NCT00619255

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 20, 2008

Completed
10 days until next milestone

Study Start

First participant enrolled

March 1, 2008

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2010

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

November 7, 2017

Completed
Last Updated

February 19, 2018

Status Verified

February 1, 2018

Enrollment Period

2.7 years

First QC Date

February 6, 2008

Results QC Date

July 3, 2017

Last Update Submit

February 16, 2018

Conditions

Keywords

AdolescentsQuality Assurance and ImprovementSubstance AbusePosttraumatic StressFamily Centered CareTrauma Systems

Outcome Measures

Primary Outcomes (1)

  • Number of Patients With High Levels of Adolescent PTSD Symptoms

    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

Secondary Outcomes (4)

  • Number of Patients Who Self-reported Alcohol Consumption or Drug Use

    Baseline (injury), and 2, 5, and 12 months post-injury

  • Percentage of Asolescents Linked to Primary Care During the Study

    Up to12 months post-injury

  • Percentage of Adolescents Who Self-reported Weapon Carriage

    Baseline (injury), then 2, 5, and 12 months post-injury

  • Number of Patients Experiencing High-Level Depressive Symptoms

    Baseline (injury), then 2, 5, and 12 months post-injury

Study Arms (2)

Intervention

EXPERIMENTAL

Adolescent Trauma Support Program

Behavioral: Adolescent Trauma Support Program

Control

NO INTERVENTION

Usual Care Control Condition

Interventions

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.

Intervention

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Related Publications (1)

  • Zatzick D, Russo J, Lord SP, Varley C, Wang J, Berliner L, Jurkovich G, Whiteside LK, O'Connor S, Rivara FP. Collaborative care intervention targeting violence risk behaviors, substance use, and posttraumatic stress and depressive symptoms in injured adolescents: a randomized clinical trial. JAMA Pediatr. 2014 Jun;168(6):532-9. doi: 10.1001/jamapediatrics.2013.4784.

Related Links

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticAlcoholismSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersAlcohol-Related DisordersChemically-Induced Disorders

Results Point of Contact

Title
Doug Zatzick, MD
Organization
University of Washington

Study Officials

  • Douglas F. Zatzick, MD

    University of Washington

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 6, 2008

First Posted

February 20, 2008

Study Start

March 1, 2008

Primary Completion

October 31, 2010

Study Completion

June 1, 2014

Last Updated

February 19, 2018

Results First Posted

November 7, 2017

Record last verified: 2018-02

Locations