Clinical trial NCT03732989: Testing Self-regulation Effects of a 'Smart Toy'
Official title: Experimental Study Testing the Self-regulation Effects of a Social Assistive Robot Prototype During Moments of Emotional Stress
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Emotion Regulation
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: Anna Freud National Centre for Children and Families
name: University of California Santa Cruz
name: Committee for Children (USA)
First posted: 2018-11-07
Enrollment: 60
Sex: ALL
Minimum age (years): 7
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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. 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:

1. giving a speech,
2. a calculation task, and
3. 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.

Eligibility criteria: Inclusion Criteria:

* Aged 7-10 years
* Understand English sufficiently to take part and complete study materials

Exclusion Criteria:

* Aged \<7 years or \>10 years
* Does not understand English sufficiently to take part and complete study materials

Primary outcomes:
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
timeFrame: 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
measure: Comparison of change in physiological stress levels between the groups
timeFrame: Continuously from baseline until the end of the experimental session (approximately 1 hour).
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: University College London
Study officials:
affiliation: University College London; Anna Freud National Centre for Children and Families
name: Petr Slovak, PhD
role: PRINCIPAL_INVESTIGATOR
References: