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Recovery After Stress Toolkit (RESET) Study (ReSeT)

Primary Purpose

Post-Traumatic Stress Disorder in Children, Post-Traumatic Stress Disorder in Adolescence

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RESET
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-Traumatic Stress Disorder in Children

Eligibility Criteria

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

Inclusion Criteria:

  • 8 years to 17 years at enrollment
  • Treated for an injury in the ED or hospitalized
  • Abbreviated Injury Scale (AIS) score 2 or greater
  • Parent and child English speaking
  • Broad band internet availability at home
  • Residing with parent or legal guardian

Exclusion Criteria:

  • Moderate or severe traumatic brain injury (GCS less than 13)
  • Diagnosed with moderate or severe intellectual disability
  • Pre-existing psychiatric disorder that required hospitalization
  • Abuse or interpersonal injury as mechanism of injury
  • Currently receiving psychotherapy
  • Hospitalized for injury over 30 ays
  • Death of a family member or friend at time of injury

Sites / Locations

  • Cincinnati CHildren's HospitalRecruiting
  • University of Texas Health Sciences CenterRecruiting
  • University of UtahRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

RESET

Control

Arm Description

Children will view 8 educational modules online and participate in 8 sessions with a therapist via telehealth.

Children will receive usual post-trauma care.

Outcomes

Primary Outcome Measures

Child PTSD Symptom Scale (CPSS)
17 items listing potential PTSD symptoms scored on a Likert scale of 0 to 3 with 0=Not at all and 3= 5 or more times a week. 7 additional yes/no questions ask if problems interfered with various activities. Higher score is worse. Range 0 to 80.

Secondary Outcome Measures

Screen for Anxiety Related Emotional Disorders (SCARED)
41-item survey with three point Likert scale responses (not sure, somewhat true, very true) that asks about common difficulties for children with anxiety. Higher scores indicate worse outcomes. The range are: Anxiety is 0-18; Panic Disorder 0-26; Separation Anxiety Disorder 0 - 16; Social Anxiety Disorder 0 to 8.,
Patient Reported Outcome Measurement Information System (PROMIS) Pediatric Depressive Symptoms
PROMIS pediatric item bank : 8 questions with a 5-point Likert response from Never to Almost Always. Higher scores means more depressive symptoms. T-score with mean = 50; Standard Deviation (SD)=10.
Pediatric Quality of Life Inventory (PedsQL)
15 question scale based on physical, emotional, social and school functioning answered on a 5-point Likert scale (never to almost always). Score is 0 - 100 with higher scores indicating better HRQoL. Parent proxy scale.

Full Information

First Posted
March 30, 2021
Last Updated
April 4, 2023
Sponsor
University of Utah
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT04838977
Brief Title
Recovery After Stress Toolkit (RESET) Study
Acronym
ReSeT
Official Title
Pediatric Injury: Modules to Manage Medical Stress
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 23, 2021 (Actual)
Primary Completion Date
October 15, 2023 (Anticipated)
Study Completion Date
April 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Utah
Collaborators
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
This study evaluates the use of web-based educational modules combined with telehealth delivered therapy for children with post-traumatic stress symptoms (PTSS) after receiving hospital based medical attention for an injury. Half of the participants will received the online therapy and half of the participants will receive usual care.
Detailed Description
As many as 30% of children develop post-traumatic stress symptoms after an injury. Post-traumatic stress symptoms can decrease children's quality of life. Psychological distress may emerge after the child is discharged from the hospital and may go unrecognized. Cognitive behavioral therapy and graduated exposures are standard treatments for PTSS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Traumatic Stress Disorder in Children, Post-Traumatic Stress Disorder in Adolescence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Study comparing treatment to usual care.
Masking
Investigator
Masking Description
Investigators will not be aware of study assignment.
Allocation
Randomized
Enrollment
106 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RESET
Arm Type
Experimental
Arm Description
Children will view 8 educational modules online and participate in 8 sessions with a therapist via telehealth.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Children will receive usual post-trauma care.
Intervention Type
Behavioral
Intervention Name(s)
RESET
Intervention Description
Therapy
Primary Outcome Measure Information:
Title
Child PTSD Symptom Scale (CPSS)
Description
17 items listing potential PTSD symptoms scored on a Likert scale of 0 to 3 with 0=Not at all and 3= 5 or more times a week. 7 additional yes/no questions ask if problems interfered with various activities. Higher score is worse. Range 0 to 80.
Time Frame
12 weeks poat-randomization
Secondary Outcome Measure Information:
Title
Screen for Anxiety Related Emotional Disorders (SCARED)
Description
41-item survey with three point Likert scale responses (not sure, somewhat true, very true) that asks about common difficulties for children with anxiety. Higher scores indicate worse outcomes. The range are: Anxiety is 0-18; Panic Disorder 0-26; Separation Anxiety Disorder 0 - 16; Social Anxiety Disorder 0 to 8.,
Time Frame
12 weeks post-randomization
Title
Patient Reported Outcome Measurement Information System (PROMIS) Pediatric Depressive Symptoms
Description
PROMIS pediatric item bank : 8 questions with a 5-point Likert response from Never to Almost Always. Higher scores means more depressive symptoms. T-score with mean = 50; Standard Deviation (SD)=10.
Time Frame
12-weeks post-randomization
Title
Pediatric Quality of Life Inventory (PedsQL)
Description
15 question scale based on physical, emotional, social and school functioning answered on a 5-point Likert scale (never to almost always). Score is 0 - 100 with higher scores indicating better HRQoL. Parent proxy scale.
Time Frame
12-weeks
Other Pre-specified Outcome Measures:
Title
Connor David Resilience Scale
Description
10-item scale with LIkert response from 0 - not true to 4=true nearly all of the time. Range is 0 to 40 with higher scores indicating more resilience (better).
Time Frame
12-weeks
Title
PROMIS Pediatric Anger
Description
5 question PROMIS measure answered with a 5-point Likert scale. A higher score indicates more anger (worse). T-score with mean = 50; SD = 10.
Time Frame
12-weeks post-randomization
Title
PROMIS Pediatric Psychological Stress Experience
Description
8-question PROMIS measure answered with a 5-point Likert scale. A higher score is more stress (worse). T-score with mean 50; SD 10.
Time Frame
12-weeks post-randomization
Title
PROMIS Pediatric Physical Stress Experience
Description
8-question PROMIS measure answered on a 5-point Likert scale. A higher score is more physical stress (worse). T-score with mean 50; SD 10.
Time Frame
12-weeks
Title
PROMIS Pediatric Anxiety
Description
8-question PROMIS measure answered on a 5-point LIkert scale. A higher score is more anxiety (worse). T-score with mean 50; SD 10.
Time Frame
12-weeks
Title
PROMIS Pediatric Global Health
Description
Seven questions about global health with 5-point Likert response from excellent to poor. A higher score is more poor health (worse). T-score with mean 50; SD 10.
Time Frame
12-weeks

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: 8 years to 17 years at enrollment Treated for an injury in the ED or hospitalized Abbreviated Injury Scale (AIS) score 2 or greater Parent and child English speaking Broad band internet availability at home Residing with parent or legal guardian Exclusion Criteria: Moderate or severe traumatic brain injury (GCS less than 13) Diagnosed with moderate or severe intellectual disability Pre-existing psychiatric disorder that required hospitalization Abuse or interpersonal injury as mechanism of injury Currently receiving psychotherapy Hospitalized for injury over 30 ays Death of a family member or friend at time of injury
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heather T Keenan, MDCM
Phone
801.587.7611
Email
heather.keenan@hsc.utah.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heather T Keenan, MDCM
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati CHildren's Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45056
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shari Wade, PHD
Email
shari.wade@cchmc.org
Facility Name
University of Texas Health Sciences Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linda Ewing-Cobbs, PHD
Phone
713-500-3878
Email
Linda.Ewing-Cobbs@uth.tmc.edu
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heather T Keenan, MDCM
Phone
801-587-7611
Email
heather.keenan@hsc.utah.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual de-identified participant data underlying the trial will be made available 3 years after the last enrolled subject has completed all procedures to investigators who provide a methodologically sound proposal.
IPD Sharing Time Frame
36 months after last subject has completed all procedures. Data will be available for 36 months.
IPD Sharing Access Criteria
Investigators who provide a methodologically sound proposal

Learn more about this trial

Recovery After Stress Toolkit (RESET) Study

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