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Purrble with LGBTQ+ Youth Who Have Self-harmful Thoughts

K

King's College London

Status

Completed

Conditions

Emotion Regulation
Self Harm

Treatments

Behavioral: Purrble intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT06025942
RESCM-22/23-34570

Details and patient eligibility

About

The primary aim of the proposed Randomised Control study is to investigate the effects of a socially assisted robot (i.e. Purrble) on emotional regulation difficulties (measured by DERS8) with young LGBTQ+ people who have self-harmful (with or without suicidal intention) (in comparison to a wait-listed control).

Secondary aims include investigating the effects of the Purrble on young people's self-harmful thoughts, symptoms of anxiety and depression, alongside quantitative and qualitative (interviews) measures of engagement with the intervention.

Full description

Self-harm is a key concern among young people, this is highlighted by the rising rates self-harm and suicide attempts in recent years. Internationally, young LGBTQ+ people are recognised to report higher prevalence of self-harmful thoughts, behaviours, anxiety and depression than their cisgender, heterosexual peers. Emotion regulation (ER) is known to be a transdiagnostic risk factor, which is widely associated with higher risk of self-harm. Typically, LGBTQ+ populations also report greater difficulties with ER which partially explains association with self-harm.

While LGBTQ+ youth are frequent users of digital technologies and digital interventions are often considered feasible and acceptable, there is limited evidence of the effectiveness of such within these populations. Currently, there is no evidence-based digital interventions targeting LGBTQ+ youth who struggle with self-harm.

To address this gap, the investigators have conducted a small pilot study (n=21) to evaluated one such possible tool - Purrble - as a means to offer in-the-moment emotional support for those with high levels of self-harm risk (high symptoms of anxiety, depression, or self-harmful experiences in the last 6 months). The goals of the study centre around testing the feasibility, acceptability, and usage of Purrble across a 2-week deployment period. These results have been promising, indicating Purrble as a feasible and acceptable intervention, alongside indicators of clinical value during Purrble deployment: i) reduction of anxiety and depression symptoms during deployment and ii) reduced prevalence of self-harm thoughts.

From previous interviews, participants highlighted the positive outcomes which were associated with Purrble use (stopping them reaching the point of thinking about self-harm, being a barrier to self-harm behaviours, and encouraging emotional regulation coping strategies; e.g. grounding, self-soothing). However, these pilot studies did not include a controlled waitlist group, and thus more rigorous investigation of these promising effects is needed - leading to the current study.

Enrollment

155 patients

Sex

All

Ages

16 to 25 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Currently experiencing self-harmful thoughts (within the last month) Identify as sexual orientation or gender identity minority (LGBTQ+) Aged 16-25 years Currently living in the UK at the time of the study Able to read and write in English

Exclusion criteria

Young people who live outside the UK, are not within the 16-25 year age bracket, and are not experiencing self-harmful thoughts will not be included in the study.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

155 participants in 2 patient groups

Intervention
Experimental group
Description:
The Purrble intervention takes the form of an interactive plush toy, designed to be handed over to the young person and support in-the-moment soothing.
Treatment:
Behavioral: Purrble intervention
Control
No Intervention group
Description:
Wait-list control (access to services as usual)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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