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Purrble With LGBTQ+ Youth Who Have Self-harmful Thoughts

Primary Purpose

Emotion Regulation, Self Harm

Status
Not yet recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Purrble intervention
Sponsored by
King's College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Emotion Regulation focused on measuring LGBTQ, Self-harm, Emotion regulation, Young people, RCT

Eligibility Criteria

16 Years - 25 Years (Child, Adult)All SexesAccepts 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.

Sites / Locations

  • King's College London

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm 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.

Wait-list control (access to services as usual)

Outcomes

Primary Outcome Measures

Emotion regulation (DERS8)
Across the trial, we hypothesise that access to the Purrble intervention (compared to the waitlist control) will lead to a decrease in self-reported difficulties with emotion regulation as measured by the primary outcome (DERS8). We will compare the DERS8 assessment pre-deployment (calculated as the average of DERS scores across baseline weeks 1-3) and final deployment assessments (averaged across weeks 11-13). Measured by: Difficulties with Emotional Regulation Scale-8 (DERS8), an 8-item instrument used to measure or assess the difficulties with regulating emotion [22]. The DERS8 score is calculated using a 5-point Likert scale, ranging from 1 (almost never, 0-10%) to 5 (almost always 91-100%). These scores are added together to form a total score (8-40). Higher scores indicate greater levels of difficulty associated with response to situations eliciting negative emotions.

Secondary Outcome Measures

Self-harmful thoughts (SHQ)
A secondary aim to evaluate the impact of the Purrble intervention on young LGBTQ+ people's self-harmful ideation (with and without suicidal intention), compared to waiting list controls. Measured by: The Self-Harm Questionnaire (SHQ; [23]). While the whole instrument is used at baseline (T0), offering a greater level of detail as to why someone has self-harmed, and only the three screener items will be used across deployment. These question the presence of self-harmful thoughts (without suicidal intentions), suicidal thoughts, and whether the young person has harmed themselves on purpose. The screener assigns scores of 1 (no), 2 (yes, once), 3 (yes, two, three or four times), and 4 (yes, five or more times) - offering a general idea of frequency of self-harmful thoughts.
Anxiety (GAD7)
A secondary aim is to investigate the effects of Purrble on reports of anxiety symptoms within young LGBTQ+ people who have current experiences of self-harmful ideation (in comparison to a wait-listed group). Measured by: Generalised Anxiety Disorder Assessment (GAD-7; [24]), a seven-item instrument that is used to measure or assess the severity of generalised anxiety disorder. Each item asks the individual to rate the severity of their symptoms over the past two weeks. The GAD-7 score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of "not at all," "several days," "more than half the days," and "nearly every day," respectively, and then adding together the scores for the seven questions (score range: 0-21). Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively.
Depression (PHQ-9)
A secondary aim is to investigate the effects of Purrble on reports of depressive symptoms within young people who have current experiences of self-harmful ideation (in comparison to a wait-listed group). Measured by: Patient Health Questionnaire-9 (PHQ-9; [25]) , a depression module which scores each of the nine DSM-IV criteria as "0" (not at all) to "3" (nearly every day). It is not a screening tool for depression but it is used to monitor the severity of depression and response to treatment. The maximum score is 27 (9 questions x maximum 3 points per question). Depression severity is graded based on the PHQ-9 score: None 0-4 Mild 5-9 Moderately 10-14 Moderately severe 15-19 Severe 20-27.

Full Information

First Posted
August 29, 2023
Last Updated
September 6, 2023
Sponsor
King's College London
Collaborators
University of Oxford, University of Nottingham, University of Glasgow, Stanford University, University of Melbourne
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1. Study Identification

Unique Protocol Identification Number
NCT06025942
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
March 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King's College London
Collaborators
University of Oxford, University of Nottingham, University of Glasgow, Stanford University, University of Melbourne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emotion Regulation, Self Harm
Keywords
LGBTQ, Self-harm, Emotion regulation, Young people, RCT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
168 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm 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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Wait-list control (access to services as usual)
Intervention Type
Behavioral
Intervention Name(s)
Purrble intervention
Intervention Description
When the Purrble is picked up, it emits a frantic heartbeat that slows down if the person uses calm stroking movements. If the Purrble is soothed for long enough, it transitions into a purring vibration indicating a calm, content state. Logic model underlying the intervention: Level 1: in-the-moment soothing support to young people in emotional moments when they would attempt to utilise emotion regulation (ER) strategies to calm down. Level 2: mechanisms that facilitate long-term engagement with the intervention, building on positive subjective experience of Level 1. Level 3: shift in young peoples' ER practices and implicit beliefs about emotion, after repeated experience of Levels 1-2. see JMIR Res Protoc 2021;10(11):e28914 (doi: 10.2196/28914)
Primary Outcome Measure Information:
Title
Emotion regulation (DERS8)
Description
Across the trial, we hypothesise that access to the Purrble intervention (compared to the waitlist control) will lead to a decrease in self-reported difficulties with emotion regulation as measured by the primary outcome (DERS8). We will compare the DERS8 assessment pre-deployment (calculated as the average of DERS scores across baseline weeks 1-3) and final deployment assessments (averaged across weeks 11-13). Measured by: Difficulties with Emotional Regulation Scale-8 (DERS8), an 8-item instrument used to measure or assess the difficulties with regulating emotion [22]. The DERS8 score is calculated using a 5-point Likert scale, ranging from 1 (almost never, 0-10%) to 5 (almost always 91-100%). These scores are added together to form a total score (8-40). Higher scores indicate greater levels of difficulty associated with response to situations eliciting negative emotions.
Time Frame
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 Outcome Measure Information:
Title
Self-harmful thoughts (SHQ)
Description
A secondary aim to evaluate the impact of the Purrble intervention on young LGBTQ+ people's self-harmful ideation (with and without suicidal intention), compared to waiting list controls. Measured by: The Self-Harm Questionnaire (SHQ; [23]). While the whole instrument is used at baseline (T0), offering a greater level of detail as to why someone has self-harmed, and only the three screener items will be used across deployment. These question the presence of self-harmful thoughts (without suicidal intentions), suicidal thoughts, and whether the young person has harmed themselves on purpose. The screener assigns scores of 1 (no), 2 (yes, once), 3 (yes, two, three or four times), and 4 (yes, five or more times) - offering a general idea of frequency of self-harmful thoughts.
Time Frame
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]
Title
Anxiety (GAD7)
Description
A secondary aim is to investigate the effects of Purrble on reports of anxiety symptoms within young LGBTQ+ people who have current experiences of self-harmful ideation (in comparison to a wait-listed group). Measured by: Generalised Anxiety Disorder Assessment (GAD-7; [24]), a seven-item instrument that is used to measure or assess the severity of generalised anxiety disorder. Each item asks the individual to rate the severity of their symptoms over the past two weeks. The GAD-7 score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of "not at all," "several days," "more than half the days," and "nearly every day," respectively, and then adding together the scores for the seven questions (score range: 0-21). Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively.
Time Frame
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]
Title
Depression (PHQ-9)
Description
A secondary aim is to investigate the effects of Purrble on reports of depressive symptoms within young people who have current experiences of self-harmful ideation (in comparison to a wait-listed group). Measured by: Patient Health Questionnaire-9 (PHQ-9; [25]) , a depression module which scores each of the nine DSM-IV criteria as "0" (not at all) to "3" (nearly every day). It is not a screening tool for depression but it is used to monitor the severity of depression and response to treatment. The maximum score is 27 (9 questions x maximum 3 points per question). Depression severity is graded based on the PHQ-9 score: None 0-4 Mild 5-9 Moderately 10-14 Moderately severe 15-19 Severe 20-27.
Time Frame
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 Pre-specified Outcome Measures:
Title
Emotion regulation (PMERQ)
Description
An additional aim is to examine the levels of endorsement for attentional deployment among LGBTQ+ youth; we hypothesise that those with access to Purrble will score higher than those in the waitlist control. Measured by: The Process Model of Emotion Regulation Questionnaire (PMERQ; [26]), a 45-item measure which considers 10 ER strategies across the five stages of the Process Model of ER, and particularly how these strategies are used to decrease negative emotions. A Likert-scale is used, scoring 1 (strongly disagree) to 6 (strongly agree). We only include 2 subscales which focus on attention deployment (focusing elsewhere - 4-items (4-24) and cognitive distraction 5-items (5-30)). Each subscale is scored by taking the average of item-level responses, with higher scores indicating greater endorsement.
Time Frame
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]
Title
Hopefulness (SHS)
Description
An additional aim is to examine the levels of hope among LGBTQ+ youth; we hypothesise that those with access to Purrble will score higher than those in the waitlist control. Measured by: The State Hope Scale (SHS; [27]) is a 6-item self-report measure of ongoing goal-directed thinking (agency and pathways). Responses are rated on an 8-point Likert scale ranging from 1 (Definitely True) to 8 (Definitely False) with higher scores indicative of greater state hopefulness (total score: 6-48).
Time Frame
[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]
Title
Loneliness (UCLA)
Description
An additional aim is to examine the levels of loneliness among LGBTQ+ youth; we hypothesise that those with access to Purrble will score lower than those in the waitlist control. The UCLA Loneliness scale for children [28]) is a 3-item measure used to assess loneliness using 3 responses; 1 (hardly ever or never), 2 (some of the time), and 3 (often). Scores range from 3-12, with higher scores indicating greater levels of loneliness.
Time Frame
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]
Title
Engagement with the Purrble intervention (TWEETS)
Description
An additional aim includes investigating the engagements with the Purrble over the 10-week deployment period among intervention participants. Measured by: Measured by: An adapted version of Twente Engagement with eHealth Technologies Scale (TWEETS; [29]). Consisting of 9-items measured on a 5-point Likert scale ranging from strongly disagree (0) to strongly agree (4), total score ranging from 0-36. Engagement is split into subsections considering behaviour, cognitive and affective engagement. Higher scores indicate greater engagement with the intervention.
Time Frame
all timepoints following deployment for intervention group [Time frame: Ten times during the 10-week long deployment period (week 4-13)]
Title
Engagement with the Purrble intervention
Description
An additional aim includes investigating the engagements with the Purrble over the 10-week deployment period among intervention participants. Measured by: A bespoke survey informed by the previous Purrble research [30]. The questions inquire about Purrble use and perceived usefulness. Items are rated on a 0 to 4 scale unless otherwise specified. How often did participants engage with Purrble this week? If not at all, why do participants think that was? On average, did engaging with Purrble make any difference to how participants felt at the time?
Time Frame
all timepoints following deployment for intervention group [Time frame: Ten times during the 10-week long deployment period (week 4-13)]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
King's College London
City
London
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
A. Jess Williams, PhD
Phone
020 7848 1988
Email
amy_jess.williams@kcl.ac.uk
First Name & Middle Initial & Last Name & Degree
Petr Slovak, PhD
Phone
020 7848 1988
Email
petr.slovak@kcl.ac.uk
First Name & Middle Initial & Last Name & Degree
Seonaid Cleare, PhD

12. IPD Sharing Statement

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Purrble With LGBTQ+ Youth Who Have Self-harmful Thoughts

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