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Completed

NCT Number: NCT04838977

Recovery After Stress Toolkit (RESET) Study

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.

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Key information

Conditions

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

Age range

8 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cincinnati CHildren's Hospital, Cincinnati, Ohio, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RESET

Behavioral

Therapy

Primary outcomes

  1. Child PTSD Symptom Scale (CPSS)

    Time frame: 10 weeks post-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. We used the combined child report and parent report. The highest item score from either parent or child was summed.

Secondary outcomes

  1. Screen for Anxiety Related Emotional Disorders (SCARED)

    Time frame: 10 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. Range 0-82

  2. Patient Reported Outcome Measurement Information System (PROMIS) Pediatric Depressive Symptoms

    Time frame: 10-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.

  3. Pediatric Quality of Life Inventory (PedsQL)

    Time frame: 10-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.

Other outcomes

  1. Connor David Resilience Scale

    Time frame: 10-weeks

    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).

  2. PROMIS Pediatric Anger

    Time frame: 10-weeks post-randomization

    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.

  3. PROMIS Pediatric Psychological Stress Experience

    Time frame: 10-weeks post-randomization

    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.

  4. PROMIS Pediatric Physical Stress Experience

    Time frame: 10-weeks

    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.

  5. PROMIS Pediatric Anxiety

    Time frame: 10-weeks

    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.

  6. PROMIS Pediatric Global Health

    Time frame: 10-weeks

    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.

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

Pediatric Injury: Modules to Manage Medical Stress

Acronym: ReSeT

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Apr 9, 2021
Registry last updated
Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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