An In Situ, Child-Led Intervention to Promote Emotion Regulation Competence in Middle Childhood: Protocol for an Exploratory Randomized Controlled Trial.
An In Situ, Child-Led Intervention to Promote Emotion Regulation Competence in Middle Childhood: Protocol for an Exploratory Randomized Controlled Trial.
复制标题
一个原位，儿童主导的干预，以促进情绪调节能力在童年中期：协议的探索性随机对照试验。
DOI：
10.2196/28914
复制
发表时间：
2021-11-09
影响因子：
1.7
通讯作者：
Klasnja P
中科院分区：
文献类型：
--
作者：
Slovak P;Ford BQ;Widen S;Daudén Roquet C;Theofanopoulou N;Gross JJ;Hankin B;Klasnja P
情绪调节是一系列精神病理学的关键转诊断风险因素，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研讨会或面对面的治疗方法，限制了在日常环境中和规模上促进儿童情绪调节能力的能力。Purrble是一个新开发的，廉价的，社会辅助机器人，以互动毛绒玩具的形式，它使用触觉反馈来支持即时的情绪调节。儿童在日常生活中有需要时可以使用，而不需要事先培训。虽然从以前的研究定性数据显示，高参与现场和轶事证据的机器人被纳入儿童的情绪调节程序，有没有定量的证据干预的影响儿童的结果。本研究的目的是研究一种新的干预模式的有效性，为儿童主导的情绪调节-Purrble-可以部署在预防和治疗的情况。总体而言，将从丰富的非临床北美人群中选择134名8 - 10岁儿童;对于入选，父母对儿童调节障碍的评分临界值为优势和困难问卷的总困难评分≥10分。选择这个截止值是为了获得一个可测量的，但不一定是临床的，儿童情绪调节困难的水平。被选中的家庭将被随机分配到一个Purrble或一个主动控制（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）进行每日生态瞬时评估。探索性分析将调查干预对儿童情绪调节次要结局的影响，在相同的4周期间每周收集一次，并在部署后1个月和6个月进行随访。定量数据将在意向治疗基础上进行分析。作为过程分析的一部分，将在部署后对一部分家庭（约占样本的30%）进行访谈。这项研究由英国研究所未来领导人奖学金（MR/T041897/1）和儿童委员会的实物捐助资助。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，并于2021年4月至5月进行为期1个月的部署。分析结果将于2022年公布。这项研究将是第一个定量评估的有效性的创新，概念验证的干预模型，在现场，儿童主导的情绪调节干预。对日常变化轨迹的洞察，加上每周一次的问卷调查和部署后访谈，将深入了解假设的干预逻辑模型是否以及如何运作，从而进一步优化干预。ClinicalTrials.gov NCT 04810455; http://clinicaltrials.gov/ct2/show/NCT04810455 PRR1-10.2196/28914
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 PRR1-10.2196/28914
登录
查看更多内容
影响因子：
7.6
作者：
BARON, RM;KENNY, DA
通讯作者：
KENNY, DA
影响因子：
3.5
作者：
Cosley, Brandon J.;McCoy, Shannon K.;Epel, Elissa S.
通讯作者：
Epel, Elissa S.
影响因子：
1.5
作者：
Crossman, Molly K.;Kazdin, Alan E.;Kitt, Elizabeth R.
通讯作者：
Kitt, Elizabeth R.
影响因子：
4
作者：
DUNN, J;BROWN, J;BEARDSALL, L
通讯作者：
BEARDSALL, L
影响因子：
2.6
作者：
De Castella, Krista;Platow, Michael J.;Gross, James J.
通讯作者：
Gross, James J.