Recovery After Stress Toolkit (RESET) Study (ReSeT)

Pediatric Injury: Modules to Manage Medical Stress

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.

Study Overview

• Status: Completed
• Conditions: Post-Traumatic Stress Disorder in Children; Post-Traumatic Stress Disorder in Adolescence
• Intervention / Treatment: Behavioral: RESET

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 Type: Interventional
• Enrollment (Actual): 93
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45056
      • Cincinnati Children's Hospital
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas Health Sciences Center
  • Utah
    • Salt Lake City, Utah, United States, 84101
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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. We used the combined child report and parent report. The highest item score from either parent or child was summed.	10 weeks post-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. Range 0-82	10 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.	10-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.	10-weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	10-weeks
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.	10-weeks post-randomization
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.	10-weeks post-randomization
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.	10-weeks
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.	10-weeks
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.	10-weeks

Collaborators and Investigators

• Sponsor: University of Utah
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Heather T Keenan, MDCM, University of Utah

Publications and helpful links

General Publications

• Keenan HT, Wade SL, Miron D, Presson AP, Clark AE, Ewing-Cobbs L. Reducing Stress after Trauma (ReSeT): study protocol for a randomized, controlled trial of an online psychoeducational program and video therapy sessions for children hospitalized after trauma. Trials. 2023 Nov 28;24(1):766. doi: 10.1186/s13063-023-07806-y.

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2021
• Primary Completion (Actual): January 18, 2024
• Study Completion (Actual): September 5, 2024

Study Registration Dates

• First Submitted: March 30, 2021
• First Submitted That Met QC Criteria: April 8, 2021
• First Posted (Actual): April 9, 2021

Study Record Updates

• Last Update Posted (Estimated): August 28, 2025
• Last Update Submitted That Met QC Criteria: August 12, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: HD096350; R24HD096350 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual de-identified participant data underlying the trial will be made available 3 years after the last enrolled subject has completed all procedures to investigators who provide a methodologically sound proposal.
• IPD Sharing Time Frame: 36 months after last subject has completed all procedures. Data will be available for 36 months.
• IPD Sharing Access Criteria: Investigators who provide a methodologically sound proposal
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No