Using mHealth to Improve Emotional Recovery After Pediatric Injury

NCT04579198 | Completed DMC

• 2 other identifiers: 00094279K23HD098325
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Trauma Injury; Child, Only; Posttraumatic Stress Disorder; Parents

Outcome Measures

Primary Outcomes (10)

• 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)

  30 days; 60 days; and 90 days post-baseline

• 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following exposure to a stressful and/or traumatic event; The measure yields scores on the following scales: 1) Anxious/Withdrawn, 2) Fearful, and 3) Acting Out.

  baseline; 30 days; 60 days; and 90 days post-baseline

• 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.

  baseline; 30 days; 60 days; and 90 days post-baseline

• 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

  baseline; 30 days; 60 days; and 90 days post-baseline

• 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

  baseline; 30 days; 60 days; and 90 days post-baseline

• 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

  30 days post-baseline

• 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

  60 days post-baseline

• 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

  90 days post-baseline

• 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.

  Baseline, 30 days; 60 days; and 90 days post-baseline

• 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.

  Baseline, 30 days; 60 days; and 90 days post-baseline

Study Arms (1)

Families receiving intervention

EXPERIMENTAL

Behavioral: Caregivers' Aid to Accelerate Recovery after pediatric Emergencies (CAARE)

Interventions

Caregivers' Aid to Accelerate Recovery after pediatric Emergencies (CAARE) BEHAVIORAL

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.

Families receiving intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of South Carolina: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Accidental Injuries; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Wounds and Injuries; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 1, 2020
• First Posted: October 8, 2020
• Study Start: March 1, 2022
• Primary Completion: October 10, 2024
• Study Completion: December 17, 2024
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)