Recovery After Stress Toolkit (RESET) Study

Not Applicable

Completed

• Conditions: Post-Traumatic Stress Disorder in Adolescence; Post-Traumatic Stress Disorder in Children
• Interventions: Behavioral: RESET

• Registration Number: NCT04838977
• Lead Sponsor: University of Utah

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.

Study Timeline

• Study First Submitted: 2021-03-30
• Study First Submitted QC: 2021-04-08
• Study First Posted: 2021-04-09
• Study Start: 2021-07-23
• Primary Completion: 2024-01-18
• Study Completion: 2024-01-18
• Status Verified: 2024-04
• Last Update Submitted: 2025-04-16
• Last Update Posted: 2025-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RESET	RESET	Children will view 8 educational modules online and participate in 8 sessions with a therapist via telehealth.

Primary Outcome Measures

Name	Time	Method
Child PTSD Symptom Scale (CPSS)	12 weeks poat-randomization	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.

Secondary Outcome Measures

Name	Time	Method
Patient Reported Outcome Measurement Information System (PROMIS) Pediatric Depressive Symptoms	12-weeks post-randomization	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.
Screen for Anxiety Related Emotional Disorders (SCARED)	12 weeks post-randomization	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.,
Pediatric Quality of Life Inventory (PedsQL)	12-weeks	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.

Trial Locations

Locations (3)

University of Texas Health Sciences Center; 🇺🇸 Houston, Texas, United States

University of Utah; 🇺🇸 Salt Lake City, Utah, United States

Cincinnati CHildren's Hospital; 🇺🇸 Cincinnati, Ohio, United States