Emotion RegulationNCT03732989
Testing Self-regulation Effects of a 'Smart Toy'
A study testing Interactive toy prototype and Non-interactive toy prototype in people with Emotion Regulation, run by University College, London at 1 site in United Kingdom.
Trial summary
The present experimental study aims to explore the effect of an interactive smart toy on children's stress modulation during a stressful experience compared to a non-interactive prototype. Read more about this study
- Who is it for?
- Ages 7 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Emotion Regulation
- What is being tested?
- Interactive toy prototype and Non-interactive toy prototype
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2019to Dec 2019
- 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 7 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Aged 7-10 years
- Understand English sufficiently to take part and complete study materials
Who cannot join
- Aged <7 years or >10 years
- Does not understand English sufficiently to take part and complete study materials
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University College London
London, WC1E 6BT
Nikki Theofanopoulou, 07513 218364, nikki.theofanopoulou@annafreud.org
About this study
Official title: Experimental Study Testing the Self-regulation Effects of a Social Assistive Robot Prototype During Moments of Emotional Stress
The present experimental study aims to explore the effect of an interactive smart toy on children's stress modulation during a stressful experience compared to a non-interactive prototype. It is expected that children given the interactive prototype will experience faster and more effective stress modulation, in comparison to those being given the non-interactive prototype.
These findings will complement the ecologically valid data from week-long at-home deployments of the interactive prototype with families with low socioeconomic status.
Read the detailed description
The proposed experimental design relies on an established task that can induce a short-term stress response to enable us to the test of efficacy of the smart toy in helping children regulate their emotions in controlled settings. The investigators will use an adapted version of the well-established Trier Social Stress Test for Children (TSST-C). The TSST-C was chosen as it is one of the most popular and standardised methods to induce a strong psychosocial stress response in experimental settings, due to its socio-evaluative character and uncontrollability. Prior literature shows that (i) the TSST-C is suitable for children in our age range; and (ii) stress returns to normal levels shortly after children receive positive feedback from the experimenters.
The original TSST-C protocol consists of a preparation period, public speaking task and mental arithmetic task. The investigators have chosen to only use the preparation period, public speaking task and anticipation of the mental arithmetic task as stressors, as pilots suggest that these suffice to elicit a strong-enough stress response that will allow us to test the toy's efficacy; and it would be unethical to subject children to unnecessary tasks.
== Study protocol: ==
On arrival to the room where the experiment will take place, children in both groups will be informed that there are three tasks involved in the study:
- giving a speech,
- a calculation task, and
- helping a newly discovered creature (the toy) which appears to be anxious calm down.
The children will then be fitted with the Empatica E4 wristband which will continuously and non-intrusively monitor their heart rate and skin conductance, and introduced to the toy in order to limit the impact of the novelty effect associated with it. Participants in the control group will be asked to imagine that the toy is a creature which is anxious, while participants in the experimental group will also be told that the creature's heartbeat is fast when it is anxious and slows down when it calms down. The researcher will demonstrate three soothing interactions with the toy (cuddling, stroking, and slow breathing) for 30 seconds and then give the children the toy for 1 minute, after which it will be returned to the researcher.
Following this introduction, participants will stay in the room for 10 minutes reading pictures books if they would like to in order to establish baseline stress levels. After 10 minutes have passed, the researcher will administer the state anxiety scale of the State Trait Anxiety Inventory for Children (STAI-CH).
Participants will then hear the beginning of a story and will be asked to finish it in a manner as exciting as possible in front of a microphone and a camera. Participants will be told that other study participants will do the same and will be prompted to perform better than them, even though in reality they will not be judged for their performance. Participants will remain in the room for 5 minutes preparing their story.
After the preparation period the researcher will administer the state anxiety scale for the second time. Following this, participants will be asked to stand in front of the microphone, the camera and the researcher, and finish the story as excitingly as possible in 3 minutes. If the participant finishes the story in less than 3 minutes, the researcher will ask them to continue in a friendly, supportive manner for a maximum of 3 times, using lines like "You are doing very well. You have to continue for a little bit longer, there is still more time to say your story."
After the speech task is completed the researcher will administer the state anxiety scale for the third time. Following this, the researcher will tell participants that it is time for the calculation task, which will supposedly be asking them to mentally subtract by 7's from a three-digit number. After saying this, the researcher will pretend that there are some issues with the camera that need to be fixed before they can start, and that they will have to shift the order of the two remaining tasks so that they have more time to fix the camera. At this point children will be exposed to one of the two conditions (interactive or non-interactive toy) for 5 minutes, following which they will complete the state anxiety scale for the final time.
The researcher will then tell children that due to the technical issues and time constraints they will not have to do the calculation task, but can rather move on to the last part of the study which is a 10-minute debriefing and feedback session. Every child will be told that they performed extremely well and that the experimenters pretended that they competing with the other participants to induce competitive conditions. The debriefing session will include a manipulation check (how stressfully the experienced the preparation period, speech task and anticipation of mental arithmetic task period) and a short interview about their experience, which will be audio-recorded.
At the end of the procedure, children will be allowed to relax in the room for 15 minutes. The researcher will suggest that they play with the interactive toy; sit down and take deep breaths; listen to guided mindfulness sessions; or read one of the age-appropriate books in the room.
- Conditions
- Emotion Regulation
- Being tested
- Interactive toy prototype, Non-interactive toy prototype
- Medical subject headings
- Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive toy prototypeDevice
The interactive toy prototype takes the form of a hand-crafted plush toy, which was designed to support in-the-moment calming down strategies. The interaction relies on a number of sensors embedded in the 'creature' that register haptic interactions with the toy. In addition, a small vibration motor is used to indicate the creature's state by mimicking a frantic 'heartbeat'. If the creature is calming down in response to the child's touching of the sensors, the heartbeat slows down and eventually turns into happy purring (cf. paper linked below for more details about the design process).
Non-interactive toy prototypeDevice
This toy is the same as the interactive one, but with the interactivity features (haptic feedback) turned off so that it looks and feels like a regular, hand-crafted plush toy.
| Study group | Role | What they receive |
|---|---|---|
| Control group: Non-interactive toy prototype | Active comparator | 30 children will be given the same toy as participants in the experimental group, but without the interactive features (haptic feedback). Receives: Device: Non-interactive toy prototype |
| Experimental: Interactive toy prototype | Experimental | 30 children will be given the same toy as participants in the control group, but with the interactive features (haptic feedback). Receives: Device: Interactive toy prototype |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of change in scores on the State Anxiety subscale of the State-Trait Anxiety Inventory for Children (STAI-CH; Spielberger, 1973) between the groups
The STAI-CH is a widely used instrument for measuring anxiety in children. The state subscale consists of 20 items which measure anxiety as a fleeting emotional state. Each STAI-CH item is a 3-point rating scale for which values of 1, 2, or 3 are assigned for each of the three alternative choices. Thus, scores on the subscale can range from a minimum of 20 to a maximum score of 60. Higher scores indicate greater anxiety.
Measured: 4 timepoints during a single study visit: (i) baseline ; (ii) right before participants are asked to perform the speech task; (iii) right after the speech task; and (iv) right after the 5-minute exposure to one of the two conditions
Comparison of change in physiological stress levels between the groups
Physiological stress reactivity will be measured by an Empatica E4 wristband which will continuously and non-intrusively monitor participants' heart rate and electrodermal activity throughout the experimental session. The change in physiological stress levels between the preparation for the speech task and post-exposure to one of the two conditions will be compared between the two participant groups.
Measured: Continuously from baseline until the end of the experimental session (approximately 1 hour).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2018
- Study startJun 2019 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotion RegulationStudies of the same condition, open and under way.
- More trials run by University 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Anna Freud National Centre for Children and Families, University of California Santa Cruz, Committee for Children (USA)
- Responsible party
- Sponsor
- Investigators
- Petr Slovak, PhD, Principal investigator, University College London; Anna Freud National Centre for Children and Families
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03732989
- Sponsor's protocol ID
- 3923/005
- Status last verified
- Jun 2019
- First submitted
- 2 Oct 2018
- Last updated
- 6 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experimental Study Testing the Self-regulation Effects of a Social Assistive Robot Prototype During Moments of Emotional Stress
- ClinicalTrials.gov ID
- NCT03732989
- Acronym / sponsor ID
- 3923/005
- Conditions
- Emotion Regulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- Anna Freud National Centre for Children and Families, University of California Santa Cruz, Committee for Children (USA)
- Study start
- Jun 2019 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 7 Nov 2018 (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 present experimental study aims to explore the effect of an interactive smart toy on children's stress modulation during a stressful experience compared to a non-interactive prototype. It is expected that children given the interactive prototype will experience faster and more effective stress modulation, in comparison to those being given the non-interactive prototype.
These findings will complement the ecologically valid data from week-long at-home deployments of the interactive prototype with families with low socioeconomic status.
Detailed description
The proposed experimental design relies on an established task that can induce a short-term stress response to enable us to the test of efficacy of the smart toy in helping children regulate their emotions in controlled settings. The investigators will use an adapted version of the well-established Trier Social Stress Test for Children (TSST-C). The TSST-C was chosen as it is one of the most popular and standardised methods to induce a strong psychosocial stress response in experimental settings, due to its socio-evaluative character and uncontrollability. Prior literature shows that (i) the TSST-C is suitable for children in our age range; and (ii) stress returns to normal levels shortly after children receive positive feedback from the experimenters.
The original TSST-C protocol consists of a preparation period, public speaking task and mental arithmetic task. The investigators have chosen to only use the preparation period, public speaking task and anticipation of the mental arithmetic task as stressors, as pilots suggest that these suffice to elicit a strong-enough stress response that will allow us to test the toy's efficacy; and it would be unethical to subject children to unnecessary tasks.
== Study protocol: ==
On arrival to the room where the experiment will take place, children in both groups will be informed that there are three tasks involved in the study:
- giving a speech,
- a calculation task, and
- helping a newly discovered creature (the toy) which appears to be anxious calm down.
The children will then be fitted with the Empatica E4 wristband which will continuously and non-intrusively monitor their heart rate and skin conductance, and introduced to the toy in order to limit the impact of the novelty effect associated with it. Participants in the control group will be asked to imagine that the toy is a creature which is anxious, while participants in the experimental group will also be told that the creature's heartbeat is fast when it is anxious and slows down when it calms down. The researcher will demonstrate three soothing interactions with the toy (cuddling, stroking, and slow breathing) for 30 seconds and then give the children the toy for 1 minute, after which it will be returned to the researcher.
Following this introduction, participants will stay in the room for 10 minutes reading pictures books if they would like to in order to establish baseline stress levels. After 10 minutes have passed, the researcher will administer the state anxiety scale of the State Trait Anxiety Inventory for Children (STAI-CH).
Participants will then hear the beginning of a story and will be asked to finish it in a manner as exciting as possible in front of a microphone and a camera. Participants will be told that other study participants will do the same and will be prompted to perform better than them, even though in reality they will not be judged for their performance. Participants will remain in the room for 5 minutes preparing their story.
After the preparation period the researcher will administer the state anxiety scale for the second time. Following this, participants will be asked to stand in front of the microphone, the camera and the researcher, and finish the story as excitingly as possible in 3 minutes. If the participant finishes the story in less than 3 minutes, the researcher will ask them to continue in a friendly, supportive manner for a maximum of 3 times, using lines like "You are doing very well. You have to continue for a little bit longer, there is still more time to say your story."
After the speech task is completed the researcher will administer the state anxiety scale for the third time. Following this, the researcher will tell participants that it is time for the calculation task, which will supposedly be asking them to mentally subtract by 7's from a three-digit number. After saying this, the researcher will pretend that there are some issues with the camera that need to be fixed before they can start, and that they will have to shift the order of the two remaining tasks so that they have more time to fix the camera. At this point children will be exposed to one of the two conditions (interactive or non-interactive toy) for 5 minutes, following which they will complete the state anxiety scale for the final time.
The researcher will then tell children that due to the technical issues and time constraints they will not have to do the calculation task, but can rather move on to the last part of the study which is a 10-minute debriefing and feedback session. Every child will be told that they performed extremely well and that the experimenters pretended that they competing with the other participants to induce competitive conditions. The debriefing session will include a manipulation check (how stressfully the experienced the preparation period, speech task and anticipation of mental arithmetic task period) and a short interview about their experience, which will be audio-recorded.
At the end of the procedure, children will be allowed to relax in the room for 15 minutes. The researcher will suggest that they play with the interactive toy; sit down and take deep breaths; listen to guided mindfulness sessions; or read one of the age-appropriate books in the room.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group: Non-interactive toy prototype | Active comparator | Device: Non-interactive toy prototype30 children will be given the same toy as participants in the experimental group, but without the interactive features (haptic feedback). |
| Experimental: Interactive toy prototype | Experimental | Device: Interactive toy prototype30 children will be given the same toy as participants in the control group, but with the interactive features (haptic feedback). |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Aged 7-10 years
- Understand English sufficiently to take part and complete study materials
Key exclusion criteria (2 listed)
- Aged <7 years or >10 years
- Does not understand English sufficiently to take part and complete study materials
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 |
|---|---|---|
| Interactive toy prototypeThe interactive toy prototype takes the form of a hand-crafted plush toy, which was designed to support in-the-moment calming down strategies. The interaction relies on a number of sensors embedded in the 'creature' that register haptic interactions with the toy. In addition, a small vibration motor is used to indicate the creature's state by mimicking a frantic 'heartbeat'. If the creature is calming down in response to the child's touching of the sensors, the heartbeat slows down and eventually turns into happy purring (cf. paper linked below for more details about the design process). | Device | Experimental: Interactive toy prototype |
| Non-interactive toy prototypeThis toy is the same as the interactive one, but with the interactivity features (haptic feedback) turned off so that it looks and feels like a regular, hand-crafted plush toy. | Device | Control group: Non-interactive toy prototype |
Primary outcome
Comparison of change in scores on the State Anxiety subscale of the State-Trait Anxiety Inventory for Children (STAI-CH; Spielberger, 1973) between the groups
Time frame: 4 timepoints during a single study visit: (i) baseline ; (ii) right before participants are asked to perform the speech task; (iii) right after the speech task; and (iv) right after the 5-minute exposure to one of the two conditions
The STAI-CH is a widely used instrument for measuring anxiety in children. The state subscale consists of 20 items which measure anxiety as a fleeting emotional state. Each STAI-CH item is a 3-point rating scale for which values of 1, 2, or 3 are assigned for each of the three alternative choices. Thus, scores on the subscale can range from a minimum of 20 to a maximum score of 60. Higher scores indicate greater anxiety.
Comparison of change in physiological stress levels between the groups
Time frame: Continuously from baseline until the end of the experimental session (approximately 1 hour).
Physiological stress reactivity will be measured by an Empatica E4 wristband which will continuously and non-intrusively monitor participants' heart rate and electrodermal activity throughout the experimental session. The change in physiological stress levels between the preparation for the speech task and post-exposure to one of the two conditions will be compared between the two participant groups.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2019.
- 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.
Petr Slovak, PhD principal investigator
University College London; Anna Freud National Centre for Children and Families
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interactive toy prototype and Non-interactive toy prototype in people with Emotion Regulation, run by University College, London at 1 site in United Kingdom.
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 6 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Nikki Theofanopoulou, MSc (07513 218364, nikki.theofanopoulou@annafreud.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of change in scores on the State Anxiety subscale of the State-Trait Anxiety Inventory for Children (STAI-CH; Spielberger, 1973) between the groups (time frame: 4 timepoints during a single study visit: (i) baseline ; (ii) right before participants are asked to perform the speech task; (iii) right after the speech task; and (iv) right after the 5-minute exposure to one of the two conditions). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jun 2019.