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NCT04838977: ReSeT

Recovery After Stress Toolkit (RESET) Study

Completed NA Results posted Last updated 28 August 2025
What this trial tests

NA trial testing RESET in Post-Traumatic Stress Disorder in Children in 93 participants. Completed in 5 September 2024.

Timeline
23 July 2021
Primary endpoint
18 January 2024
5 September 2024

Quick facts

Lead sponsorUniversity of Utah
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment93
Start date23 July 2021
Primary completion18 January 2024
Estimated completion5 September 2024
Sites3 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Utah

Who can join

Adults 8 to 17, any sex, with Post-Traumatic Stress Disorder in Children or Post-Traumatic Stress Disorder in Adolescence. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Child PTSD Symptom Scale (CPSS) Primary · 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.

GroupValue95% CI
RESET10.4± 8.5
Control14± 9.5
Screen for Anxiety Related Emotional Disorders (SCARED) Secondary · 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

GroupValue95% CI
RESET12.6± 12.4
Control20.8± 14.7
Patient Reported Outcome Measurement Information System (PROMIS) Pediatric Depressive Symptoms Secondary · 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.

GroupValue95% CI
RESET42.9± 9.0
Control49.8± 10.9
Pediatric Quality of Life Inventory (PedsQL) Secondary · 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.

GroupValue95% CI
RESET71.4± 16.7
Control68.4± 17.2
Connor David Resilience Scale Secondary · 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).

GroupValue95% CI
RESET26.8± 12.1
Control21.4± 10.5
PROMIS Pediatric Anger Secondary · 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.

GroupValue95% CI
RESET43.6± 11.3
Control47.9± 11.9
PROMIS Pediatric Psychological Stress Experience Secondary · 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.

GroupValue95% CI
RESET47.1± 9.8
Control54.2± 10.8
PROMIS Pediatric Physical Stress Experience Secondary · 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.

GroupValue95% CI
RESET47.4± 9.6
Control53.3± 9.7
PROMIS Pediatric Anxiety Secondary · 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.

GroupValue95% CI
RESET42.7± 11.2
Control47.5± 11.1
PROMIS Pediatric Global Health Secondary · 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.

GroupValue95% CI
RESET51.0± 9.9
Control47± 10.7

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. 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.
    Keenan HT, Wade SL, Miron D, Presson AP, et al · · 2023 · cited 1× · PMID 38017574 · DOI 10.1186/s13063-023-07806-y
  2. Reducing Stress After Trauma in Physically Injured Children: A Randomized Clinical Trial.
    Ewing-Cobbs L, Wade SL, Murphy DM, McNally K, et al · · 2026 · PMID 42043806 · DOI 10.1001/jamapediatrics.2026.1143

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04838977.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing