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Recovery After Stress Toolkit (ReSeT): Pilot Study (ReSeT)

Primary Purpose

Post-traumatic Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Recovery after Stress Toolkit (ReSeT)
Sponsored by
Children's Hospital Medical Center, Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-traumatic Stress Disorder focused on measuring post-traumatic stress, medical stress, e-health

Eligibility Criteria

8 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Ages of 8 to 17 years at time of enrollment
  • Hospitalized for trauma at one of the following sites: PICU, ward or rapid treatment/observation unit (less than 23 hours stay)
  • Both the parent and the child participating have the ability to read and speak English
  • Have broadband internet availability at their home address
  • Elevated post-traumatic stress symptoms (If the child exhibits clinically significant PTSS determined with the CPSS [Foa et al., 2001] with a score greater than or equal to 11 on the sum of the highest item by item score of parent/child report, they will be invited to participate in the pilot intervention. This methodology for using a joint score on the CPSS was informed by previous work indicating that both parents and children tend to underreport PTSS symptoms. Thus, implementing a multi-informant approach yields a more valid estimation of a child's psychopathology.)

Exclusion Criteria:

  • Has sustained a moderate or severe TBI, as defined by a Glasgow Coma Score of less than 13
  • Has been diagnosed with moderate or severe intellectual disability , low functioning autism spectrum disorder, or a developmental disability (This will be determined by medical chart review and confirmed with parent report: Has the child ever been diagnosed with an intellectual or developmental disability? i.e., child must be able to talk; the rationale for this is that they may have difficulty mastering the course content)
  • Has a pre-existing severe psychiatric disorder that required prior psychiatric hospitalization (e.g., bipolar disorder, schizophrenia)
  • The mechanism of the injury was abuse or interpersonal violence
  • They are currently receiving psychotherapy
  • Has been hospitalized for their injury for over 30 days
  • No attempt will be made to recruit caregivers while their child is unstable, e.g. vitals are abnormal, there are major complications, or death may be imminent. Children with multiple injuries are eligible to participate but their caregivers will not be approached until any interventions (surgery, casting, etc.) are completed.

Sites / Locations

  • Cincinnati Children's Hospital Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Recovery after Stress Toolkit (ReSeT)

Arm Description

ReSeT is comprised of interactive web-based psychoeducational modules that are developmentally tailored for school age children (8-17 years) for use with synchronous e-health therapy sessions with a trained therapist. Participants in the ReSeT treatment will complete 8 modules and therapy sessions. Parents will also have access to 4 modules During the study, children/youth will be asked to complete all eight sessions of the online treatment together with the therapist over an 8 -12 week time period (to allow for scheduling/cancellations). For younger children, parents will participate in the beginning and end of each session. Sessions will last approximately 30-60 minutes and will occur approximately every week for an anticipated 4-8 hour time commitment. Parents of older children will be permitted to review the content independently and participate in feedback sessions.

Outcomes

Primary Outcome Measures

Adherence
Adherence to the ReSeT intervention will be assessed by calculating the number of sessions participants complete out of the 8 proposed sessions.
Acceptability
The acceptability of the ReSeT intervention will be assessed with child and parent satisfaction surveys, and a qualitative interview with open-ended feedback about the program. The satisfaction surveys ask participants to rate their satisfaction with the program on a 4 point Likert scale (from "strongly disagree" to "strongly agree"), with higher scores indicative of greater satisfaction and acceptability.
Length of time to complete sessions
The feasibility of the ReSeT intervention will be assessed with the number of weeks that it takes participants to complete the 8 sessions of the intervention. The intervention was designed to take place over a 12 week period, with sessions occurring weekly.

Secondary Outcome Measures

Child post-traumatic stress symptoms (PTSS)
The Child Post-Traumatic Stress Disorder Scale (CPSS; Foa et al, 2001) is a validated child report and parent proxy measure of PTSS. The measure is comprised of 24-items. The CPSS includes 17 questions mapping on to DSM-IV symptoms of PTSD rated on a 4-point scale that indicates how frequently each symptom occurs (0 = not at all, 1 = once a week or less/once in a while, 2 = 2 to 4 times a week/half the time, 3 = 5 or more times a week/almost always). In addition, the CPSS includes seven questions regarding functional impairment. These questions are scored dichotomously as absent (0) or present (1). Scores range from 0 - 7, with higher scores indicating greater functional impairment.
Child anxiety symptoms
The Screen Child Anxiety and Related Emotional Disorders (SCARED; Birmaher et al., 1999) is a widely used questionnaire that screens for anxiety and emotional disorders in children. The child self-report version will be used in this study, which consists of 41 items rated on a 3-point Likert scale ( 0 = not true or hardly ever true, 1 = somewhat true or sometimes true, 2 = very true or often true). This measures yields raw scores for anxiety disorder, panic disorder, generalized anxiety disorder, separation anxiety, social anxiety disorder, and significant school avoidance.
Child quality of life
The Pediatric Quality of Life Inventory (PedsQL 4.0; Varni et al., 2001) is a well-validated parent- report measure consisting of 15 items that takes less than 5 minutes to complete. The PedsQL evaluates health-related quality of life by assessing the dimensions of physical, emotional, social, and cognitive functioning in children from infancy to 18 years of life age. The total quality of life scale score will be utilized.
Child depressive symptoms
The Patient Reported Outcomes Measurement Information System (PROMIS; Varni et al., 2014) is a National Institutes of Health (NIH) initiative created to advance assessment of patient-reported outcomes. The PROMIS Pediatric Cooperative Group has developed pediatric self-report item banks across five generic health domains that have been further delineated into eight latent structures. The current study will use both the pediatric self-report and parent proxy short forms for the anger, anxiety, depression, psychological stress, and physical stress scales which are each eight items and the global health scale which is seven items. Additionally, the eight item sleep disturbance questionnaire will be completed by parents.

Full Information

First Posted
April 1, 2021
Last Updated
December 9, 2021
Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
University of Utah, The University of Texas Health Science Center, Houston, Tulane University
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1. Study Identification

Unique Protocol Identification Number
NCT04830839
Brief Title
Recovery After Stress Toolkit (ReSeT): Pilot Study
Acronym
ReSeT
Official Title
Online Modules to Help Children Manage Medical Stress After an Injury: Recovery After Stress Toolkit (ReSeT) Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
University of Utah, The University of Texas Health Science Center, Houston, Tulane University

4. Oversight

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

5. Study Description

Brief Summary
Experiencing an accident and staying in the hospital can be scary and traumatic for children. The goal of this project is to develop an online resource to help children and their parents develop effective coping skills to manage their stress. Children ages 8-17 who exhibit signs of posttraumatic stress will view 8 online modules and attend weekly videoconferencing sessions with a therapist. Parents will have 4 modules to assist them in supporting their child after the injury.
Detailed Description
The overarching goal of this project is to provide a research and treatment resource for the management of psychological distress in children who have been hospitalized for a physical trauma. The investigators will pilot an innovative, brief e-health approach to treatment of PTSS designed to be delivered through the trauma system. The investigators will create interactive web-based psychoeducational modules that are developmentally tailored for school age children (8 to 17 years) for use with synchronous e-health therapy sessions with a trained therapist. Companion modules for parents will help parents to understand and respond to their child's PTSS. The investigators will perform a single-arm pilot trial of a brief e-health approach to treatment of PTSS (i.e., Recovery after Stress Toolkit; ReSeT). ( delete with usual care.)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-traumatic Stress Disorder
Keywords
post-traumatic stress, medical stress, e-health

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is a single group design as all eligible participants will be offered the 8 session Recovery after Stress Toolkit (ReSeT) program, including 8 self-guided child modules and 4 parent modules, as well as 8 parallel videoconferencing sessions with a therapist.
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Recovery after Stress Toolkit (ReSeT)
Arm Type
Experimental
Arm Description
ReSeT is comprised of interactive web-based psychoeducational modules that are developmentally tailored for school age children (8-17 years) for use with synchronous e-health therapy sessions with a trained therapist. Participants in the ReSeT treatment will complete 8 modules and therapy sessions. Parents will also have access to 4 modules During the study, children/youth will be asked to complete all eight sessions of the online treatment together with the therapist over an 8 -12 week time period (to allow for scheduling/cancellations). For younger children, parents will participate in the beginning and end of each session. Sessions will last approximately 30-60 minutes and will occur approximately every week for an anticipated 4-8 hour time commitment. Parents of older children will be permitted to review the content independently and participate in feedback sessions.
Intervention Type
Behavioral
Intervention Name(s)
Recovery after Stress Toolkit (ReSeT)
Intervention Description
ReSeT involves online modules with parallel videoconferencing sessions. ReSeT integrates two evidence-based treatment methods: cognitive behavioral therapy coping skills (coping CBT) and direct exposure to trauma reminders through a trauma narrative.
Primary Outcome Measure Information:
Title
Adherence
Description
Adherence to the ReSeT intervention will be assessed by calculating the number of sessions participants complete out of the 8 proposed sessions.
Time Frame
Feasibility will be assessed at 12 weeks post-enrollment.
Title
Acceptability
Description
The acceptability of the ReSeT intervention will be assessed with child and parent satisfaction surveys, and a qualitative interview with open-ended feedback about the program. The satisfaction surveys ask participants to rate their satisfaction with the program on a 4 point Likert scale (from "strongly disagree" to "strongly agree"), with higher scores indicative of greater satisfaction and acceptability.
Time Frame
Acceptability will be assessed at 12 weeks post-enrollment.
Title
Length of time to complete sessions
Description
The feasibility of the ReSeT intervention will be assessed with the number of weeks that it takes participants to complete the 8 sessions of the intervention. The intervention was designed to take place over a 12 week period, with sessions occurring weekly.
Time Frame
This outcome will be assessed at the end of the 8 sessions of the intervention.
Secondary Outcome Measure Information:
Title
Child post-traumatic stress symptoms (PTSS)
Description
The Child Post-Traumatic Stress Disorder Scale (CPSS; Foa et al, 2001) is a validated child report and parent proxy measure of PTSS. The measure is comprised of 24-items. The CPSS includes 17 questions mapping on to DSM-IV symptoms of PTSD rated on a 4-point scale that indicates how frequently each symptom occurs (0 = not at all, 1 = once a week or less/once in a while, 2 = 2 to 4 times a week/half the time, 3 = 5 or more times a week/almost always). In addition, the CPSS includes seven questions regarding functional impairment. These questions are scored dichotomously as absent (0) or present (1). Scores range from 0 - 7, with higher scores indicating greater functional impairment.
Time Frame
Child PTSS from pre-intervention (within 6 months of the injury discharge) will be compared to the child's PTSS post-intervention, at 12 weeks post-enrollment or until the child has finished treatment.
Title
Child anxiety symptoms
Description
The Screen Child Anxiety and Related Emotional Disorders (SCARED; Birmaher et al., 1999) is a widely used questionnaire that screens for anxiety and emotional disorders in children. The child self-report version will be used in this study, which consists of 41 items rated on a 3-point Likert scale ( 0 = not true or hardly ever true, 1 = somewhat true or sometimes true, 2 = very true or often true). This measures yields raw scores for anxiety disorder, panic disorder, generalized anxiety disorder, separation anxiety, social anxiety disorder, and significant school avoidance.
Time Frame
Child anxiety from pre-intervention (within 6 months of the injury discharge) will be compared to child anxiety post-intervention, at 12 weeks post-enrollment or until the child has finished treatment.
Title
Child quality of life
Description
The Pediatric Quality of Life Inventory (PedsQL 4.0; Varni et al., 2001) is a well-validated parent- report measure consisting of 15 items that takes less than 5 minutes to complete. The PedsQL evaluates health-related quality of life by assessing the dimensions of physical, emotional, social, and cognitive functioning in children from infancy to 18 years of life age. The total quality of life scale score will be utilized.
Time Frame
Child quality of life from pre-intervention (within 6 months of the injury discharge) will be compared to child quality of life post-intervention, at 12 weeks post-enrollment or until the child has finished treatment.
Title
Child depressive symptoms
Description
The Patient Reported Outcomes Measurement Information System (PROMIS; Varni et al., 2014) is a National Institutes of Health (NIH) initiative created to advance assessment of patient-reported outcomes. The PROMIS Pediatric Cooperative Group has developed pediatric self-report item banks across five generic health domains that have been further delineated into eight latent structures. The current study will use both the pediatric self-report and parent proxy short forms for the anger, anxiety, depression, psychological stress, and physical stress scales which are each eight items and the global health scale which is seven items. Additionally, the eight item sleep disturbance questionnaire will be completed by parents.
Time Frame
Child depressive symptoms from pre-intervention (within 6 months of the injury discharge) will be compared to child depressive symptoms post-intervention, at 12 weeks post-enrollment or until the child has finished treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ages of 8 to 17 years at time of enrollment Hospitalized for trauma at one of the following sites: PICU, ward or rapid treatment/observation unit (less than 23 hours stay) Both the parent and the child participating have the ability to read and speak English Have broadband internet availability at their home address Elevated post-traumatic stress symptoms (If the child exhibits clinically significant PTSS determined with the CPSS [Foa et al., 2001] with a score greater than or equal to 11 on the sum of the highest item by item score of parent/child report, they will be invited to participate in the pilot intervention. This methodology for using a joint score on the CPSS was informed by previous work indicating that both parents and children tend to underreport PTSS symptoms. Thus, implementing a multi-informant approach yields a more valid estimation of a child's psychopathology.) Exclusion Criteria: Has sustained a moderate or severe TBI, as defined by a Glasgow Coma Score of less than 13 Has been diagnosed with moderate or severe intellectual disability , low functioning autism spectrum disorder, or a developmental disability (This will be determined by medical chart review and confirmed with parent report: Has the child ever been diagnosed with an intellectual or developmental disability? i.e., child must be able to talk; the rationale for this is that they may have difficulty mastering the course content) Has a pre-existing severe psychiatric disorder that required prior psychiatric hospitalization (e.g., bipolar disorder, schizophrenia) The mechanism of the injury was abuse or interpersonal violence They are currently receiving psychotherapy Has been hospitalized for their injury for over 30 days No attempt will be made to recruit caregivers while their child is unstable, e.g. vitals are abnormal, there are major complications, or death may be imminent. Children with multiple injuries are eligible to participate but their caregivers will not be approached until any interventions (surgery, casting, etc.) are completed.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shari Wade, PhD
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The pilot is only anticipated to have 12-16 participants and thus,data may be identifiable. The investigators have decided to withhold the sharing individual participant data.
Citations:
PubMed Identifier
11501254
Citation
Foa EB, Johnson KM, Feeny NC, Treadwell KR. The child PTSD Symptom Scale: a preliminary examination of its psychometric properties. J Clin Child Psychol. 2001 Sep;30(3):376-84. doi: 10.1207/S15374424JCCP3003_9.
Results Reference
background
PubMed Identifier
10517055
Citation
Birmaher B, Brent DA, Chiappetta L, Bridge J, Monga S, Baugher M. Psychometric properties of the Screen for Child Anxiety Related Emotional Disorders (SCARED): a replication study. J Am Acad Child Adolesc Psychiatry. 1999 Oct;38(10):1230-6. doi: 10.1097/00004583-199910000-00011.
Results Reference
background
PubMed Identifier
24085345
Citation
Varni JW, Magnus B, Stucky BD, Liu Y, Quinn H, Thissen D, Gross HE, Huang IC, DeWalt DA. Psychometric properties of the PROMIS (R) pediatric scales: precision, stability, and comparison of different scoring and administration options. Qual Life Res. 2014 May;23(4):1233-43. doi: 10.1007/s11136-013-0544-0. Epub 2013 Oct 2.
Results Reference
background
PubMed Identifier
11468499
Citation
Varni JW, Seid M, Kurtin PS. PedsQL 4.0: reliability and validity of the Pediatric Quality of Life Inventory version 4.0 generic core scales in healthy and patient populations. Med Care. 2001 Aug;39(8):800-12. doi: 10.1097/00005650-200108000-00006.
Results Reference
background

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Recovery After Stress Toolkit (ReSeT): Pilot Study

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