| Sumario: | This randomized clinical trial investigates if the Reducing Stress After Trauma (ReSeT) brief online therapist-assisted health program is effective in reducing the severity of posttraumatic stress symptoms in children hospitalized for physical injury. Key Points: Question: Is the brief online therapist-assisted health program, Reducing Stress After Trauma (ReSeT), effective in reducing the severity of posttraumatic stress symptoms (PTSS) in children hospitalized for physical injury? Findings: In a randomized clinical trial of 93 children experiencing elevated PTSS 1 month after injury based on parent and/or child report, those randomized to ReSeT, an 8-session program informed by trauma-focused cognitive behavioral therapy involving interactive online learning modules and virtual therapist sessions, had significantly fewer PTSS 10 weeks after enrollment than the control group. Effects were maintained at a 6-month follow-up. Meaning: Findings show that the ReSeT program significantly reduced PTSS after pediatric injury. Importance: Posttraumatic stress symptoms (PTSS) affect nearly 50% of children experiencing physical trauma. PTSS often persists after physical recovery and is associated with reduced health-related quality of life. Objective: To evaluate efficacy of the online therapist-assisted, trauma-focused Reducing Stress After Trauma (ReSeT) program in reducing PTSS in children after hospitalization for physical injury. Design, Setting, and Participants: A 2-arm randomized clinical trial with 1:1 assignment to the ReSeT program or usual care (UC) was conducted between 2021 and 2024 at 4 sites with level 1 trauma centers. Injured children ages 8 to 17 years were recruited from inpatient and short-stay units. Exclusion criteria included moderate to severe traumatic brain injury, preexisting severe psychiatric problems, current psychotherapy, developmental disorders preventing participation, interpersonal violence, hospitalization for more than 30 days, and injury-related death of friend or family. Intervention: The ReSeT program has 8 online psychoeducational modules containing 3 to 4 short interactive videos that children completed independently. Modules are followed by an electronic health session with a therapist to practice cognitive behavioral skills and desensitization using trauma narrative techniques. Parents received optional psychoeducational resources. Main Outcomes and Measures: Generalized linear regression, controlling for baseline scores, was used to examine group differences on the Child Posttraumatic Stress Disorder Scale (CPSS) scores obtained 10 weeks (primary outcome) and 6 months (secondary outcome) after randomization. Results: A total of 638 of 722 children screened positive at 1 week, and 271 children and caregivers completed the CPSS at 4 weeks. The highest value from each respondent on each item was summed, and 130 children (48%) had CPSS scores of 11 or greater, indicating potential eligibility for enrollment. A total of 93 children (72%; mean [SD] age, 11.7 [2.4] years; 56 male [60.2%]) were included in the study; 47 were randomized to the ReSeT cohort and 46 were randomized to the UC cohort. Intention-to-treat analyses indicated significant reduction in combined CPSS scores in the ReSeT vs UC cohorts, −4.2 points (95% CI, −7.6 to −0.8 points) at 10 weeks, which was maintained at the 6-month follow-up, −5.5 points (95% CI, −8.9 to −2.1 points). Conclusions and Relevance: Findings of this randomized clinical trial show that the ReSeT program was an effective, brief, trauma-focused intervention for reducing PTSS after physical injury. It offers a potentially cost-effective, scalable program to address American College of Surgeons standards for psychological screening and treatment for children sustaining PTSS. Trial Registration: ClinicalTrials.gov Identifier: NCT04838977
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