Supporting Parents & Kids Through Lockdown Experiences (SPARKLE): A Parallel Randomised Controlled Trial of a Digital Parenting Support Application Implemented in the General Population During the COVID-19 Pandemic.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 646
- 试验地点
- 1
- 主要终点
- Strengths and Difficulties Questionnaire (SDQ; Goodman, 1997) Conduct Problems
研究概览
简要总结
Throughout the COVID-19 pandemic, reduced access to childcare, money- and health-related worries and extended confinement and social isolation have placed great pressure on many families. There is evidence that many parents in the UK have struggled to manage their children's behaviour. For instance, Co-SPACE, an ongoing UK-wide study led by the University of Oxford, found a significant increase in parents reporting behavioural problems in children and an increase in family-related stress in response to various local and national lockdowns. Co-SPACE has also found up to 70% of parents reported wanting additional support.
The SPARKLE (Supporting Parents and Kids through Lockdown Experiences) study aims to address this pressing need. SPARKLE is a rapid-deployment randomised controlled trial evaluating whether a digital public health parenting intervention can help parents to manage their children's behaviour problems, as impacted by the COVID-19 UK pandemic and lockdowns.
We aim to evaluate whether the negative effects of the pandemic can by reversed by providing parenting advice digitally, using a specially-designed app, Parent Positive. The Parent Positive app will provide advice to parents through animations, delivering messages carefully selected by parents and experts in the field. The messages will be supplemented with practical parenting resources and an opportunity to network with other parents for peer support. The animations are light-hearted, humorous and non-judgmental and are delivered by eight high-profile celebrities who are also parents.
The SPARKLE study will involve 616 Co-SPACE parents, half of whom will receive access to the Parent Positive app and half who won't.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
It is not possible to blind parents enrolled in the study and Qualtrics will automatically inform parents of their group allocation. Blinded members of the research team and the senior statistician will not be given access to the Qualtrics system or the data in order to remain blinded until after the analysis is complete. We do not anticipate any serious harms associated with taking part in the intervention, therefore there will be no need to unblind any blinded staff during the study. The junior statistician will be unblinded throughout.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The Co-SPACE inclusion criteria will apply: participant is willing and able to give informed consent, must be at least 18 years old and lives in the UK.
- •SPARKLE-specific criteria will be: participant (parent/caregiver) has a child aged 4-10 years and has access to a smartphone or tablet with operating system OS 8-9 or higher (Android devices) or iOS 12-13 or higher (Apple devices).
排除标准
- •There will be no exclusion criteria. Participants will not be selected on the basis of pre-existing child conduct problems.
研究组 & 干预措施
Parent Positive
This is an app developed for use on a smartphone providing a flexible digital space where parents can get support and advice to help them manage their children's behaviour. The app will be free and parents will be able to access the information when needed and in the order they choose. Parents in the intervention group will receive access during the immediate post-randomisation period.
干预措施: Parent Positive (Behavioral)
Follow-Up as Usual
FAU was selected as a comparator because of the pragmatic nature of the trial. Individuals randomised to FAU will receive no intervention for the first 10 weeks while the data for baseline (T1), T2 and T3 are collected. They will then be given access to all three zones of the app.
结局指标
主要结局
Strengths and Difficulties Questionnaire (SDQ; Goodman, 1997) Conduct Problems
时间窗: Measured at one month post-randomisation (T2).
Parent-rated conduct subscale of the SDQ; a five item subscale measuring oppositional, defiant and disruptive behaviour rated on a 3-point Likert scale (not true, somewhat true, and certainly true), with a mix of positive and negatively phrased items. Individual items' scores are summed to derive an overall symptoms subscale score. This measure is also collected at baseline (T1), prior to randomisation.
次要结局
- Family conflict(Measured at one (T2) and two months (T3) post-randomisation.)
- SDQ Emotional Problems(Measured at one (T2) and two months (T3) post-randomisation.)
- Parental child-related stress and worries levels(Measured at one (T2) and two months (T3) post-randomisation.)
- SDQ Conduct Problems(Measured at two months post-randomisation (T3).)
- Depression, Anxiety and Stress Scale (DASS-21) parental psychological distress(Measured at one (T2) and two months (T3) post-randomisation.)