Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Child, Only
  • Parents
  • Posttraumatic Stress Disorder
  • Trauma Injury
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Younger than 125 years
Gender
Both males and females

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 inj...

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.

Tracking Information

NCT #
NCT04579198
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Not Provided