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

16 februari 2018 bijgewerkt door: 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.

Studie Overzicht

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

120

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

    • Washington
      • Seattle, Washington, Verenigde Staten, 98104
        • Harborview Medical Center

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

12 jaar tot 18 jaar (Kind, Volwassen)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Geen tussenkomst: Control
Usual Care Control Condition

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of Patients With High Levels of Adolescent PTSD Symptoms
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of Patients Who Self-reported Alcohol Consumption or Drug Use
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: Douglas F. Zatzick, MD, University of Washington

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 maart 2008

Primaire voltooiing (Werkelijk)

31 oktober 2010

Studie voltooiing (Werkelijk)

1 juni 2014

Studieregistratiedata

Eerst ingediend

6 februari 2008

Eerst ingediend dat voldeed aan de QC-criteria

6 februari 2008

Eerst geplaatst (Schatting)

20 februari 2008

Updates van studierecords

Laatste update geplaatst (Werkelijk)

19 februari 2018

Laatste update ingediend die voldeed aan QC-criteria

16 februari 2018

Laatst geverifieerd

1 februari 2018

Meer informatie

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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