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

Primary Purpose

Post-traumatic Stress Disorder, Alcohol Abuse, Alcohol Dependence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Adolescent Trauma Support Program
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-traumatic Stress Disorder focused on measuring Adolescents, Quality Assurance and Improvement, Substance Abuse, Posttraumatic Stress, Family Centered Care, Trauma Systems

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Harborview Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

Adolescent Trauma Support Program

Usual Care Control Condition

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of Patients Who Self-reported Alcohol Consumption or Drug Use
Any self-reported alcohol or drug use using one yes or no question
Percentage of Asolescents Linked to Primary Care During the Study
Percentage of adolescents self-reporting one or more primary care visits over the course of the 12-months after the injury
Percentage of Adolescents Who Self-reported Weapon Carriage
Self-reported carrying of knife, gun, club or other weapon by adolescent
Number of Patients Experiencing High-Level Depressive Symptoms
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.

Full Information

First Posted
February 6, 2008
Last Updated
February 16, 2018
Sponsor
University of Washington
Collaborators
HRSA/Maternal and Child Health Bureau
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1. Study Identification

Unique Protocol Identification Number
NCT00619255
Brief Title
Adolescent Trauma Recovery and Stress Disorders Collaborative Care (ATRSCC) Model Program Trial
Acronym
ATRSCC
Official Title
Maternal Child Health Bureau Adolescent Trauma Recovery and Stress Disorders Collaborative Care (ATRSCC) Model Program Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
March 1, 2008 (Actual)
Primary Completion Date
October 31, 2010 (Actual)
Study Completion Date
June 1, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
HRSA/Maternal and Child Health Bureau

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-traumatic Stress Disorder, Alcohol Abuse, Alcohol Dependence
Keywords
Adolescents, Quality Assurance and Improvement, Substance Abuse, Posttraumatic Stress, Family Centered Care, Trauma Systems

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Adolescent Trauma Support Program
Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual Care Control Condition
Intervention Type
Behavioral
Intervention Name(s)
Adolescent Trauma Support Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Patients With High Levels of Adolescent PTSD Symptoms
Description
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.
Time Frame
Baseline (injury), then 2, 5, and 12 months post-injury
Secondary Outcome Measure Information:
Title
Number of Patients Who Self-reported Alcohol Consumption or Drug Use
Description
Any self-reported alcohol or drug use using one yes or no question
Time Frame
Baseline (injury), and 2, 5, and 12 months post-injury
Title
Percentage of Asolescents Linked to Primary Care During the Study
Description
Percentage of adolescents self-reporting one or more primary care visits over the course of the 12-months after the injury
Time Frame
Up to12 months post-injury
Title
Percentage of Adolescents Who Self-reported Weapon Carriage
Description
Self-reported carrying of knife, gun, club or other weapon by adolescent
Time Frame
Baseline (injury), then 2, 5, and 12 months post-injury
Title
Number of Patients Experiencing High-Level Depressive Symptoms
Description
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.
Time Frame
Baseline (injury), then 2, 5, and 12 months post-injury

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglas F. Zatzick, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24733515
Citation
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.
Results Reference
result
Links:
URL
http://depts.washington.edu/hcsats/
Description
Our study is no longer recruiting, if you are seeking care for PTSD from Harborview Medical Center please follow this link.

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

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