medical University of South Carolina

Record History

  1. Primary completion pushed from Aug 1, 2026 to Aug 30, 2027 Primary endpoints: details revised at 1 of 2 entries · Enrollment closed, study ongoing · Secondary endpoints: details revised at 5 of 6 entries · 4 more Show 7 more changesShow less
    • Primary endpoints: details revised at 1 of 2 entries
    • Enrollment closed, study ongoing
    • Secondary endpoints: details revised at 5 of 6 entries
    • Site details revised
    • Collaborators: details revised at 2 of 4 entries
    • Publications: details revised at 1 of 1 entry
    • Eligibility criteria expanded, about 4 words
  2. Primary completion date: Aug 1, 2025 to Aug 1, 2026 Completion date: Aug 30, 2026 to Aug 30, 2027v8 Show 1 more changeShow less
    • Completion date: Aug 30, 2026 to Aug 30, 2027
  3. Primary completion date: Feb 1, 2025 to Aug 1, 2025 Completion date: Aug 30, 2025 to Aug 30, 2026v7 Show 1 more changeShow less
    • Completion date: Aug 30, 2025 to Aug 30, 2026
  4. Primary completion date: Jan 1, 2025 to Feb 1, 2025v6
  5. Primary completion date: Mar 1, 2025 to Jan 1, 2025v5
Show 3 earlier versionsHide 3 earlier versions
  1. Primary completion date: Apr 1, 2025 to Mar 1, 2025v4
  2. Re-verified, no change to tracked fieldsv3
  3. Trial status: Not Yet Recruiting to Recruiting Site details revisedv2 Show 1 more changeShow less
    • Site details revised
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05086757
Lead Sponsor Medical University of South Carolina
Collaborators: Children's of Alabama, Boston Children's Hospital, Prisma Health-Upstate, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions Traumatic Injury, Technology, Posttraumatic Stress Disorder, Adolescents
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov