Ignite Creation Date:
2024-05-06 @ 4:00 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04830839
Status:
COMPLETED
Last Update Posted:
2021-12-10
First Post:
2021-04-01
Brief Title:
Recovery After Stress Toolkit ReSeT Pilot Study
Sponsor:
Childrens Hospital Medical Center Cincinnati
Organization:
Childrens Hospital Medical Center Cincinnati
Study Overview
Official Title:
Online Modules to Help Children Manage Medical Stress After an Injury Recovery After Stress Toolkit ReSeT Pilot Study
Status:
COMPLETED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ReSeT
Brief Summary:
Experiencing an accident and staying in the hospital can be scary and traumatic for children The goal of this project is to develop an online resource to help children and their parents develop effective coping skills to manage their stress Children ages 8-17 who exhibit signs of posttraumatic stress will view 8 online modules and attend weekly videoconferencing sessions with a therapist Parents will have 4 modules to assist them in supporting their child after the injury
Detailed Description:
The overarching goal of this project is to provide a research and treatment resource for the management of psychological distress in children who have been hospitalized for a physical trauma The investigators will pilot an innovative brief e-health approach to treatment of PTSS designed to be delivered through the trauma system The investigators will create interactive web-based psychoeducational modules that are developmentally tailored for school age children 8 to 17 years for use with synchronous e-health therapy sessions with a trained therapist Companion modules for parents will help parents to understand and respond to their childs PTSS The investigators will perform a single-arm pilot trial of a brief e-health approach to treatment of PTSS ie Recovery after Stress Toolkit ReSeT delete with usual care
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None