Clinical trial NCT04838977: Recovery After Stress Toolkit (RESET) Study
Official title: Pediatric Injury: Modules to Manage Medical Stress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-Traumatic Stress Disorder in Children
Post-Traumatic Stress Disorder in Adolescence
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2021-04-09
Enrollment: 93
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study comparing treatment to usual care.
Primary purpose: TREATMENT

Brief summary: This study evaluates the use of web-based educational modules combined with telehealth delivered therapy for children with post-traumatic stress symptoms (PTSS) after receiving hospital based medical attention for an injury. Half of the participants will received the online therapy and half of the participants will receive usual care.

Detailed description: As many as 30% of children develop post-traumatic stress symptoms after an injury. Post-traumatic stress symptoms can decrease children's quality of life. Psychological distress may emerge after the child is discharged from the hospital and may go unrecognized. Cognitive behavioral therapy and graduated exposures are standard treatments for PTSS.

Eligibility criteria: Inclusion Criteria:

* 8 years to 17 years at enrollment
* Treated for an injury in the ED or hospitalized
* Abbreviated Injury Scale (AIS) score 2 or greater
* Parent and child English speaking
* Broad band internet availability at home
* Residing with parent or legal guardian

Exclusion Criteria:

* Moderate or severe traumatic brain injury (GCS less than 13)
* Diagnosed with moderate or severe intellectual disability
* Pre-existing psychiatric disorder that required hospitalization
* Abuse or interpersonal injury as mechanism of injury
* Currently receiving psychotherapy
* Hospitalized for injury over 30 ays
* Death of a family member or friend at time of injury

Primary outcomes:
measure: Child PTSD Symptom Scale (CPSS)
timeFrame: 12 weeks poat-randomization
Secondary outcomes:
measure: Screen for Anxiety Related Emotional Disorders (SCARED)
timeFrame: 12 weeks post-randomization
measure: Patient Reported Outcome Measurement Information System (PROMIS) Pediatric Depressive Symptoms
timeFrame: 12-weeks post-randomization
measure: Pediatric Quality of Life Inventory (PedsQL)
timeFrame: 12-weeks
Other outcomes:
measure: Connor David Resilience Scale
timeFrame: 12-weeks
measure: PROMIS Pediatric Anger
timeFrame: 12-weeks post-randomization
measure: PROMIS Pediatric Psychological Stress Experience
timeFrame: 12-weeks post-randomization
measure: PROMIS Pediatric Physical Stress Experience
timeFrame: 12-weeks
measure: PROMIS Pediatric Anxiety
timeFrame: 12-weeks
measure: PROMIS Pediatric Global Health
timeFrame: 12-weeks
Locations:
city: Cincinnati
country: United States
facility: Cincinnati CHildren's Hospital
state: Ohio
city: Houston
country: United States
facility: University of Texas Health Sciences Center
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Heather T Keenan, MDCM
role: PRINCIPAL_INVESTIGATOR
References: