Testing Self-regulation Effects of a 'Smart Toy'

NCT03732989 | Unknown DMC

• 1 other identifier: 3923/005
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Emotion Regulation

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Continuously from baseline until the end of the experimental session (approximately 1 hour).

Study Arms (2)

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).

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).

Device: Interactive toy prototype

Interventions

Interactive toy prototype DEVICE

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).

Experimental: Interactive toy prototype

Non-interactive toy prototype DEVICE

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.

Control group: Non-interactive toy prototype

Eligibility Criteria

• Age: 7 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University College, London: lead
• Anna Freud National Centre for Children and Families: collaborator
• University of California Santa Cruz: collaborator
• Committee for Children (USA): collaborator

Study Sites (1)

University College London

London, WC1E 6BT, United Kingdom

RECRUITING

MeSH Terms

Conditions

Emotional Regulation

Condition Hierarchy (Ancestors)

Self-Control; Social Behavior; Behavior

Study Officials

• Petr Slovak, PhD

  University College London; Anna Freud National Centre for Children and Families

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nikki Theofanopoulou, MSc

CONTACT

07513 218364; nikki.theofanopoulou@annafreud.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not be aware of the other condition, i.e., that the device could be interactive/non-interactive.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2018
• First Posted: November 7, 2018
• Study Start: June 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: June 6, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)