Clinical trial NCT04579198: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Trauma Injury
Child, Only
Posttraumatic Stress Disorder
Parents
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2020-10-08
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in scores of caregiver self-report of psychological distress
timeFrame: 30 days; 60 days; and 90 days post-baseline
measure: Change in scores in caregiver proxy-report of child emotional distress, ages 2-11
timeFrame: baseline; 30 days; 60 days; and 90 days post-baseline
measure: Change in scores in child self-report and caregiver proxy-report of child Quality of Life (QOL)
timeFrame: baseline; 30 days; 60 days; and 90 days post-baseline
measure: Change in scores in child self-report and caregiver proxy-report of child Posttraumatic Stress
timeFrame: baseline; 30 days; 60 days; and 90 days post-baseline
measure: Change in scores in child self-report (ages 6-11) of child depression; Caregiver self-report of caregiver depression
timeFrame: baseline; 30 days; 60 days; and 90 days post-baseline
measure: Mean number of child missed daycare/school days due to pediatric traumatic injury
timeFrame: 30 days post-baseline
measure: Mean number of child missed daycare/school days due to pediatric traumatic injury
timeFrame: 60 days post-baseline
measure: Mean number of child missed daycare/school days due to pediatric traumatic injury
timeFrame: 90 days post-baseline
measure: Change in caregiver health status
timeFrame: Baseline, 30 days; 60 days; and 90 days post-baseline
measure: Change in caregiver work and productivity status
timeFrame: Baseline, 30 days; 60 days; and 90 days post-baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References: