Ignite Creation Date:
2024-05-06 @ 3:57 PM
Last Modification Date:
2024-10-26 @ 2:00 PM
Study NCT ID:
NCT04810455
Status:
UNKNOWN
Last Update Posted:
2021-03-23
First Post:
2021-03-15
Brief Title:
An In-situ Child-led Intervention To Promote Emotion Regulation Competence in Middle Childhood Protocol For an Exploratory Randomised Control Trial
Sponsor:
Kings College London
Organization:
Kings College London
Study Overview
Official Title:
An In-situ Child-led Intervention To Promote Emotion Regulation Competence in Middle Childhood Protocol For an Exploratory Randomised Control Trial
Status:
UNKNOWN
Status Verified Date:
2021-03
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 childrens emotion regulation routines there is so far no quantitative evidence of the interventions 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 parents 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 childs 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
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 parents 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 childs 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None