xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06025942</url>
    </required_header>
    <id_info>
      <org_study_id>RESCM-22/23-34570</org_study_id>
      <nct_id>NCT06025942</nct_id>
    </id_info>
    <brief_title>Purrble With LGBTQ+ Youth Who Have Self-harmful Thoughts</brief_title>
    <official_title>Enhancing Emotion Regulation With an In-situ Socially Assistive Robot Among LGBTQ+ Youth With Self-harm Ideation: a Randomised Control Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>King's College London</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of Oxford</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Nottingham</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Glasgow</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Stanford University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Melbourne</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>King's College London</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The primary aim of the proposed Randomised Control study is to investigate the effects of a&#xD;
        socially assisted robot (i.e. Purrble) on emotional regulation difficulties (measured by&#xD;
        DERS8) with young LGBTQ+ people who have self-harmful (with or without suicidal intention)&#xD;
        (in comparison to a wait-listed control).&#xD;
  &#xD;
        Secondary aims include investigating the effects of the Purrble on young people's&#xD;
        self-harmful thoughts, symptoms of anxiety and depression, alongside quantitative and&#xD;
        qualitative (interviews) measures of engagement with the intervention.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Self-harm is a key concern among young people, this is highlighted by the rising rates&#xD;
        self-harm and suicide attempts in recent years. Internationally, young LGBTQ+ people are&#xD;
        recognised to report higher prevalence of self-harmful thoughts, behaviours, anxiety and&#xD;
        depression than their cisgender, heterosexual peers. Emotion regulation (ER) is known to be a&#xD;
        transdiagnostic risk factor, which is widely associated with higher risk of self-harm.&#xD;
        Typically, LGBTQ+ populations also report greater difficulties with ER which partially&#xD;
        explains association with self-harm.&#xD;
  &#xD;
        While LGBTQ+ youth are frequent users of digital technologies and digital interventions are&#xD;
        often considered feasible and acceptable, there is limited evidence of the effectiveness of&#xD;
        such within these populations. Currently, there is no evidence-based digital interventions&#xD;
        targeting LGBTQ+ youth who struggle with self-harm.&#xD;
  &#xD;
        To address this gap, the investigators have conducted a small pilot study (n=21) to evaluated&#xD;
        one such possible tool - Purrble - as a means to offer in-the-moment emotional support for&#xD;
        those with high levels of self-harm risk (high symptoms of anxiety, depression, or&#xD;
        self-harmful experiences in the last 6 months). The goals of the study centre around testing&#xD;
        the feasibility, acceptability, and usage of Purrble across a 2-week deployment period. These&#xD;
        results have been promising, indicating Purrble as a feasible and acceptable intervention,&#xD;
        alongside indicators of clinical value during Purrble deployment: i) reduction of anxiety and&#xD;
        depression symptoms during deployment and ii) reduced prevalence of self-harm thoughts.&#xD;
  &#xD;
        From previous interviews, participants highlighted the positive outcomes which were&#xD;
        associated with Purrble use (stopping them reaching the point of thinking about self-harm,&#xD;
        being a barrier to self-harm behaviours, and encouraging emotional regulation coping&#xD;
        strategies; e.g. grounding, self-soothing). However, these pilot studies did not include a&#xD;
        controlled waitlist group, and thus more rigorous investigation of these promising effects is&#xD;
        needed - leading to the current study.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 1, 2023</start_date>
    <completion_date type="Anticipated">March 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Emotion regulation (DERS8)</measure>
      <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]</time_frame>
      <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).&#xD;
  Measured by: Difficulties with Emotional Regulation Scale-8 (DERS8), an 8-item instrument used to measure or assess the difficulties with regulating emotion [22].&#xD;
  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.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Self-harmful thoughts (SHQ)</measure>
      <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]</time_frame>
      <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.&#xD;
  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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Anxiety (GAD7)</measure>
      <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]</time_frame>
      <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).&#xD;
  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.&#xD;
  The GAD-7 score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of &quot;not at all,&quot; &quot;several days,&quot; &quot;more than half the days,&quot; and &quot;nearly every day,&quot; 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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Depression (PHQ-9)</measure>
      <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]</time_frame>
      <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).&#xD;
  Measured by: Patient Health Questionnaire-9 (PHQ-9; [25]) , a depression module which scores each of the nine DSM-IV criteria as &quot;0&quot; (not at all) to &quot;3&quot; (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.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Emotion regulation (PMERQ)</measure>
      <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]</time_frame>
      <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.&#xD;
  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).&#xD;
  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.</description>
    </other_outcome>
    <other_outcome>
      <measure>Hopefulness (SHS)</measure>
      <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]</time_frame>
      <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.&#xD;
  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).</description>
    </other_outcome>
    <other_outcome>
      <measure>Loneliness (UCLA)</measure>
      <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]</time_frame>
      <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.&#xD;
  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.</description>
    </other_outcome>
    <other_outcome>
      <measure>Engagement with the Purrble intervention (TWEETS)</measure>
      <time_frame>all timepoints following deployment for intervention group [Time frame: Ten times during the 10-week long deployment period (week 4-13)]</time_frame>
      <description>An additional aim includes investigating the engagements with the Purrble over the 10-week deployment period among intervention participants.&#xD;
  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.</description>
    </other_outcome>
    <other_outcome>
      <measure>Engagement with the Purrble intervention</measure>
      <time_frame>all timepoints following deployment for intervention group [Time frame: Ten times during the 10-week long deployment period (week 4-13)]</time_frame>
      <description>An additional aim includes investigating the engagements with the Purrble over the 10-week deployment period among intervention participants.&#xD;
  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.&#xD;
  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?</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">168</enrollment>
    <condition>Emotion Regulation</condition>
    <condition>Self Harm</condition>
    <arm_group>
      <arm_group_label>Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Wait-list control (access to services as usual)</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Purrble intervention</intervention_name>
      <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.&#xD;
  Logic model underlying the intervention:&#xD;
  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.&#xD;
  Level 2: mechanisms that facilitate long-term engagement with the intervention, building on positive subjective experience of Level 1.&#xD;
  Level 3: shift in young peoples' ER practices and implicit beliefs about emotion, after repeated experience of Levels 1-2.&#xD;
  see JMIR Res Protoc 2021;10(11):e28914 (doi: 10.2196/28914)</description>
      <arm_group_label>Intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Currently experiencing self-harmful thoughts (within the last month) Identify as sexual&#xD;
          orientation or gender identity minority (LGBTQ+) Aged 16-25 years Currently living in the&#xD;
          UK at the time of the study Able to read and write in English&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Young people who live outside the UK, are not within the 16-25 year age bracket, and are&#xD;
          not experiencing self-harmful thoughts will not be included in the study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>16 Years</minimum_age>
      <maximum_age>25 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>King's College London</name>
        <address>
          <city>London</city>
          <country>United Kingdom</country>
        </address>
      </facility>
      <contact>
        <last_name>A. Jess Williams, PhD</last_name>
        <phone>020 7848 1988</phone>
        <email>amy_jess.williams@kcl.ac.uk</email>
      </contact>
      <contact_backup>
        <last_name>Petr Slovak, PhD</last_name>
        <phone>020 7848 1988</phone>
        <email>petr.slovak@kcl.ac.uk</email>
      </contact_backup>
      <investigator>
        <last_name>Seonaid Cleare, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
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    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 29, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>LGBTQ</keyword>
    <keyword>Self-harm</keyword>
    <keyword>Emotion regulation</keyword>
    <keyword>Young people</keyword>
    <keyword>RCT</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Self-Injurious Behavior</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06025942
  org study id: RESCM-22/23-34570
  nct id: NCT06025942
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  measure: Emotion regulation (DERS8)
  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]
  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.
  measure: Self-harmful thoughts (SHQ)
  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]
  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.
  measure: Anxiety (GAD7)
  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]
  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.
  measure: Depression (PHQ-9)
  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]
  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.
  measure: Emotion regulation (PMERQ)
  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]
  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.
  measure: Hopefulness (SHS)
  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]
  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).
  measure: Loneliness (UCLA)
  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]
  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.
  measure: Engagement with the Purrble intervention (TWEETS)
  time frame: all timepoints following deployment for intervention group [Time frame: Ten times during the 10-week long deployment period (week 4-13)]
  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.
  measure: Engagement with the Purrble intervention
  time frame: all timepoints following deployment for intervention group [Time frame: Ten times during the 10-week long deployment period (week 4-13)]
  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?
  arm group label: Intervention
  arm group type: Experimental
  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 group label: Control
  arm group type: No Intervention
  description: Wait-list control (access to services as usual)
  intervention type: Behavioral
  intervention name: Purrble 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)
  arm group label: Intervention
  criteria: 
  gender: All
  minimum age: 16 Years
  maximum age: 25 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  contact: 
  contact backup: 
  investigator: 
  country: United Kingdom
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  responsible party type: Sponsor
  mesh term: Self-Injurious Behavior