Clinical trial NCT06025942: Purrble With LGBTQ+ Youth Who Have Self-harmful Thoughts
Official title: Enhancing Emotion Regulation With an In-situ Socially Assistive Robot Among LGBTQ+ Youth With Self-harm Ideation: a Randomised Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emotion Regulation
Self Harm
Keywords: LGBTQ
Self-harm
Emotion regulation
Young people
RCT
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: University of Oxford
name: University of Nottingham
name: University of Glasgow
name: Stanford University
name: University of Melbourne
First posted: 2023-09-06
Enrollment: 155
Sex: ALL
Minimum age (years): 16
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Emotion regulation (DERS8)
timeFrame: all timepoints [Time Frame: Three times during pre-deployment (week 1-3) and ten times during the 10-week long deployment period (week 4-13) = total of 13 times]
Secondary outcomes:
measure: Self-harmful thoughts (SHQ)
timeFrame: all timepoints [Time Frame: Three times during pre-deployment (week 1-3) and ten times during the 10-week long deployment period (week 4-12) = total of 13 times]
measure: Anxiety (GAD7)
timeFrame: all timepoints [Time Frame: Three times during pre-deployment (week 1-3) and ten times during the 10-week long deployment period (week 4-13) = total of 13 times]
measure: Depression (PHQ-9)
timeFrame: all timepoints [Time Frame: Three times during pre-deployment (week 1-3) and ten times during the 10-week long deployment period (week 4-13) = total of 13 times]
Other outcomes:
measure: Emotion regulation (PMERQ)
timeFrame: 3 timepoints [Timeframe: Once during pre-deployment (week 3 [T0]) and twice during the 10 -week long deployment period (week 8 [T5], week 13 [T10]) = total of 3 times]
measure: Hopefulness (SHS)
timeFrame: [Timeframe: Once during pre-deployment (week 3 [T0]) and twice during the 10 -week long deployment period (week 8 [T5], week 13 [T10]) = total of 3 times]
measure: Loneliness (UCLA)
timeFrame: 3 timepoints [Timeframe: Once during pre-deployment (week 3 [T0]) and twice during the 10 -week long deployment period (week 8 [T5], week 13 [T10]) = total of 3 times]
measure: Engagement with the Purrble intervention (TWEETS)
timeFrame: all timepoints following deployment for intervention group [Time frame: Ten times during the 10-week long deployment period (week 4-13)]
measure: Engagement with the Purrble intervention
timeFrame: all timepoints following deployment for intervention group [Time frame: Ten times during the 10-week long deployment period (week 4-13)]
Locations:
city: London
country: United Kingdom
facility: King's College London
Study officials:
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