Accepted for/Published in: JMIR Research Protocols
Date Submitted: Apr 6, 2021
Date Accepted: May 25, 2021
An In-situ, Child-led Intervention To Promote Emotion Regulation Competence in Middle Childhood: Protocol For an Exploratory Randomised Control Trial
ABSTRACT
Background:
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 workshop 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—which uses haptic feedback to support in-the-moment emotion regulation. It is accessible to children as needed in their daily lives, without the requirement for a priori training. While qualitative data from prior studies show high engagement in-situ and anecdotal evidence of the robot being incorporated into children’s emotion regulation routines, there is so far no quantitative evidence of the intervention’s impact on child outcomes.
Objective:
The aim of this study is to examine, for the first time, the efficacy of a new intervention model for child-led emotion regulation—Purrble—that could be deployed across prevention and treatment contexts.
Methods:
A total of 120 children aged 8-10 will be selected from an `enriched’ non-clinical US population: for inclusion, the cutoff for parent’s rating of child dysregulation will be 10 points or higher on the total difficulties score on the Strengths and Difficulties Questionnaire. This cutoff selects for 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 Purrble or an active control (non-interactive plush toy). The primary outcome will be a daily EMA 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 post-deployment. Quantitative data will be analysed on an intent-to-treat basis. A proportion of families (~30% of the sample) will be interviewed post deployment as part of process analysis.
Results:
The study is funded by UKRI Future Leaders Fellowship (MR/T041897/1) and an in-kind contribution from Committee for Children. It received ethical approval from the Pearl IRB (#18-CFC-101). Participant recruitment will start in February 2021, with the 1 month deployment expected in April - May 2021. The results of the analysis will be published in 2021.
Conclusions:
The 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. The insights into the trajectory of daily changes, complemented with weekly questionnaire batteries and post-deployment interviews will result in an in-depth understanding of whether, and how the hypothesised intervention logic model works, leading to further intervention optimisation.
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