Recovery After Stress Toolkit (RESET) Study

Post-Traumatic Stress Disorder in Children Clinical Trial

— ReSeT  

Official title:

Pediatric Injury: Modules to Manage Medical Stress

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04838977
• Other study ID #: HD096350
• Secondary ID: R24HD096350
• Status: Completed
• Phase: N/A
• Start date: July 23, 2021
• Est. completion date: January 18, 2024

Study information

• Verified date: April 2024
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: January 18, 2024
• Est. primary completion date: January 18, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Post-Traumatic Stress Disorder in Adolescence
• Post-Traumatic Stress Disorder in Children
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• RESET
Therapy

Locations

Country	Name	City	State
United States	Cincinnati CHildren's Hospital	Cincinnati	Ohio
United States	University of Texas Health Sciences Center	Houston	Texas
United States	University of Utah	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Connor David Resilience Scale	10-item scale with LIkert response from 0 - not true to 4=true nearly all of the time. Range is 0 to 40 with higher scores indicating more resilience (better).	12-weeks
Other	PROMIS Pediatric Anger	5 question PROMIS measure answered with a 5-point Likert scale. A higher score indicates more anger (worse). T-score with mean = 50; SD = 10.	12-weeks post-randomization
Other	PROMIS Pediatric Psychological Stress Experience	8-question PROMIS measure answered with a 5-point Likert scale. A higher score is more stress (worse). T-score with mean 50; SD 10.	12-weeks post-randomization
Other	PROMIS Pediatric Physical Stress Experience	8-question PROMIS measure answered on a 5-point Likert scale. A higher score is more physical stress (worse). T-score with mean 50; SD 10.	12-weeks
Other	PROMIS Pediatric Anxiety	8-question PROMIS measure answered on a 5-point LIkert scale. A higher score is more anxiety (worse). T-score with mean 50; SD 10.	12-weeks
Other	PROMIS Pediatric Global Health	Seven questions about global health with 5-point Likert response from excellent to poor. A higher score is more poor health (worse). T-score with mean 50; SD 10.	12-weeks
Primary	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	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
Secondary	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
Secondary	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