Supporting Parents & Kids Through Lockdown Experiences (SPARKLE).

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Mental Health Issue, Child Behavior Problem

Intervention / Treatment
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* Behavioral: Parent Positive


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: There will be no exclusion criteria. Participants will not be selected on the basis of pre-existing child conduct problems.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: SPARKLE is a two-arm superiority parallel group randomised controlled trial (RCT) embedded in an existing large self-selected community cohort - Co-SPACE. Co-SPACE parents aged ≥18, who have children aged 4-10 years, will be invited to take part in the SPARKLE trial. Those who consent to SPARKLE will be randomised 1:1 to either Parent Positive or FAU. Outcome measures will be collected according to the Co-SPACE schedule at baseline (T1), which will be the Co-SPACE survey data obtained immediately prior to randomisation, and then at one month (T2) and two months (T3) post-randomisation.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Parent Positive<br>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. | Behavioral: Parent Positive<br>* Parent Positive is a smartphone app delivering information and parenting support aiming to improve wellbeing within the family and reduce pressures on services given the ongoing pandemic-related challenges. It will consist of three zones, providing: structured advice, support and tips for parents facilitated parent-to-parent communication platform where parents can post questions of one another and parenting experts access to carefully selected high-quality, evidence-based online parenting resources.<br>|
| No Intervention: Follow-Up as Usual<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Strengths and Difficulties Questionnaire (SDQ; Goodman, 1997) Conduct Problems | 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. | Measured at one month post-randomisation (T2). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SDQ Conduct Problems | 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. | Measured at two months post-randomisation (T3). | 
| SDQ Emotional Problems | Parent-rated emotional problems subscale of the SDQ; a five item subscale measuring fearfulness and anxiety rated on a 3-point Likert scale (not true, somewhat true, and certainly true) with positively 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. | Measured at one (T2) and two months (T3) post-randomisation. | 
| Parental child-related stress and worries levels | This is based on five items routinely measured in Co-SPACE regarding children's behaviour, wellbeing, screen time use, education and future using a 4-point Likert scale (not at all, a little, quite a lot, a great deal). Individual questions' scores are summed to generate a single score. This measure is also collected at baseline (T1), prior to randomisation. | Measured at one (T2) and two months (T3) post-randomisation. | 
| Family conflict | This is based on three items routinely collected in Co-SPACE relating to arguments between parents, parents and children and siblings which are measured on a 4-point Likert scale (not at all, a bit, a lot, completely). The three questions are summed to generate a total score. This measure is also collected at baseline (T1), prior to randomisation. | Measured at one (T2) and two months (T3) post-randomisation. | 
| Depression, Anxiety and Stress Scale (DASS-21) parental psychological distress | This is a widely validated 21-item self-report questionnaire measuring adult depression, anxiety and stress. Each of the subscales consists of seven items rated on a 4-point Likert scale (did not apply to me at all; applied to me to some degree, or some of the time; applied to me to a considerable degree, or a good part of the time, applied to me very much, or most of the time), which are summed to obtain a single subscale score. The subscales scores will be summed and multiplied by two to form a single psychological distress measure comparable to the DASS-42 measure. This measure is also collected at baseline (T1), prior to randomisation. | Measured at one (T2) and two months (T3) post-randomisation. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Child Behaviour Problems, Parenting, Smartphone Application, COVID-19 Pandemic