Enhancing emotion regulation with an in situ socially assistive robot among LGBTQ+ youth with self-harm ideation: protocol for a randomised controlled trial
This document is a study protocol for a single-blind, randomised controlled trial evaluating the impact of providing access to the Purrble socially assistive robot among LGBTQ+ youth aged 16 to 25 with self-harm ideation. The trial compares unlimited access to the Purrble robot over a 10-week deployment period against a waitlist control group, measuring outcomes such as emotion regulation difficulties, self-harm frequency, anxiety, and depression symptoms. The study aims to provide robust quantitative evidence on whether socially assistive robots can support in-situ emotion regulation and mental health for vulnerable minority youth.
Summary and content fields are drawn from the document text and are pending editorial review.
Who issued it
Who it governs
Researchers, clinicians, and digital health developers interested in evaluating technology-based mental health interventions for minority youth should read this protocol.
What the document contains
This protocol details the design, methodology, recruitment strategies, and statistical analysis plan for a randomised controlled trial testing a socially assistive robot intervention. It covers eligibility criteria, primary and secondary outcome measures, sample size calculations, safeguarding procedures, and plans for patient and public involvement.
The document does not contain the final trial results, clinical data, or safety findings, as it is solely a methodological study protocol.
- The study evaluates the impact of the Purrble socially assistive robot on emotion regulation difficulties among LGBTQ+ youth with self-harm ideation.
- A total of 168 LGBTQ+ youth aged 16-25 in the UK will be recruited for a 13-week single-blind randomised controlled trial comparing the robot intervention against a waitlist control.
- Primary outcomes focus on emotion dysregulation, while secondary outcomes examine self-harm thoughts, anxiety, and depression symptoms.
- Qualitative semistructured interviews will be conducted with a subset of participants following deployment to explore engagement and appropriation of the device.
· Introduction · Methods and analysis · Study objectives · Trial design · Intervention · Waitlist-control · Participants · Recruitment, randomisation and blinding · Power analysis · Outcome measures · Post deployment interviews · Hypotheses · Statistical analyses · Patient and public involvement · Ethics and dissemination
How it scores
Each score is backed by a quote verified against the document text. Editorial review has not yet confirmed them.
Accountability
0/5Clear responsibility for AI outcomes
None
screening score · 2026-10-23
Human Dignity
1/5Respect for the inherent worth of persons
The study was codesigned with young people who have experience of mental health difficulties (Sprouting Minds), including a detailed safeguarding procedure.
Strengths and limitations of this study
screening score · 2026-10-23
Privacy
0/5Protection of personal data and private life
None
screening score · 2026-10-23
Transparency
0/5Openness about how AI systems work and are used
None
screening score · 2026-10-23
Enforcement
0/5Consequences and compliance mechanisms with real force
None
screening score · 2026-10-23
Impact Assessment
0/5Required assessment of an AI system's risks/impacts before or during use
None
screening score · 2026-10-23