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Идёт набор NCT05086757

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

Без фазы С лечением Traumatic Injury Technology Posttraumatic Stress Disorder Adolescents

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: TRRP, Enhanced Usual Care.
Кому может быть актуально
Состояния в реестре: Traumatic Injury, Technology, Posttraumatic Stress Disorder, Adolescents. Базовые параметры: 12 лет — 17 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Evaluation of Trauma Center-Based, Technology Enhanced Stepped Care Intervention for Adolescent Traumatic Injury Survivors.

Обзор

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.

Подробное описание

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. Pediatric traumatic injuries are associated with medical and societal costs of $87 billion and elevates risk for a wide range of health risk consequences that affect quality of life, physical recovery, social functioning, and return to previous activities. The prevalence of PTSD and depression is high among pediatric traumatic injury patients; however, most pediatric trauma centers don't have the resources to implement models of care that address mental health following injury. Current guidelines by the American College of Surgeons (ACS) Committee on Trauma strongly recommend screening and addressing emotional recovery in traumatic injury patients. The ACS Committee on Trauma has identified this as a priority and likely will begin to mandate mental health programs in Level I and II pediatric trauma centers nationally. It is therefore critical that policy and practice is guided by the implementation and evaluation of scalable and sustainable models of care. In 2015 the investigators launched the Trauma Resilience and Recovery Program (TRRP), a scalable and sustainable, technology-enhanced, multidisciplinary stepped model of care - one of the few in the US - that provides early intervention and direct services to improve access to evidence-based mental health care after traumatic injury for children, adults and families. This model of care has been found to be feasible and acceptable to adolescent patients (ages 12-17) at each level of service. TRRP 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 best-practice telehealth-based or in-person assessment and treatment. The investigators partnered with three accredited Level I and II pediatric trauma centers and propose a multi-site hybrid 1 effectiveness-implementation trial with 300 adolescent (ages 12-17) traumatic injury patients to: 1) assess the extent to which TRRP promotes improvement in quality of life and emotional recovery and 2) 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.

Вмешательства

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

Первичные конечные точки

  • The Child PTSD Symptom Scale, Caregiver/Child Version (CPSS) [Срок оценки: 3 months post-baseline assessment]
  • The Center for Epidemiological Studies Depression Scale (CES-DC) [Срок оценки: 3 months post-baseline assessment]
Вторичные конечные точки (6)
  • Kessler 6 [Срок оценки: Baseline, 3, 6, and 12-month post-baseline assessment]
  • Peritraumatic Distress Inventory (PDI) [Срок оценки: Baseline]
  • Injured Trauma Survivor Screen (ITSS) [Срок оценки: Baseline]
  • The Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) [Срок оценки: Baseline, 3, 6, and 12-month post-baseline assessment]
  • Social Support Questionnaire, Short Form (SSQ6) [Срок оценки: Baseline, 3, 6, and 12-month post-baseline assessment]
  • Pediatric Quality of Life Inventory, Short Form (Peds QL-SF15) [Срок оценки: Baseline, 3, 6, and 12-month post-baseline assessment]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Medical University of South Carolina — Charleston

Публикации

  • Davidson TM, Skojec T, Li P, Ridings LE, Espeleta H, German S, Mueller M, Gates R, Mooney D, Russell R, deRoon-Cassini T, Ruggiero K. Evaluation of a trauma center-based, technology enhanced stepped care intervention to promote the mental health recovery of adolescent traumatic injury survivors. Contemp Clin Trials Commun. 2026 Feb 24;50:101622. doi: 10.1016/j.conctc.2026.101622. eCollection 2026 PMID 41782923

Идентификаторы

NCT: NCT05086757 · 111879 · 1R01HD102336-01A1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗