Recovery After Stress Toolkit (RESET) Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pediatric Injury: Modules to Manage Medical Stress

Conditions
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Post-Traumatic Stress Disorder in Children, Post-Traumatic Stress Disorder in Adolescence

Intervention / Treatment
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* Behavioral: RESET


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Study comparing treatment to usual care.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RESET<br>Children will view 8 educational modules online and participate in 8 sessions with a therapist via telehealth. | Behavioral: RESET<br>* Therapy<br>|
| No Intervention: Control<br>Children will receive usual post-trauma care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child PTSD Symptom Scale (CPSS) | 17 items listing potential PTSD symptoms scored on a Likert scale of 0 to 3 with 0=Not at all and 3= 5 or more times a week. 7 additional yes/no questions ask if problems interfered with various activities. Higher score is worse. Range 0 to 80. | 12 weeks poat-randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Screen for Anxiety Related Emotional Disorders (SCARED) | 41-item survey with three point Likert scale responses (not sure, somewhat true, very true) that asks about common difficulties for children with anxiety. Higher scores indicate worse outcomes. The range are: Anxiety is 0-18; Panic Disorder 0-26; Separation Anxiety Disorder 0 - 16; Social Anxiety Disorder 0 to 8., | 12 weeks post-randomization | 
| Patient Reported Outcome Measurement Information System (PROMIS) Pediatric Depressive Symptoms | PROMIS pediatric item bank : 8 questions with a 5-point Likert response from Never to Almost Always. Higher scores means more depressive symptoms. T-score with mean = 50; Standard Deviation (SD)=10. | 12-weeks post-randomization | 
| Pediatric Quality of Life Inventory (PedsQL) | 15 question scale based on physical, emotional, social and school functioning answered on a 5-point Likert scale (never to almost always). Score is 0 - 100 with higher scores indicating better HRQoL. Parent proxy scale. | 12-weeks |