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创伤后应激减少(ReSeT):一项在线心理教育计划和视频治疗课程对创伤后住院儿童的随机对照试验研究方案。

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.

机构信息

Department of Pediatrics, University of Utah School of Medicine, 295 Chipeta Way, Salt Lake City, UT, 84108, USA.

Cincinnati Children's Hospital Medical Center Division of Pediatric Rehabilitation, Department of Pediatrics, University of Cincinnati College of Medicine, 3333 Burnet Avenue, Cincinnati, OH, 45229-3039, USA.

出版信息

Trials. 2023 Nov 28;24(1):766. doi: 10.1186/s13063-023-07806-y.


DOI:10.1186/s13063-023-07806-y
PMID:38017574
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10683223/
Abstract

BACKGROUND: Post-traumatic stress symptoms develop in a quarter to half of injured children affecting their longer-term psychologic and physical health. Evidence-based care exists for post-traumatic stress; however, it is not readily available in some communities. We have developed an eHealth program consisting of online, interactive educational modules and telehealth therapist support based in trauma-focused cognitive behavioral therapy, the Reducing Stress after Trauma (ReSeT) program. We hypothesize that children with post-traumatic stress who participate in ReSeT will have fewer symptoms compared to the usual care control group. METHODS: This is a randomized controlled trial to test the effectiveness of the ReSeT intervention in reducing symptoms of post-traumatic stress compared to a usual care control group. One hundred and six children ages 8-17 years, who were admitted to hospital following an injury, with post-traumatic stress symptoms at 4 weeks post-injury, will be recruited and randomized from the four participating trauma centers. The outcomes compared across groups will be post-traumatic stress symptoms at 10 weeks (primary outcome) controlling for baseline symptoms and at 6 months post-randomization (secondary outcome). DISCUSSION: ReSeT is an evidence-based program designed to reduce post-traumatic stress symptoms among injured children using an eHealth platform. Currently, the American College of Surgeons standards suggest that trauma programs identify and treat patients at high risk for mental health needs in the trauma system. If effectiveness is demonstrated, ReSeT could help increase access to evidence-based care for children with post-traumatic stress within the trauma system. TRIAL REGISTRATION: ClinicalTrials.gov NCT04838977. 8 April 2021.

摘要

背景:四分之一到一半的受伤儿童会出现创伤后应激症状,影响其长期的心理和身体健康。现已有针对创伤后应激的循证护理,但在某些社区并不容易获得。我们开发了一个电子健康计划,该计划由基于创伤聚焦认知行为疗法的在线互动教育模块和远程健康治疗师支持组成,名为“减轻创伤后压力(ReSeT)计划”。我们假设,参加 ReSeT 的创伤后应激儿童与常规护理对照组相比,症状会更少。

方法:这是一项随机对照试验,旨在测试 ReSeT 干预措施在减少创伤后应激症状方面与常规护理对照组相比的有效性。从四个参与的创伤中心招募并随机选择 106 名 8-17 岁的儿童,这些儿童在受伤后住院,受伤后 4 周出现创伤后应激症状。将在两组之间比较的结果包括 10 周时的创伤后应激症状(主要结局),同时控制基线症状和随机分组后 6 个月时的创伤后应激症状(次要结局)。

讨论:ReSeT 是一个基于循证的计划,旨在通过电子健康平台减少受伤儿童的创伤后应激症状。目前,美国外科医师学院的标准建议创伤计划在创伤系统中识别和治疗有心理健康需求高风险的患者。如果证明有效,ReSeT 可以帮助增加创伤系统中创伤后应激儿童获得循证护理的机会。

试验注册:ClinicalTrials.gov NCT04838977. 2021 年 4 月 8 日。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f597/10683223/fe962abdb881/13063_2023_7806_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f597/10683223/fe962abdb881/13063_2023_7806_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f597/10683223/fe962abdb881/13063_2023_7806_Fig1_HTML.jpg

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本文引用的文献

[1]
Association of Emergency Department Pediatric Readiness With Mortality to 1 Year Among Injured Children Treated at Trauma Centers.

JAMA Surg. 2022-4-1

[2]
Post-traumatic Stress Disorder in Parents Following Their Child's Single-Event Trauma: A Meta-Analysis of Prevalence Rates and Risk Factor Correlates.

Clin Child Fam Psychol Rev. 2021-12

[3]
COVID-19 Exposure and Family Impact Scales: Factor Structure and Initial Psychometrics.

J Pediatr Psychol. 2021-6-3

[4]
Clinical Validity of the PROMIS Pediatric Sleep Measures across Populations of Children with Chronic Illnesses and Neurodevelopment Disorders.

J Pediatr Psychol. 2020-4-1

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Value Health. 2019-5

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Clin Child Fam Psychol Rev. 2019-6

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When and how should multiple imputation be used for handling missing data in randomised clinical trials - a practical guide with flowcharts.

BMC Med Res Methodol. 2017-12-6

[9]
Mobile Health Interventions for Improving Health Outcomes in Youth: A Meta-analysis.

JAMA Pediatr. 2017-5-1

[10]
What five decades of research tells us about the effects of youth psychological therapy: A multilevel meta-analysis and implications for science and practice.

Am Psychol. 2017

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