An In-situ, Child-led Intervention To Promote Emotion Regulation Competence in Middle Childhood: Protocol For an Exploratory Randomised Control Trial

NCT ID: NCT04810455

Last Updated: 2021-03-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-13
• Study Completion Date: 2021-05-31

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Purrble -- Intervention design and logic model

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.

Group Type: EXPERIMENTAL

Purrble

Intervention Type: OTHER

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.

Non-interactive plush toy -- active control group

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.

Group Type: ACTIVE_COMPARATOR

Active control toy

Intervention Type: OTHER

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.

Interventions

Purrble

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.

Intervention Type: OTHER

Active control toy

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• child aged 8-10
• parent-reported score of 10 or higher for the total difficulties score on the Strength and Difficulties (SDQ) questionnaire

Exclusion Criteria

• child participating in another mental health intervention
• parent and/or child not fluent in English (as all measurement scales are in English)

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Committee for Children

UNKNOWN

Sponsor Role: collaborator

King's College London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Petr Slovak, Dr

Role: CONTACT

petr.slovak@kcl.ac.uk

+44 020 7848 1988

References

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.

Reference Type: DERIVED

PMID: 34751666 (View on PubMed)

Other Identifiers

#18-CFC-101

Identifier Type: -

Identifier Source: org_study_id