- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Washington
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Seattle, Washington, Forente stater, 98104
- Harborview Medical Center
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 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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Ingen inngripen: Control
Usual Care Control Condition
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Number of Patients With High Levels of Adolescent PTSD Symptoms
Tidsramme: 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
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Number of Patients Who Self-reported Alcohol Consumption or Drug Use
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Douglas F. Zatzick, MD, University of Washington
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 32685
- 1 H34 MC08508-01-00
- 07-7850-C01 (Annen identifikator: University of Washington)
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