Clinical trial NCT04786080: Supporting Parents & Kids Through Lockdown Experiences (SPARKLE).
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Behavior Problem
Mental Health Issue
Keywords: Child Behaviour Problems
Parenting
Smartphone Application
COVID-19 Pandemic
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: University of Oxford
First posted: 2021-03-08
Enrollment: 646
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Strengths and Difficulties Questionnaire (SDQ; Goodman, 1997) Conduct Problems
timeFrame: Measured at one month post-randomisation (T2).
Secondary outcomes:
measure: SDQ Conduct Problems
timeFrame: Measured at two months post-randomisation (T3).
measure: SDQ Emotional Problems
timeFrame: Measured at one (T2) and two months (T3) post-randomisation.
measure: Parental child-related stress and worries levels
timeFrame: Measured at one (T2) and two months (T3) post-randomisation.
measure: Family conflict
timeFrame: Measured at one (T2) and two months (T3) post-randomisation.
measure: Depression, Anxiety and Stress Scale (DASS-21) parental psychological distress
timeFrame: Measured at one (T2) and two months (T3) post-randomisation.
Other outcomes:
measure: Family characteristics and demographic measures
timeFrame: Measured at baseline (T1).
measure: COVID-19 pandemic lockdown circumstances
timeFrame: Measured at baseline (T1), and one (T2) and two months (T3) post-randomisation.
measure: SDQ ADHD Symptoms
timeFrame: Measured at baseline (T1), and one (T2) and two months (T3) post-randomisation.
measure: SDQ Peer Problems
timeFrame: Measured at baseline (T1), and one (T2) and two months (T3) post-randomisation.
measure: SDQ Prosocial Behaviour
timeFrame: Measured at baseline (T1), and one (T2) and two months (T3) post-randomisation.
measure: Estimate of resource use for the health economic analysis
timeFrame: Measured at one (T2) and two months post-randomisation (T3).
measure: Attitudes to Parent Positive
timeFrame: Measured at one (T2) and two months (T3) post-randomisation.
measure: App usage data
timeFrame: Measured at one (T2) and two months (T3) post-randomisation.
measure: Adverse events
timeFrame: Measured at one (T2) and two months (T3) post-randomisation.
Locations:
city: London
country: United Kingdom
facility: King's College London
Study officials:
affiliation: edmund.sonuga-barke@kcl.ac.uk
name: Edmund Sonuga-Barke, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kostyrka-Allchorne K, Creswell C, Byford S, Day C, Goldsmith K, Koch M, Gutierrez WM, Palmer M, Raw J, Robertson O, Shearer J, Shum A, Slovak P, Waite P, Sonuga-Barke EJS. Supporting Parents & Kids Through Lockdown Experiences (SPARKLE): A digital parenting support app implemented in an ongoing general population cohort study during the COVID-19 pandemic: A structured summary of a study protocol for a randomised controlled trial. Trials. 2021 Apr 10;22(1):267. doi: 10.1186/s13063-021-05226-4.