An In-situ, Child-led Intervention To Promote Emotion Regulation Competence in Middle Childhood: Protocol For an Exploratory Randomised Control Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 主要终点
- Perceived child emotion regulation ability
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 8 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •child aged 8-10
- •parent-reported score of 10 or higher for the total difficulties score on the Strength and Difficulties (SDQ) questionnaire
排除标准
- •child participating in another mental health intervention
- •parent and/or child not fluent in English (as all measurement scales are in English)
研究组 & 干预措施
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.
干预措施: Purrble (Other)
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.
干预措施: Active control toy (Other)
结局指标
主要结局
Perceived child emotion regulation ability
时间窗: Daily, for the 4-week long deployment period
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.
次要结局
- Daily parent-report EMA -- child daily mood (mDES)(Daily, for the 4-week long deployment period)
- Weekly questionnaires for children (ER beliefs)(5 data points collected: at baseline, and end of week 1, week 2, week 3 and week 4)
- 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 -- engagement (TWEETS)(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 children (DERS)(5 data points collected: at baseline, and end of week 1, week 2, week 3 and week 4)
- 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.)