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Using mHealth to Improve Emotional Recovery After Pediatric Injury

Primary Purpose

Trauma Injury, Child, Only, Posttraumatic Stress Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Caregivers' Aid to Accelerate Recovery after pediatric Emergencies (CAARE)
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trauma Injury

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • caregivers of children who experience pediatric traumatic injury
  • children younger than 12
  • caregivers older than age 18.

Exclusion Criteria:

  • caregiver's primary language is not English
  • self-afflicted injury
  • injuries resulting from caregiver abuse or neglect

Sites / Locations

  • Medical University of South CarolinaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Families receiving intervention

Arm Description

Outcomes

Primary Outcome Measures

Change in scores of caregiver self-report of psychological distress
Kessler Psychological Distress Scale (K6); higher scores indicate higher distress levels; Assesses feelings of nervousness, hopelessness, restlessness/fidgetiness, depression, worthlessness, and perceived effort burden; Each question asks patients to indicate how much of the time the child experienced the emotion/behavior during the past week by responding via a 5-point Likert scale (1=All to 5=None)
Change in scores in caregiver proxy-report of child emotional distress, ages 2-11
Pediatric Emotional Distress Scale (PEDS; caregiver proxy report ages 2-11); 21-item parent-report measure was designed to assess and screen for elevated symptomatology in children following exposure to a stressful and/or traumatic event; The measure yields scores on the following scales: 1) Anxious/Withdrawn, 2) Fearful, and 3) Acting Out.
Change in scores in child self-report and caregiver proxy-report of child Quality of Life (QOL)
PROMIS General Life Satisfaction (Caregiver QOL) consists of 10 items that assess general domains of health and functioning including overall physical health, mental health, social health, pain, fatigue, and overall perceived quality of life. The Pediatric Quality of Life Inventory (PEDSQL) consists of 23 items in that comprise four Generic Core Scales: Physical Functioning (8 items), Emotional Functioning (5 items), Social Functioning (5 items), and School Functioning (5 items). Items on the PedsQL are reverse scored and transformed to a 0-100 scale. Higher scores indicate better health related quality of life.
Change in scores in child self-report and caregiver proxy-report of child Posttraumatic Stress
The Child PTSD Symptom Scale, Child and Caregiver Versions (CPSS) includes 26 items assessing PTSD diagnostic criteria and severity in youth ages 6-17. Scores range from 0-51, with higher scores indicating higher symptoms of PTSD
Change in scores in child self-report (ages 6-11) of child depression; Caregiver self-report of caregiver depression
Patient Health Questionnaire (PHQ-8) will be used to assess symptoms of caregiver depression, with scores ranging from 0-24 and higher scores indicating higher depression symptoms. The Center for Epidemiological Studies Depression Scale for Children (CESD) is a 20-item measure assessing depression in children ages 6-17. Scores range from 0-60, with higher scores indicating higher symptoms of depression in children
Mean number of child missed daycare/school days due to pediatric traumatic injury
Caregiver will report on children's number of school and/or daycare days missed due to the injury
Mean number of child missed daycare/school days due to pediatric traumatic injury
Caregiver will report on children's number of school and/or daycare days missed due to the injury
Mean number of child missed daycare/school days due to pediatric traumatic injury
Caregiver will report on children's number of school and/or daycare days missed due to the injury
Change in caregiver health status
36-item Short Form Health Survey (SF-36) will be used to assess a generic indicator of caregivers' health status assessing physical health, role, social, and mental health function. Higher scores indicate more favorable health state, with scores ranging from 0-100.
Change in caregiver work and productivity status
A single questionnaire item asking caregivers whether they are working, laid off/looking for work, not working and not searching for employment, a student, a homemaker, volunteering, caretaking for another, retired, hospitalized or in a skilled nursing facility, in jail, disabled, or homeless.

Secondary Outcome Measures

Full Information

First Posted
October 1, 2020
Last Updated
May 22, 2023
Sponsor
Medical University of South Carolina
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT04579198
Brief Title
Using mHealth to Improve Emotional Recovery After Pediatric Injury
Official Title
A Scalable mHealth Resource to Facilitate Behavioral and Emotional Recovery After Pediatric Traumatic Injury
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
October 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
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
Nearly 300,000 U.S. children experience injuries that require them to be hospitalized this year. These children, and their caregivers, are at high risk for emotional and behavioral problems, as well as poor quality of life. Trauma centers in the US have good outcomes for survival and physical recovery, but they typically do not have programs to address the emotional and behavioral needs of families. The purpose of this project is to develop a service that achieves this and that can serve as a good model for trauma centers to use. This project will develop, evaluate, and test CAARE (Caregivers' Aid to Accelerate Recovery after pediatric Emergencies) to address the behavioral and emotional needs of caregivers and children.
Detailed Description
This project consists of three main study aims. The first aim is to finalize the CAARE model and research protocol in preparation for the open trial (Aim 2). To complete this study Aim, CAARE will first be refined guided by preliminary work led by the PI with caregivers after pediatric traumatic injury (PTI). Then, we will conduct usability testing and refine the mHealth components of CAARE with about 10 caregivers in preparation for the open trial (Aim 2). Finally, we will debug the research protocol via implementation of the full CAARE intervention with approximately 5 families prior to conducting the open trial. Aim 2, the open trial, is described in more detail in the Arms/Intervention section. Aim 3 is to assess CAARE implementation feasibility with families, trauma center leaders, and program managers. This will be conducted through qualitative interviews with (1) ~20 caregivers who participated in the open trial - diverse with respect to race, child age, and mental health status - to assess their reactions to CAARE; (2) ~15 pediatric trauma center directors and ~15 pediatric trauma program managers to identify perceived barriers and facilitators associated with implementing CAARE in pediatric trauma centers.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma Injury, Child, Only, Posttraumatic Stress Disorder, Parents

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Families receiving intervention
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Caregivers' Aid to Accelerate Recovery after pediatric Emergencies (CAARE)
Intervention Description
The intervention, CAARE (Caregivers' Aid to Accelerate Recovery after pediatric Emergencies), consists of four components: First, all caregivers of PTI patients (ages 0-11) will be given brief education in the hospital related to children's and caregivers' emotional recovery. Second, all families will receive an in-hospital risk-reduction session. These sessions will address avoidance and trauma triggers; scheduling of pleasurable activities; and coping strategies. Third, all caregivers will receive the CAARE app-based components before discharge. The app will engage caregivers for 30 days via an automated SMS system. MHealth components of care will reinforce risk-reduction strategies. Fourth, 30 days post-discharge, a brief behavioral health screen will be completed by caregiver and child to assess need for more intensive screening by a mental health provider. Caregivers/children reporting elevated symptom levels will receive a comprehensive screening and referral process.
Primary Outcome Measure Information:
Title
Change in scores of caregiver self-report of psychological distress
Description
Kessler Psychological Distress Scale (K6); higher scores indicate higher distress levels; Assesses feelings of nervousness, hopelessness, restlessness/fidgetiness, depression, worthlessness, and perceived effort burden; Each question asks patients to indicate how much of the time the child experienced the emotion/behavior during the past week by responding via a 5-point Likert scale (1=All to 5=None)
Time Frame
30 days; 60 days; and 90 days post-baseline
Title
Change in scores in caregiver proxy-report of child emotional distress, ages 2-11
Description
Pediatric Emotional Distress Scale (PEDS; caregiver proxy report ages 2-11); 21-item parent-report measure was designed to assess and screen for elevated symptomatology in children following exposure to a stressful and/or traumatic event; The measure yields scores on the following scales: 1) Anxious/Withdrawn, 2) Fearful, and 3) Acting Out.
Time Frame
baseline; 30 days; 60 days; and 90 days post-baseline
Title
Change in scores in child self-report and caregiver proxy-report of child Quality of Life (QOL)
Description
PROMIS General Life Satisfaction (Caregiver QOL) consists of 10 items that assess general domains of health and functioning including overall physical health, mental health, social health, pain, fatigue, and overall perceived quality of life. The Pediatric Quality of Life Inventory (PEDSQL) consists of 23 items in that comprise four Generic Core Scales: Physical Functioning (8 items), Emotional Functioning (5 items), Social Functioning (5 items), and School Functioning (5 items). Items on the PedsQL are reverse scored and transformed to a 0-100 scale. Higher scores indicate better health related quality of life.
Time Frame
baseline; 30 days; 60 days; and 90 days post-baseline
Title
Change in scores in child self-report and caregiver proxy-report of child Posttraumatic Stress
Description
The Child PTSD Symptom Scale, Child and Caregiver Versions (CPSS) includes 26 items assessing PTSD diagnostic criteria and severity in youth ages 6-17. Scores range from 0-51, with higher scores indicating higher symptoms of PTSD
Time Frame
baseline; 30 days; 60 days; and 90 days post-baseline
Title
Change in scores in child self-report (ages 6-11) of child depression; Caregiver self-report of caregiver depression
Description
Patient Health Questionnaire (PHQ-8) will be used to assess symptoms of caregiver depression, with scores ranging from 0-24 and higher scores indicating higher depression symptoms. The Center for Epidemiological Studies Depression Scale for Children (CESD) is a 20-item measure assessing depression in children ages 6-17. Scores range from 0-60, with higher scores indicating higher symptoms of depression in children
Time Frame
baseline; 30 days; 60 days; and 90 days post-baseline
Title
Mean number of child missed daycare/school days due to pediatric traumatic injury
Description
Caregiver will report on children's number of school and/or daycare days missed due to the injury
Time Frame
30 days post-baseline
Title
Mean number of child missed daycare/school days due to pediatric traumatic injury
Description
Caregiver will report on children's number of school and/or daycare days missed due to the injury
Time Frame
60 days post-baseline
Title
Mean number of child missed daycare/school days due to pediatric traumatic injury
Description
Caregiver will report on children's number of school and/or daycare days missed due to the injury
Time Frame
90 days post-baseline
Title
Change in caregiver health status
Description
36-item Short Form Health Survey (SF-36) will be used to assess a generic indicator of caregivers' health status assessing physical health, role, social, and mental health function. Higher scores indicate more favorable health state, with scores ranging from 0-100.
Time Frame
Baseline, 30 days; 60 days; and 90 days post-baseline
Title
Change in caregiver work and productivity status
Description
A single questionnaire item asking caregivers whether they are working, laid off/looking for work, not working and not searching for employment, a student, a homemaker, volunteering, caretaking for another, retired, hospitalized or in a skilled nursing facility, in jail, disabled, or homeless.
Time Frame
Baseline, 30 days; 60 days; and 90 days post-baseline

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: caregivers of children who experience pediatric traumatic injury children younger than 12 caregivers older than age 18. Exclusion Criteria: caregiver's primary language is not English self-afflicted injury injuries resulting from caregiver abuse or neglect
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Leigh Ridings, PhD
Phone
843-792-5146
Email
ridingle@musc.edu
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leigh Ridings, PhD
Phone
843-792-5146
Email
ridingle@musc.edu
First Name & Middle Initial & Last Name & Degree
Ebonie Powell, MA
Email
powelebo@musc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Using mHealth to Improve Emotional Recovery After Pediatric Injury

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