Clinical trial NCT04810455: An In-situ, Child-led Intervention To Promote Emotion Regulation Competence in Middle Childhood: Protocol For an Exploratory Randomised Control Trial
Official title: An In-situ, Child-led Intervention To Promote Emotion Regulation Competence in Middle Childhood: Protocol For an Exploratory Randomised Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Emotions
Keywords: emotion regulation
child-led intervention
in-situ intervention
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: Committee for Children
First posted: 2021-03-23
Enrollment: 120
Sex: ALL
Minimum age (years): 8
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Perceived child emotion regulation ability
timeFrame: Daily, for the 4-week long deployment period
Secondary outcomes:
measure: Daily parent-report EMA -- child daily mood (mDES)
timeFrame: Daily, for the 4-week long deployment period
measure: Daily parent-report EMA -- daily engagement
timeFrame: Daily, for the 4-week long deployment period
measure: Daily parent-report EMA -- reaction to triggering events
timeFrame: Daily, for the 4-week long deployment period
measure: Weekly questionnaires for parents -- child emotion regulation (SDQ)
timeFrame: 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.
measure: Weekly questionnaires for parents -- child emotion regulation (ERC)
timeFrame: 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.
measure: Weekly questionnaires for parents -- engagement (TWEETS)
timeFrame: 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.
measure: Weekly questionnaires for children (DERS)
timeFrame: 5 data points collected: at baseline, and end of week 1, week 2, week 3 and week 4
measure: Weekly questionnaires for children (ER beliefs)
timeFrame: 5 data points collected: at baseline, and end of week 1, week 2, week 3 and week 4
Other outcomes:
measure: Post-deployment interviews (process analysis)
timeFrame: One time, within 2 weeks following the primary data collection period
Locations:
Study officials:
References:
citation: 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.