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

16 février 2018 mis à jour par: 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.

Aperçu de l'étude

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

120

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • Washington
      • Seattle, Washington, États-Unis, 98104
        • Harborview Medical Center

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

12 ans à 18 ans (Enfant, Adulte)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Aucune intervention: Control
Usual Care Control Condition

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Number of Patients With High Levels of Adolescent PTSD Symptoms
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Number of Patients Who Self-reported Alcohol Consumption or Drug Use
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: Douglas F. Zatzick, MD, University of Washington

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 mars 2008

Achèvement primaire (Réel)

31 octobre 2010

Achèvement de l'étude (Réel)

1 juin 2014

Dates d'inscription aux études

Première soumission

6 février 2008

Première soumission répondant aux critères de contrôle qualité

6 février 2008

Première publication (Estimation)

20 février 2008

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

19 février 2018

Dernière mise à jour soumise répondant aux critères de contrôle qualité

16 février 2018

Dernière vérification

1 février 2018

Plus d'information

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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