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Evaluation of Trauma Center-Based Intervention for Adolescent Traumatic Injury Survivors

Primary Purpose

Traumatic Injury, Technology, Posttraumatic Stress Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TRRP
Enhanced Usual Care
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Injury

Eligibility Criteria

12 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • adolescent ages 12-17 admitted following traumatic injury
  • scored significantly on the peritraumatic distress scale (PDI / ITSS)

Exclusion Criteria:

  • if the injury was self-inflicted
  • injuries are so severe, they prevent participation (e.g., head or spinal cord injuries that prevent verbal communication)

Sites / Locations

  • Medical University of South CarolinaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Trauma Resilience and Recovery Program (TRRP)

Enhanced Usual Care

Arm Description

Enrollment in TRRP which includes 3 major steps: (1) in-hospital education, brief risk reduction session, and tracking patients' emotional recovery via an automated text-messaging system, (2) conducting a 30-day screen via telephone to identify patients who are good candidates for psychological treatment, and (3) providing referral to formal mental health services, if needed.

Receive brief education about mental health after traumatic injury, educational materials about mental health recovery, and local referral information to assist treatment-seeking patients in seeking care

Outcomes

Primary Outcome Measures

The Child PTSD Symptom Scale, Caregiver/Child Version (CPSS)
The CPSS is a 26-item measure to assess PTSD diagnostic criteria and severity in youth. Responses are assessed using a 4-point Likert scale and a cutoff score of 31 can be used for identifying a probable PTSD diagnosis in children.
The Center for Epidemiological Studies Depression Scale (CES-DC)
This is a 20-item measure of depression with strong psychometric properties. Responses are assessed using a 4-point Likert scale and a cutoff score of 15 is suggestive of depressive symptoms in children and adolescents.

Secondary Outcome Measures

Kessler 6
This is a 6-item well-validated screening scale for nonspecific distress that demonstrates solid psychometric properties. Responses are assessed on a 5-point Likert scale and scores 13 or higher are suggestive of severe mental illness.
Peritraumatic Distress Inventory (PDI)
This is a 13-item measure with strong psychometric properties used to assess distress at the time of injury. Responses are on a 4-point Likert scale and scores above 15 are suggestive of peritraumatic distress. This measure has been validated with child traumatic injury survivors.
Injured Trauma Survivor Screen (ITSS)
This is a 9-item measure used to assess risk for development of posttraumatic stress symptoms following injury. Responses are in Yes/No format and a score of 2 on the PTSD questions suggest higher risk of developing PTSD and a score of 2 or more on the depression questions indicate higher risk for development of depression.
The Alcohol Use Disorders Identification Test-Consumption (AUDIT-C)
This is a 3-item validated screen that identifies hazardous drinkers. The AUDIT-C is scored on a scale of 0-12 (scores of 0 reflect no alcohol use). In men, a score of 4 or more is considered positive; in women, a score of 3 or more is considered positive. Generally, the higher the AUDIT-C score, the more likely it is that the patient's drinking is affecting his/her health and safety.
Social Support Questionnaire, Short Form (SSQ6)
This is a 6-item measure of social support that includes both availability and satisfaction with social support.
Pediatric Quality of Life Inventory, Short Form (Peds QL-SF15)
This is a 15-item measure to assess health related QoL in youth with acute/chronic health conditions. Responses are assessed using a 5-point Likert scale with higher scores being indicative of higher health-related quality of life.

Full Information

First Posted
September 8, 2021
Last Updated
August 23, 2023
Sponsor
Medical University of South Carolina
Collaborators
Children's of Alabama, Boston Children's Hospital, Prisma Health-Upstate, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT05086757
Brief Title
Evaluation of Trauma Center-Based Intervention for Adolescent Traumatic Injury Survivors
Official Title
Evaluation of Trauma Center-Based, Technology Enhanced Stepped Care Intervention for Adolescent Traumatic Injury Survivors.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
August 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
Collaborators
Children's of Alabama, Boston Children's Hospital, Prisma Health-Upstate, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Pediatric traumatic injury (i.e., injury of sudden onset and severity requiring immediate attention) is the leading cause of death and morbidity among US adolescents and are associated with mental health and health risk outcomes, including posttraumatic stress and depression (affecting between 19-42%), deficits in physical recovery, social functioning and quality of life, which if unaddressed, may contribute to increased use of health care services. The investigators partnered with three accredited Level I and II pediatric trauma centers to conduct a multi-site hybrid 1 effectiveness-implementation trial with 300 adolescent (ages 12-17) traumatic injury patients to assess the extent to which the Trauma Resilience and Recovery Program (TRRP), a scalable and sustainable, technology-enhanced, multidisciplinary stepped model of care, promotes improvement in quality of life and emotional recovery and gather preliminary data on the potential for TRRP to be implemented in other Level I trauma centers. Directly in line with NICHD's Pediatric Trauma and Critical Illness Research and Training (PTCIB) Strategic Research and Training agenda, this study will provide valuable data on the efficacy, preliminary effectiveness and potential for implementation of an innovative, cost-effective, sustainable technology-enhanced intervention designed to address the unique needs of adolescent injury patients and mitigate short- and long-term impact of injury on mental health, quality of life, and overall well-being.
Detailed Description
Pediatric traumatic injury (i.e., injury of sudden onset and severity requiring immediate attention) is the leading cause of death and morbidity among US adolescents and are associated with mental health and health risk outcomes. Pediatric traumatic injuries are associated with medical and societal costs of $87 billion and elevates risk for a wide range of health risk consequences that affect quality of life, physical recovery, social functioning, and return to previous activities. The prevalence of PTSD and depression is high among pediatric traumatic injury patients; however, most pediatric trauma centers don't have the resources to implement models of care that address mental health following injury. Current guidelines by the American College of Surgeons (ACS) Committee on Trauma strongly recommend screening and addressing emotional recovery in traumatic injury patients. The ACS Committee on Trauma has identified this as a priority and likely will begin to mandate mental health programs in Level I and II pediatric trauma centers nationally. It is therefore critical that policy and practice is guided by the implementation and evaluation of scalable and sustainable models of care. In 2015 the investigators launched the Trauma Resilience and Recovery Program (TRRP), a scalable and sustainable, technology-enhanced, multidisciplinary stepped model of care - one of the few in the US - that provides early intervention and direct services to improve access to evidence-based mental health care after traumatic injury for children, adults and families. This model of care has been found to be feasible and acceptable to adolescent patients (ages 12-17) at each level of service. TRRP includes 3 major steps: (1) in-hospital education, brief risk reduction session, and tracking patients' emotional recovery via an automated text-messaging system, (2) conducting a 30-day screen via telephone to identify patients who are good candidates for psychological treatment, and (3) providing referral to best-practice telehealth-based or in-person assessment and treatment. The investigators partnered with three accredited Level I and II pediatric trauma centers and propose a multi-site hybrid 1 effectiveness-implementation trial with 300 adolescent (ages 12-17) traumatic injury patients to: 1) assess the extent to which TRRP promotes improvement in quality of life and emotional recovery and 2) gather preliminary data on the potential for TRRP to be implemented in other Level I trauma centers. Directly in line with NICHD's Pediatric Trauma and Critical Illness Research and Training (PTCIB) Strategic Research and Training agenda, this study will provide valuable data on the efficacy, preliminary effectiveness and potential for implementation of an innovative, cost-effective, sustainable technology-enhanced intervention designed to address the unique needs of adolescent injury patients and mitigate short- and long-term impact of injury on mental health, quality of life, and overall well-being.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Injury, Technology, Posttraumatic Stress Disorder, Adolescents

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Trained interviewers blinded to condition will administer the 3-, 6-, and 12-month post-baseline assessments
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Trauma Resilience and Recovery Program (TRRP)
Arm Type
Experimental
Arm Description
Enrollment in TRRP which includes 3 major steps: (1) in-hospital education, brief risk reduction session, and tracking patients' emotional recovery via an automated text-messaging system, (2) conducting a 30-day screen via telephone to identify patients who are good candidates for psychological treatment, and (3) providing referral to formal mental health services, if needed.
Arm Title
Enhanced Usual Care
Arm Type
Active Comparator
Arm Description
Receive brief education about mental health after traumatic injury, educational materials about mental health recovery, and local referral information to assist treatment-seeking patients in seeking care
Intervention Type
Behavioral
Intervention Name(s)
TRRP
Intervention Description
Receive TRRP services
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Usual Care
Intervention Description
Participants will receive an educational flyer with service referrals
Primary Outcome Measure Information:
Title
The Child PTSD Symptom Scale, Caregiver/Child Version (CPSS)
Description
The CPSS is a 26-item measure to assess PTSD diagnostic criteria and severity in youth. Responses are assessed using a 4-point Likert scale and a cutoff score of 31 can be used for identifying a probable PTSD diagnosis in children.
Time Frame
3 months post-baseline assessment
Title
The Center for Epidemiological Studies Depression Scale (CES-DC)
Description
This is a 20-item measure of depression with strong psychometric properties. Responses are assessed using a 4-point Likert scale and a cutoff score of 15 is suggestive of depressive symptoms in children and adolescents.
Time Frame
3 months post-baseline assessment
Secondary Outcome Measure Information:
Title
Kessler 6
Description
This is a 6-item well-validated screening scale for nonspecific distress that demonstrates solid psychometric properties. Responses are assessed on a 5-point Likert scale and scores 13 or higher are suggestive of severe mental illness.
Time Frame
Baseline, 3, 6, and 12-month post-baseline assessment
Title
Peritraumatic Distress Inventory (PDI)
Description
This is a 13-item measure with strong psychometric properties used to assess distress at the time of injury. Responses are on a 4-point Likert scale and scores above 15 are suggestive of peritraumatic distress. This measure has been validated with child traumatic injury survivors.
Time Frame
Baseline
Title
Injured Trauma Survivor Screen (ITSS)
Description
This is a 9-item measure used to assess risk for development of posttraumatic stress symptoms following injury. Responses are in Yes/No format and a score of 2 on the PTSD questions suggest higher risk of developing PTSD and a score of 2 or more on the depression questions indicate higher risk for development of depression.
Time Frame
Baseline
Title
The Alcohol Use Disorders Identification Test-Consumption (AUDIT-C)
Description
This is a 3-item validated screen that identifies hazardous drinkers. The AUDIT-C is scored on a scale of 0-12 (scores of 0 reflect no alcohol use). In men, a score of 4 or more is considered positive; in women, a score of 3 or more is considered positive. Generally, the higher the AUDIT-C score, the more likely it is that the patient's drinking is affecting his/her health and safety.
Time Frame
Baseline, 3, 6, and 12-month post-baseline assessment
Title
Social Support Questionnaire, Short Form (SSQ6)
Description
This is a 6-item measure of social support that includes both availability and satisfaction with social support.
Time Frame
Baseline, 3, 6, and 12-month post-baseline assessment
Title
Pediatric Quality of Life Inventory, Short Form (Peds QL-SF15)
Description
This is a 15-item measure to assess health related QoL in youth with acute/chronic health conditions. Responses are assessed using a 5-point Likert scale with higher scores being indicative of higher health-related quality of life.
Time Frame
Baseline, 3, 6, and 12-month post-baseline assessment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: adolescent ages 12-17 admitted following traumatic injury scored significantly on the peritraumatic distress scale (PDI / ITSS) Exclusion Criteria: if the injury was self-inflicted injuries are so severe, they prevent participation (e.g., head or spinal cord injuries that prevent verbal communication)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tatiana M Davidson, PhD
Phone
843-792-1866
Email
davidst@musc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah German, BS
Phone
843-792-0979
Email
germansa@musc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tatiana Davidson, PhD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29466
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tatiana M Davidson, PhD
Phone
843-792-1866
Email
davidst@musc.edu
First Name & Middle Initial & Last Name & Degree
Ken Ruggiero, PhD
Email
ruggierk@musc.edu

12. IPD Sharing Statement

Learn more about this trial

Evaluation of Trauma Center-Based Intervention for Adolescent Traumatic Injury Survivors

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