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

NCT04810455 | Unknown

• 1 other identifier: #18-CFC-101
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Emotions

Keywords

emotion regulation; child-led intervention; in-situ intervention

Outcome Measures

Primary Outcomes (1)

• 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.

  Daily, for the 4-week long deployment period

Secondary Outcomes (8)

• Daily parent-report EMA -- child daily mood (mDES)

  Daily, for the 4-week long deployment period

• Daily parent-report EMA -- daily engagement

  Daily, for the 4-week long deployment period

• Daily parent-report EMA -- reaction to triggering events

  Daily, for the 4-week long deployment period

• Weekly questionnaires for parents -- child emotion regulation (SDQ)

  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)

  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.

Other Outcomes (1)

• Post-deployment interviews (process analysis)

  One time, within 2 weeks following the primary data collection period

Study Arms (2)

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.

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.

Other: Active control toy

Interventions

Purrble 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.

Purrble -- Intervention design and logic model

Active control toy 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.

Non-interactive plush toy -- active control group

Eligibility Criteria

• Age: 8 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• King's College London: lead
• Committee for Children: collaborator

Related Publications (1)

• 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.

  PMID: 34751666 DERIVED

MeSH Terms

Conditions

Emotional Regulation

Condition Hierarchy (Ancestors)

Self-Control; Social Behavior; Behavior

Central Study Contacts

Petr Slovak, Dr

CONTACT

+44 020 7848 1988; petr.slovak@kcl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2021
• First Posted: March 23, 2021
• Study Start: March 13, 2021
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2021
• Last Updated: March 23, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share