Status:
COMPLETED
Recovery After Stress Toolkit (ReSeT): Pilot Study
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Collaborating Sponsors:
University of Utah
The University of Texas Health Science Center, Houston
Conditions:
Post-traumatic Stress Disorder
Eligibility:
All Genders
8-17 years
Phase:
NA
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 effec...
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 inve...
Eligibility Criteria
Inclusion
- Ages of 8 to 17 years at time of enrollment
- Hospitalized for trauma at one of the following sites: PICU, ward or rapid treatment/observation unit (less than 23 hours stay)
- Both the parent and the child participating have the ability to read and speak English
- Have broadband internet availability at their home address
- Elevated post-traumatic stress symptoms (If the child exhibits clinically significant PTSS determined with the CPSS \[Foa et al., 2001\] with a score greater than or equal to 11 on the sum of the highest item by item score of parent/child report, they will be invited to participate in the pilot intervention. This methodology for using a joint score on the CPSS was informed by previous work indicating that both parents and children tend to underreport PTSS symptoms. Thus, implementing a multi-informant approach yields a more valid estimation of a child's psychopathology.)
Exclusion
- Has sustained a moderate or severe TBI, as defined by a Glasgow Coma Score of less than 13
- Has been diagnosed with moderate or severe intellectual disability , low functioning autism spectrum disorder, or a developmental disability (This will be determined by medical chart review and confirmed with parent report: Has the child ever been diagnosed with an intellectual or developmental disability? i.e., child must be able to talk; the rationale for this is that they may have difficulty mastering the course content)
- Has a pre-existing severe psychiatric disorder that required prior psychiatric hospitalization (e.g., bipolar disorder, schizophrenia)
- The mechanism of the injury was abuse or interpersonal violence
- They are currently receiving psychotherapy
- Has been hospitalized for their injury for over 30 days
- No attempt will be made to recruit caregivers while their child is unstable, e.g. vitals are abnormal, there are major complications, or death may be imminent. Children with multiple injuries are eligible to participate but their caregivers will not be approached until any interventions (surgery, casting, etc.) are completed.
Key Trial Info
Start Date :
November 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2021
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04830839
Start Date
November 1 2020
End Date
June 30 2021
Last Update
April 29 2025
Active Locations (1)
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1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229