- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT00619255
Adolescent Trauma Recovery and Stress Disorders Collaborative Care (ATRSCC) Model Program Trial (ATRSCC)
Maternal Child Health Bureau Adolescent Trauma Recovery and Stress Disorders Collaborative Care (ATRSCC) Model Program Trial
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Washington
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Seattle, Washington, Spojené státy, 98104
- Harborview Medical Center
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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.
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Žádný zásah: Control
Usual Care Control Condition
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Number of Patients With High Levels of Adolescent PTSD Symptoms
Časové okno: 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.
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Baseline (injury), then 2, 5, and 12 months post-injury
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Number of Patients Who Self-reported Alcohol Consumption or Drug Use
Časové okno: Baseline (injury), and 2, 5, and 12 months post-injury
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Any self-reported alcohol or drug use using one yes or no question
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Baseline (injury), and 2, 5, and 12 months post-injury
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Percentage of Asolescents Linked to Primary Care During the Study
Časové okno: Up to12 months post-injury
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Percentage of adolescents self-reporting one or more primary care visits over the course of the 12-months after the injury
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Up to12 months post-injury
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Percentage of Adolescents Who Self-reported Weapon Carriage
Časové okno: Baseline (injury), then 2, 5, and 12 months post-injury
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Self-reported carrying of knife, gun, club or other weapon by adolescent
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Baseline (injury), then 2, 5, and 12 months post-injury
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Number of Patients Experiencing High-Level Depressive Symptoms
Časové okno: Baseline (injury), then 2, 5, and 12 months post-injury
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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.
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Baseline (injury), then 2, 5, and 12 months post-injury
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Douglas F. Zatzick, MD, University of Washington
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 32685
- 1 H34 MC08508-01-00
- 07-7850-C01 (Jiný identifikátor: University of Washington)
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
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