EmotionsNCT04810455
An In-situ, Child-led Intervention To Promote Emotion Regulation Competence in Middle Childhood: Protocol For an Exploratory Randomised Control Trial
A study testing Purrble in people with Emotions, run by King's College London.
Trial summary
The aim of this study is to examine, for the first time, the efficacy of a new intervention model for child-led emotion regulation -Purrble- that could be deployed across prevention and treatment contexts. Read more about this study
- Who is it for?
- Ages 8 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Emotions
- What is being tested?
- Purrble
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 13 Mar 2021to 31 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- child aged 8-10
- parent-reported score of 10 or higher for the total difficulties score on the Strength and Difficulties (SDQ) questionnaire
Who cannot join
- child participating in another mental health intervention
- parent and/or child not fluent in English (as all measurement scales are in English)
Trial locations and contacts
No sites are listed yet.
About this study
The aim of this study is to examine, for the first time, the efficacy of a new intervention model for child-led emotion regulation -Purrble- that could be deployed across prevention and treatment contexts.
Read the detailed description
Background: Emotion regulation is a key transdiagnostic risk factor for a range of psychopathologies, making it a prime target for both prevention and treatment interventions in childhood. Existing interventions predominantly rely on workshop or in-person therapy-based approaches, limiting the ability to promote emotion regulation competence for children in everyday settings and at scale. Purrble is a newly developed, inexpensive socially assistive robot-in the form of an interactive plush toy-which uses haptic feedback to support in-the-moment emotion regulation. It is accessible to children as needed in their daily lives, without the requirement for a priori training. While qualitative data from prior studies show high engagement in-situ and anecdotal evidence of the robot being incorporated into children's emotion regulation routines, there is so far no quantitative evidence of the intervention's impact on child outcomes.
Objective: The aim of this study is to examine, for the first time, the efficacy of a new intervention model for child-led emotion regulation-Purrble-that could be deployed across prevention and treatment contexts.
Methods: A total of 120 children aged 8-10 will be selected from an 'enriched' non-clinical US population: for inclusion, the cutoff for parent's rating of child dysregulation will be 10 points or higher on the total difficulties score on the Strengths and Difficulties Questionnaire. This cutoff selects for a measurable-but not necessarily clinical-level of the child's emotion regulatory difficulties. The selected families will be randomly assigned with .5 probability to receive either Purrble or an active control (non-interactive plush toy). The primary outcome will be a daily EMA measure of child emotion regulation capability (as reported by parents) over a period of 4 weeks. Exploratory analysis will investigate the intervention impact on secondary outcomes of child emotion regulation, collected weekly over the same 4 week period, with follow-ups at 1 month and 6 months post-deployment. Quantitative data will be analysed on an intent-to-treat basis. A proportion of families (~30% of the sample) will be interviewed post-deployment as part of process analysis.
- Conditions
- Emotions
- Being tested
- Purrble, Active control toy
- Keywords
- emotion regulation, child-led intervention, in-situ intervention
- Medical subject headings
- Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PurrbleOther
The objective of this study is to evaluate the impact of having access to the Purrble intervention, compared to an active control in the form of a non-interactive plush toy, on child daily emotion regulation (primary outcome) as well as a range of secondary outcomes over a period of one month.
The investigators hypothesise that engagement with an in-situ, 'bottom-up' emotion regulation intervention which enables in-the-moment soothing for children, will lead to measurable changes in child self-regulatory behaviours over time.
Active control toyOther
The selected active control toy is the Wild Republic 8'' Hedgehog animal. The selection process was guided by: the plush toy needed to have analogous size, weight, quality of materials, and at least similar (if not higher) visual appeal. The investigators also made sure to include the design characteristics our prior work suggested were important for the narrative around the toy. These were selecting a similarly stylised animal (to enable emotion projection and feelings of care), as well as no visible mouth on the toy (to prevent setting an expectation about the toy's emotional state as a mouth would imply an emotional expression). Additionally, the investigators have adapted the one-page parent-facing descriptions of the narrative that come with Purrble also for the active control unit: as such, the active control families will receive the same general narrative-without the explicit mentions of the toy interactivity-and the same suggested activities for parents.
| Study group | Role | What they receive |
|---|---|---|
| Purrble -- Intervention design and logic model | Experimental | The intervention takes the form of an interactive plush toy, designed to be handed over to the child and support in-the-moment soothing; see (Theofanopoulou et al 2019, Slovak et al 2018) for the design and data from previous deployments.
The toy is introduced to the child as an anxious creature that needs kind attention from humans. When picked up, the toy emits a frantic heartbeat that slows down if the child uses calm stroking movements. If the toy 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 children in emotional moments when they would attempt 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 children's ER practices and implicit beliefs about emotion, after repeated experience of Levels 1-2. Receives: Other: Purrble |
| Non-interactive plush toy -- active control group | Active comparator | The investigators argue that a comparison with a non-active control-such as waiting list / treatment-as-usual (i.e., nothing)-would not allow us to distinguish the hypothesised impact on in-the-moment soothing of interactivity vs. the emergence of new family routines; and would be also open to unequal social desirability bias.
However, from the perspective of the hypothesised logic model (Levels 1-3), it is not necessary for the active control to have exactly the same form factor as the active toy, as long as it is comparable in size, shape, and appeal. In fact, the investigators have explicitly decided not to use deactivated Purrble units as active controls due to the increased risk of unblinding, whereby the participants search for or come across Purrble online (or notice the plastic enclosure with electronics inside the toy), and assume their unit is malfunctioning. Receives: Other: Active control toy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived child emotion regulation ability
Composite end-of-day 4-item parent-report measure of the perceived child emotion regulation ability throughout the day. The composite score for each day will be computed as the mean value across the 4 items:
- Today, to what extent was the participant's child able to take difficult things in stride?
- Today, to what extent did the participant's child get easily triggered or upset?
- Today, to what extent was the participant's child able to calm down easily if upset?
- Today, to what extent did the participant's child get very emotional even after the littlest things?
These items were selected as tapping into the proximal emotion regulation behaviour that (a) would be affected if the intervention is effective, (b) directly observable by parents, (c) state-based to enable daily measurement, (d) connected to the intervention theory of change.
Measured: Daily, for the 4-week long deployment period
Secondary outcomes (8)
Daily parent-report EMA -- child daily mood (mDES)
Measured by selected mDES (Fredrickson et al 2003) emotion triplets, balancing 2 negative and 2 positive sets, whilst being informed by prior qualitative studies. The items are listed below, all measured on a visual analogue scale with not at all and extremely as the anchors.
Measured: Daily, for the 4-week long deployment period
Daily parent-report EMA -- daily engagement
Daily engagement item asks about general perception of engagement with the toy ("How much did the participant's child play with the toy today?", measured on a visual analogue scale with <not even once> and <they were inseparable> as the anchors).
Measured: Daily, for the 4-week long deployment period
Daily parent-report EMA -- reaction to triggering events
Series of explorative items examining the child's reaction after potentially triggering events. The investigators will first ask the parents "Did anything happen today that would typically upset the participant's child?". The purpose of these items to gain qualitative understanding of the toys' use around challenging situations and to guide post-deployment interviews.
Measured: Daily, for the 4-week long deployment period
Weekly questionnaires for parents -- child emotion regulation (SDQ)
These include parent reports on distal outcomes of parent-reported emotional and behavioural difficulties of the child will be measured by the 25-item Strength and Difficulties Questionnaire (SDQ).
Measured: at baseline (just before intervention/control toys are delivered); and then weekly for a period of one month (end of week 1, week 2, week 3, week 4); and then at 1-month and 6-month follow-up.
Weekly questionnaires for parents -- child emotion regulation (ERC)
These include parent reports on distal outcomes of parent-reported emotion regulation lability and competence will be measured by the 24-item Emotion Regulation Checklist (ERC) questionnaire.
Measured: at baseline (just before intervention/control toys are delivered); and then weekly for a period of one month (end of week 1, week 2, week 3, week 4); and then at 1-month and 6-month follow-up.
Weekly questionnaires for parents -- engagement (TWEETS)
Parent-reported behavioural, cognitive, and affective engagement with the intervention will be measured by an adapted version of the TWEETS questionnaire, a new, promising instrument specifically designed to measure engagement with digital mental health interventions, with good reliability in prior studies.
Measured: weekly for a period of one month (end of week 1, week 2, week 3, week 4); and then at 1-month and 6-month follow-up.
Weekly questionnaires for children (DERS)
Child-reported emotion dysregulation will be measured by a shortened version of Brief Difficulties in Emotion Regulation Scale (DERS), following prior work with children of similar ages (Schneider et al 2020). DERS has been developed to measure clinically relevant difficulties in emotion regulation, across 6 factor-analytically-derived subscales. The DERS questionnaire has been used extensively to facilitate understanding of how emotion dysregulation is associated with psychiatric symptoms, and to measure treatment progress.
Measured: 5 data points collected: at baseline, and end of week 1, week 2, week 3 and week 4
Weekly questionnaires for children (ER beliefs)
Child-reported beliefs about emotion regulation will be measured by an adapted ER beliefs questionnaire (Ford et al 2017), asking children to pick one out of four statements (e.g., "I cannot control my feelings at all"; "I can control my feelings a little"; "I can control my feelings a lot"; I can control my feelings all the time") rather using the original Likert scale statements asking about agreement.
Measured: 5 data points collected: at baseline, and end of week 1, week 2, week 3 and week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start13 Mar 2021 (estimated)
- Primary completion31 May 2021 (estimated)
- Study completion31 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EmotionsStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Committee for Children
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04810455
- Sponsor's protocol ID
- #18-CFC-101
- Status last verified
- Mar 2021
- First submitted
- 15 Mar 2021
- Last updated
- 23 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Slovak P, Ford BQ, Widen S, Dauden Roquet C, Theofanopoulou N, Gross JJ, Hankin B, Klasnja P. An In Situ, Child-Led Intervention to Promote Emotion Regulation Competence in Middle Childhood: Protocol for an Exploratory Randomized Controlled Trial. JMIR Res Protoc. 2021 Nov 9;10(11):e28914. doi: 10.2196/28914.
PubMed 34751666
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An In-situ, Child-led Intervention To Promote Emotion Regulation Competence in Middle Childhood: Protocol For an Exploratory Randomised Control Trial
- ClinicalTrials.gov ID
- NCT04810455
- Acronym / sponsor ID
- #18-CFC-101
- Conditions
- Emotions
- Keywords
- emotion regulation, child-led intervention, in-situ intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Committee for Children
- Study start
- 13 Mar 2021 (estimated)
- Primary completion
- 31 May 2021 (estimated)
- Study completion
- 31 May 2021 (estimated)
- First posted
- 23 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to examine, for the first time, the efficacy of a new intervention model for child-led emotion regulation -Purrble- that could be deployed across prevention and treatment contexts.
Detailed description
Background: Emotion regulation is a key transdiagnostic risk factor for a range of psychopathologies, making it a prime target for both prevention and treatment interventions in childhood. Existing interventions predominantly rely on workshop or in-person therapy-based approaches, limiting the ability to promote emotion regulation competence for children in everyday settings and at scale. Purrble is a newly developed, inexpensive socially assistive robot-in the form of an interactive plush toy-which uses haptic feedback to support in-the-moment emotion regulation. It is accessible to children as needed in their daily lives, without the requirement for a priori training. While qualitative data from prior studies show high engagement in-situ and anecdotal evidence of the robot being incorporated into children's emotion regulation routines, there is so far no quantitative evidence of the intervention's impact on child outcomes.
Objective: The aim of this study is to examine, for the first time, the efficacy of a new intervention model for child-led emotion regulation-Purrble-that could be deployed across prevention and treatment contexts.
Methods: A total of 120 children aged 8-10 will be selected from an 'enriched' non-clinical US population: for inclusion, the cutoff for parent's rating of child dysregulation will be 10 points or higher on the total difficulties score on the Strengths and Difficulties Questionnaire. This cutoff selects for a measurable-but not necessarily clinical-level of the child's emotion regulatory difficulties. The selected families will be randomly assigned with .5 probability to receive either Purrble or an active control (non-interactive plush toy). The primary outcome will be a daily EMA measure of child emotion regulation capability (as reported by parents) over a period of 4 weeks. Exploratory analysis will investigate the intervention impact on secondary outcomes of child emotion regulation, collected weekly over the same 4 week period, with follow-ups at 1 month and 6 months post-deployment. Quantitative data will be analysed on an intent-to-treat basis. A proportion of families (~30% of the sample) will be interviewed post-deployment as part of process analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Purrble -- Intervention design and logic model | Experimental | Other: PurrbleThe intervention takes the form of an interactive plush toy, designed to be handed over to the child and support in-the-moment soothing; see (Theofanopoulou et al 2019, Slovak et al 2018) for the design and data from previous deployments. The toy is introduced to the child as an anxious creature that needs kind attention from humans. When picked up, the toy emits a frantic heartbeat that slows down if the child uses calm stroking movements. If the toy 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 children in emotional moments when they would attempt 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 children's ER practices and implicit beliefs about emotion, after repeated experience of Levels 1-2. |
| Non-interactive plush toy -- active control group | Active comparator | Other: Active control toyThe investigators argue that a comparison with a non-active control-such as waiting list / treatment-as-usual (i.e., nothing)-would not allow us to distinguish the hypothesised impact on in-the-moment soothing of interactivity vs. the emergence of new family routines; and would be also open to unequal social desirability bias. However, from the perspective of the hypothesised logic model (Levels 1-3), it is not necessary for the active control to have exactly the same form factor as the active toy, as long as it is comparable in size, shape, and appeal. In fact, the investigators have explicitly decided not to use deactivated Purrble units as active controls due to the increased risk of unblinding, whereby the participants search for or come across Purrble online (or notice the plastic enclosure with electronics inside the toy), and assume their unit is malfunctioning. |
Who may qualify
- Ages
- 8 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- child aged 8-10
- parent-reported score of 10 or higher for the total difficulties score on the Strength and Difficulties (SDQ) questionnaire
Key exclusion criteria (2 listed)
- child participating in another mental health intervention
- parent and/or child not fluent in English (as all measurement scales are in English)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PurrbleThe objective of this study is to evaluate the impact of having access to the Purrble intervention, compared to an active control in the form of a non-interactive plush toy, on child daily emotion regulation (primary outcome) as well as a range of secondary outcomes over a period of one month. The investigators hypothesise that engagement with an in-situ, 'bottom-up' emotion regulation intervention which enables in-the-moment soothing for children, will lead to measurable changes in child self-regulatory behaviours over time. | Other | Purrble -- Intervention design and logic model |
| Active control toyThe selected active control toy is the Wild Republic 8'' Hedgehog animal. The selection process was guided by: the plush toy needed to have analogous size, weight, quality of materials, and at least similar (if not higher) visual appeal. The investigators also made sure to include the design characteristics our prior work suggested were important for the narrative around the toy. These were selecting a similarly stylised animal (to enable emotion projection and feelings of care), as well as no visible mouth on the toy (to prevent setting an expectation about the toy's emotional state as a mouth would imply an emotional expression). Additionally, the investigators have adapted the one-page parent-facing descriptions of the narrative that come with Purrble also for the active control unit: as such, the active control families will receive the same general narrative-without the explicit mentions of the toy interactivity-and the same suggested activities for parents. | Other | Non-interactive plush toy -- active control group |
Primary outcome
Perceived child emotion regulation ability
Time frame: Daily, for the 4-week long deployment period
Composite end-of-day 4-item parent-report measure of the perceived child emotion regulation ability throughout the day. The composite score for each day will be computed as the mean value across the 4 items: * Today, to what extent was the participant's child able to take difficult things in stride? * Today, to what extent did the participant's child get easily triggered or upset? * Today, to what extent was the participant's child able to calm down easily if upset? * Today, to what extent did the participant's child get very emotional even after the littlest things? These items were selected as tapping into the proximal emotion regulation behaviour that (a) would be affected if the intervention is effective, (b) directly observable by parents, (c) state-based to enable daily measurement, (d) connected to the intervention theory of change.
8 secondary outcomes
Daily parent-report EMA -- child daily mood (mDES)
Time frame: Daily, for the 4-week long deployment period
Daily parent-report EMA -- daily engagement
Time frame: Daily, for the 4-week long deployment period
Daily parent-report EMA -- reaction to triggering events
Time frame: Daily, for the 4-week long deployment period
Weekly questionnaires for parents -- child emotion regulation (SDQ)
Time frame: at baseline (just before intervention/control toys are delivered); and then weekly for a period of one month (end of week 1, week 2, week 3, week 4); and then at 1-month and 6-month follow-up.
Weekly questionnaires for parents -- child emotion regulation (ERC)
Time frame: at baseline (just before intervention/control toys are delivered); and then weekly for a period of one month (end of week 1, week 2, week 3, week 4); and then at 1-month and 6-month follow-up.
Weekly questionnaires for parents -- engagement (TWEETS)
Time frame: weekly for a period of one month (end of week 1, week 2, week 3, week 4); and then at 1-month and 6-month follow-up.
Weekly questionnaires for children (DERS)
Time frame: 5 data points collected: at baseline, and end of week 1, week 2, week 3 and week 4
Weekly questionnaires for children (ER beliefs)
Time frame: 5 data points collected: at baseline, and end of week 1, week 2, week 3 and week 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2021.
- Derived from this study: PubMed 34751666Slovak P, Ford BQ, Widen S, Dauden Roquet C, Theofanopoulou N, Gross JJ, Hankin B, Klasnja P. An In Situ, Child-Led Intervention to Promote Emotion Regulation Competence in Middle Childhood: Protocol for an Exploratory Randomized Controlled Trial. JMIR Res Protoc. 2021 Nov 9;10(11):e28914. doi: 10.2196/28914.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Purrble in people with Emotions, run by King's College London.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Petr Slovak, Dr (+44 020 7848 1988, petr.slovak@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived child emotion regulation ability (time frame: Daily, for the 4-week long deployment period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04810455, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2021.