Supporting Parents & Kids Through Lockdown Experiences (SPARKLE).

NCT04786080 | Completed

• 1 other identifier: SPARKLE; REC #:HR-20/21-21451
• Study Type: interventional
• Target: 646
• Locations: 1 country
• Sites: 1

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.

Conditions

Child Behavior Problem; Mental Health Issue

Keywords

Child Behaviour Problems; Parenting; Smartphone Application; COVID-19 Pandemic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• SDQ Conduct Problems

  Measured at two months post-randomisation (T3).

• 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.

• Family conflict

  Measured at one (T2) and two months (T3) post-randomisation.

• Depression, Anxiety and Stress Scale (DASS-21) parental psychological distress

  Measured at one (T2) and two months (T3) post-randomisation.

Other Outcomes (9)

• Family characteristics and demographic measures

  Measured at baseline (T1).

• COVID-19 pandemic lockdown circumstances

  Measured at baseline (T1), and one (T2) and two months (T3) post-randomisation.

• SDQ ADHD Symptoms

  Measured at baseline (T1), and one (T2) and two months (T3) post-randomisation.

Study Arms (2)

Parent Positive

EXPERIMENTAL

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

Follow-Up as Usual

NO INTERVENTION

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.

Interventions

Parent Positive BEHAVIORAL

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: 1. structured advice, support and tips for parents 2. facilitated parent-to-parent communication platform where parents can post questions of one another and parenting experts 3. access to carefully selected high-quality, evidence-based online parenting resources.

Parent Positive

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

Sponsors & Collaborators

• King's College London: lead
• University of Oxford: collaborator

Study Sites (1)

King's College London

London, United Kingdom

Location

Related Publications (3)

• Pokorna N, Palmer M, Pearson O, Beckley-Hoelscher N, Shearer J, Kostyrka-Allchorne K, Robertson O, Koch M, Slovak P, Day C, Byford S, Waite P, Creswell C, Sonuga-Barke EJS, Goldsmith K. Moderators of the Effects of a Digital Parenting Intervention on Child Conduct and Emotional Problems Implemented During the COVID-19 Pandemic: Results From a Secondary Analysis of Data From the Supporting Parents and Kids Through Lockdown Experiences (SPARKLE) Randomized Controlled Trial. JMIR Pediatr Parent. 2024 Oct 8;7:e53864. doi: 10.2196/53864.

  PMID: 39378100 DERIVED

• Palmer M, Beckley-Hoelscher N, Shearer J, Kostyrka-Allchorne K, Robertson O, Koch M, Pearson O, Slovak P, Day C, Byford S, Goldsmith K, Waite P, Creswell C, Sonuga-Barke EJS. The Effectiveness and Cost-Effectiveness of a Universal Digital Parenting Intervention Designed and Implemented During the COVID-19 Pandemic: Evidence From a Rapid-Implementation Randomized Controlled Trial Within a Cohort. J Med Internet Res. 2023 Jul 27;25:e44079. doi: 10.2196/44079.

  PMID: 37498669 DERIVED

• 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.

  PMID: 33838678 DERIVED

Related Links

• KCL SPARKLE Study press release
• University of Oxford Co-SPACE website

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Edmund Sonuga-Barke, PhD

  edmund.sonuga-barke@kcl.ac.uk

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 24, 2021
• First Posted: March 8, 2021
• Study Start: May 19, 2021
• Primary Completion: October 10, 2021
• Study Completion: January 5, 2022
• Last Updated: August 4, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be made publicly accessible on publication of research findings or no later than 12 months after the completion of the grant, whichever is sooner.
• Access Criteria: The data will be deposited with the UK Data Service or another suitable repository and will therefore be made publicly and freely accessible.

Locations

GB (1)