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Using mHealth to Improve Emotional Recovery After Pediatric Injury

Medical University of South Carolina (MUSC) logo

Medical University of South Carolina (MUSC)

Status

Completed

Conditions

Posttraumatic Stress Disorder
Child, Only
Trauma Injury
Parents

Treatments

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

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT04579198
00094279
K23HD098325 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

54 patients

Sex

All

Volunteers

Accepts 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

54 participants in 1 patient group

Families receiving intervention
Experimental group
Treatment:
Behavioral: Caregivers' Aid to Accelerate Recovery after pediatric Emergencies (CAARE)

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Leigh Ridings, PhD

Data sourced from clinicaltrials.gov

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