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Adolescent Trauma Recovery and Stress Disorders Collaborative Care (ATRSCC) Model Program Trial (ATRSCC)

16 febbraio 2018 aggiornato da: Douglas Zatzick, University of Washington

Maternal Child Health Bureau Adolescent Trauma Recovery and Stress Disorders Collaborative Care (ATRSCC) Model Program Trial

Recent needs assessments suggest that difficulties exist in care coordination between emergency medical services (EMS) systems and primary care for injured adolescents with alcohol problems and post-traumatic stress disorder (PTSD). This project will implement, evaluate, and disseminate the adolescent trauma support service model program that aims to enhance coordination between EMS systems and primary care/community services.

Panoramica dello studio

Descrizione dettagliata

Goal 1: To coordinate care from EMS systems to primary care for injured adolescents.

Objective 1: To increase rates of connection to primary care providers to 55% for model program adolescents, compared to an anticipated connection rate of 25% in adolescents assigned to standard care, by 2010.

Goal 2: To reduce alcohol consumption over the course of the year after injury.

Objective 2: To reduce rates of alcohol consumption by 25% in adolescents assigned to the model program, compared to adolescents assigned to the standard care, by 2010.

Goal 3: To reduce adolescent PTSD symptoms over the course of the year after injury.

Objective 3: To achieve statistically significant reductions in PTSD symptoms in model program patients, compared to adolescents assigned to standard care, by 2010.

Activities Undertaken to Meet Project Goals:

We propose to implement and evaluate an innovative model program, the adolescent trauma support service, that aims to improve the quality of care for injured adolescents with problematic alcohol use and high levels of PTSD symptoms by enhancing coordination of care between EMS systems and primary care and community services. All injured adolescents ages 12-18 presenting to the Harborview Medical Center with injuries so severe that they require inpatient admission and/or 24 hour observation in the emergency department, will be screened for alcohol use and PTSD. Adolescents who screen into the study will be randomly assigned to the adolescent trauma support service or standard care. Two trauma support specialists will meet each injured adolescent and available family members by the ED gurney or inpatient bedside in order to elicit and address each patient/family's unique constellation of post-injury concerns. Next, the adolescent trauma support specialist will help to coordinate care received within the EMS system with primary care providers. The trauma support specialists will also have the capacity to deliver evidence-based motivational interviewing interventions targeting reductions in adolescent alcohol use. The trauma support specialists will link patients and families to evidence-based PTSD treatment through primary care and community resources. Program evaluation will include a comparison of the outcomes of adolescents randomly assigned to the adolescent trauma support program with those of adolescents assigned to standard care. Adolescents in the model program and standard care will be compared on the presence or absence of post-injury primary care visits and reductions in alcohol use and PTSD symptoms over the course of the year after injury. Nationwide dissemination activities of program evaluation results will include the publication of manuscripts in peer reviewed journals and presentations at national meetings by members of the interdisciplinary collaborative group that includes pediatric, mental health and surgical providers.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

120

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Washington
      • Seattle, Washington, Stati Uniti, 98104
        • Harborview Medical Center

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 12 anni a 18 anni (Bambino, Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • The investigators will screen all English speaking female and male adolescents ages 12-18, who present to Harborview Medical Center with injuries so severe that they require inpatient admission and/or > 24 hour observation in the emergency department.
  • All dyads where both parents consent and adolescents assent to the study will be enrolled in the study and randomized.

Exclusion Criteria:

  • Adolescents who have suffered head, spinal cord, or other severe injuries that prevent participation in the baseline interview will be excluded from the protocol.
  • Patients who require immediate intervention (e.g., self-inflicted injury, active psychosis, mania, and victims of family abuse) will be excluded and referred to the Harborview Inpatient Psychiatric Consult Service.
  • Patients who are currently incarcerated or are likely to face criminal charges will be excluded.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Intervention
Adolescent Trauma Support Program
The study team will be organized into an adolescent trauma support service. The adolescent trauma support service will fundamentally restructure psychosocial care by integrating post-injury medical treatment with alcohol and PTSD detection and treatment. The adolescent trauma support specialists will deliver a stepped collaborative care intervention to adolescents and their families over the 6-12 months post-injury.
Nessun intervento: Control
Usual Care Control Condition

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Patients With High Levels of Adolescent PTSD Symptoms
Lasso di tempo: Baseline (injury), then 2, 5, and 12 months post-injury
Patients with symptoms consistent with a diagnosis of PTSD on the UCLA PTSD Reaction Index were counted. The UCLA PTSD-RI can be used to create an algorithm consistent with a diagnosis of PTSD by rating 1 intrusive, 3 avoidant, and 2 arousal symptoms with a rating of moderate severity. The PTSD-RI is scored on a scale from 0 (none of the time) - 4 (most of the time) with a > = 2 "some of the time" denoting this cutoff for moderate severity. This algorithm was used to identify patients with high PTSD symptom levels consistent with a diagnosis of PTSD.
Baseline (injury), then 2, 5, and 12 months post-injury

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Patients Who Self-reported Alcohol Consumption or Drug Use
Lasso di tempo: Baseline (injury), and 2, 5, and 12 months post-injury
Any self-reported alcohol or drug use using one yes or no question
Baseline (injury), and 2, 5, and 12 months post-injury
Percentage of Asolescents Linked to Primary Care During the Study
Lasso di tempo: Up to12 months post-injury
Percentage of adolescents self-reporting one or more primary care visits over the course of the 12-months after the injury
Up to12 months post-injury
Percentage of Adolescents Who Self-reported Weapon Carriage
Lasso di tempo: Baseline (injury), then 2, 5, and 12 months post-injury
Self-reported carrying of knife, gun, club or other weapon by adolescent
Baseline (injury), then 2, 5, and 12 months post-injury
Number of Patients Experiencing High-Level Depressive Symptoms
Lasso di tempo: Baseline (injury), then 2, 5, and 12 months post-injury
The investigators used the Patient Health Questionnaire (PHQ-9) to identify symptoms consistent with a diagnosis of depression on the 9-item Patient Health Questionnaire depression screen. Scores range from 1 to 27 with higher scores representing worse outcomes.
Baseline (injury), then 2, 5, and 12 months post-injury

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Douglas F. Zatzick, MD, University of Washington

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 marzo 2008

Completamento primario (Effettivo)

31 ottobre 2010

Completamento dello studio (Effettivo)

1 giugno 2014

Date di iscrizione allo studio

Primo inviato

6 febbraio 2008

Primo inviato che soddisfa i criteri di controllo qualità

6 febbraio 2008

Primo Inserito (Stima)

20 febbraio 2008

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

19 febbraio 2018

Ultimo aggiornamento inviato che soddisfa i criteri QC

16 febbraio 2018

Ultimo verificato

1 febbraio 2018

Maggiori informazioni

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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