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. 2024 Jan 9;14(1):e079801.
doi: 10.1136/bmjopen-2023-079801.

Enhancing emotion regulation with an in situ socially assistive robot among LGBTQ+ youth with self-harm ideation: protocol for a randomised controlled trial

Collaborators, Affiliations

Enhancing emotion regulation with an in situ socially assistive robot among LGBTQ+ youth with self-harm ideation: protocol for a randomised controlled trial

A Jess Williams et al. BMJ Open. .

Abstract

Introduction: Purrble, a socially assistive robot, was codesigned with children to support in situ emotion regulation. Preliminary evidence has found that LGBTQ+ youth are receptive to Purrble and find it to be an acceptable intervention to assist with emotion dysregulation and their experiences of self-harm. The present study is designed to evaluate the impact of access to Purrble among LGBTQ+ youth who have self-harmful thoughts, when compared with waitlist controls.

Methods and analysis: The study is a single-blind, randomised control trial comparing access to the Purrble robot with waitlist control. A total of 168 LGBTQ+ youth aged 16-25 years with current self-harmful ideation will be recruited, all based within the UK. The primary outcome is emotion dysregulation (Difficulties with Emotion Regulation Scale-8) measured weekly across a 13-week period, including three pre-deployment timepoints. Secondary outcomes include self-harm (Self-Harm Questionnaire), anxiety (Generalised Anxiety Disorder-7) and depression (Patient Health Questionnaire-9). We will conduct analyses using linear mixed models to assess primary and secondary hypotheses. Intervention participants will have unlimited access to Purrble over the deployment period, which can be used as much or as little as they like. After all assessments, control participants will receive their Purrble, with all participants keeping the robot after the end of the study. After the study has ended, a subset of participants will be invited to participate in semistructured interviews to explore engagement and appropriation of Purrble, considering the young people's own views of Purrble as an intervention device.

Ethics and dissemination: Ethical approval was received from King's College London (RESCM-22/23-34570). Findings will be disseminated in peer review open access journals and at academic conferences.

Trial registration number: NCT06025942.

Keywords: adolescents; mental health; protocols & guidelines; randomized controlled trial; sexual and gender minorities; suicide & self-harm.

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Conflict of interest statement

Competing interests: PS has been involved in the development of what is now Purrble as part of his postdoctoral fellowship and serves as a paid research adviser to the Committee for Children (CfC) but has no financial stake in either CfC (Purrble brand owners) or Sproutel (company manufacturing Purrbles). Neither Committee for Children nor Sproutel had access to the data or had been part of the data collection in any way nor did they approve or see the publication before it was submitted. There were no conflicting interests among the remaining research team.

Figures

Figure 1
Figure 1
Purrble—socially assistive robot.

References

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