Slovak Petr, Ford Brett Q, Widen Sherri, Daudén Roquet Claudia, Theofanopoulou Nikki, Gross James J, Hankin Benjamin, Klasnja Predrag
Department of Informatics, King's College London, London, United Kingdom.
Psychology Department, University of Toronto, Toronto, ON, Canada.
JMIR Res Protoc. 2021 Nov 9;10(11):e28914. doi: 10.2196/28914.
Emotion regulation is a key transdiagnostic risk factor for a range of psychopathologies, making it a prime target for both prevention and treatment interventions in childhood. Existing interventions predominantly rely on workshops or in-person therapy-based approaches, limiting the ability to promote emotion regulation competence for children in everyday settings and at scale. Purrble is a newly developed, inexpensive, socially assistive robot-in the form of an interactive plush toy-that uses haptic feedback to support in-the-moment emotion regulation. It is accessible to children as needed in their daily lives, without the need for a priori training. Although qualitative data from previous studies show high engagement in situ and anecdotal evidence of the robot being incorporated into children's emotion regulation routines, there is no quantitative evidence of the intervention's impact on child outcomes.
The aim of this study is to examine the efficacy of a new intervention model for child-led emotion regulation-Purrble-that can be deployed across prevention and treatment contexts.
Overall, 134 children aged 8 to 10 years will be selected from an enriched nonclinical North American population; for inclusion, the cutoff for the parents' rating of child dysregulation will be ≥10 points in the total difficulties score on the Strengths and Difficulties Questionnaire. This cutoff was selected to obtain a measurable, but not necessarily clinical, level of the child's emotion regulatory difficulties. The selected families will be randomly assigned with .5 probability to receive either a Purrble or an active control (noninteractive plush toy). The primary outcome will be a daily ecological momentary assessment measure of child emotion regulation capability (as reported by parents) over a period of 4 weeks. Exploratory analyses will investigate the intervention impact on secondary outcomes of child emotion regulation, collected weekly over the same 4-week period, with follow-ups at 1 month and 6 months postdeployment. Quantitative data will be analyzed on an intent-to-treat basis. A proportion of families (approximately 30% of the sample) will be interviewed after deployment as part of the process analysis.
The study is funded by the UKRI Future Leaders Fellowship (MR/T041897/1) and an in-kind contribution from the Committee for Children. This study received ethical approval from the Pearl institutional review board (#18-CFC-101). Participant recruitment started in February 2021, with the 1-month deployment in April-May 2021. The results of this analysis will be published in 2022.
This study will be the first quantitative evaluation of the efficacy of an innovative, proof-of-concept intervention model for an in situ, child-led emotion regulation intervention. Insights into the trajectory of daily changes, complemented with weekly questionnaire batteries and postdeployment interviews, will result in an in-depth understanding of whether and how the hypothesized intervention logic model works, leading to further intervention optimization.
ClinicalTrials.gov NCT04810455; http://clinicaltrials.gov/ct2/show/NCT04810455.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/28914.
情绪调节是一系列精神病理学的关键跨诊断风险因素，使其成为儿童预防和治疗干预的主要目标。现有的干预措施主要依赖于工作坊或基于面对面治疗的方法，限制了在日常环境中大规模促进儿童情绪调节能力的能力。Purrble是一种新开发的、价格低廉的社交辅助机器人，它是一个交互式毛绒玩具，利用触觉反馈来支持即时情绪调节。孩子们在日常生活中根据需要即可使用它，无需事先培训。尽管先前研究的定性数据显示该机器人在现场具有很高的参与度，并且有轶事证据表明它已被纳入儿童的情绪调节日常习惯中，但尚无定量证据证明该干预措施对儿童结果的影响。
本研究的目的是检验一种新的、由儿童主导的情绪调节干预模型——Purrble——在预防和治疗环境中的有效性。
总体而言，将从北美丰富的非临床人群中挑选134名8至10岁的儿童；纳入标准为，父母对儿童失调的评分在优势与困难问卷的总困难得分中≥10分。选择这个临界值是为了获得儿童情绪调节困难的可测量但不一定是临床水平。选定的家庭将以0.5的概率随机分配，分别接受Purrble或积极对照（非交互式毛绒玩具）。主要结果将是在4周内对儿童情绪调节能力（由父母报告）进行的每日生态瞬时评估测量。探索性分析将调查该干预措施对儿童情绪调节次要结果的影响，这些结果在相同的4周内每周收集一次，并在部署后1个月和6个月进行随访。定量数据将基于意向性分析进行分析。一部分家庭（约占样本的30%）将在部署后接受访谈，作为过程分析的一部分。
本研究由英国研究与创新署未来领袖奖学金（MR/T041897/1）以及儿童委员会的实物捐赠资助。本研究获得了Pearl机构审查委员会（#18-CFC-101）的伦理批准。参与者招募于2021年2月开始，2021年4月至5月进行为期1个月的部署。本分析的结果将于2022年发表。
本研究将是对一种创新的、概念验证干预模型在现场由儿童主导的情绪调节干预有效性的首次定量评估。对每日变化轨迹的洞察，辅以每周的问卷调查和部署后的访谈，将深入了解假设的干预逻辑模型是否以及如何起作用，从而实现进一步的干预优化。
ClinicalTrials.gov NCT04810455；http://clinicaltrials.gov/ct2/show/NCT04810455。
国际注册报告识别码（IRRID）：PRR1-10.2196/28914。
