- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04786080
Supporting Parents & Kids Through Lockdown Experiences (SPARKLE). (SPARKLE)
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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
London, United Kingdom
- King's College London
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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:
|
No Intervention: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Strengths and Difficulties Questionnaire (SDQ; Goodman, 1997) Conduct Problems
Time Frame: 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.
|
Measured at one month post-randomisation (T2).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
SDQ Conduct Problems
Time Frame: Measured at two months post-randomisation (T3).
|
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
Time Frame: Measured at one (T2) and two months (T3) post-randomisation.
|
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
Time Frame: Measured at one (T2) and two months (T3) post-randomisation.
|
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
Time Frame: Measured at one (T2) and two months (T3) post-randomisation.
|
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
Time Frame: Measured at one (T2) and two months (T3) post-randomisation.
|
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.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Family characteristics and demographic measures
Time Frame: Measured at baseline (T1).
|
Parents will provide information about their child's age and gender, their own and their child's ethnicity, number of children in the family, number of rooms in the family home and access to outside space.
This will be used for description of the sample.
We will estimate family SES based on total household income, coded as < £16,000 | £16,000 - £29,999 | £30,000 - £59,999 | £60,000 - £89,999 | £90,000 - £119,999 | > £120,000 | Prefer not to say, likely collapsing small categories.
Family characteristics and demographic measures are obtained for sample description and for moderation analyses
|
Measured at baseline (T1).
|
COVID-19 pandemic lockdown circumstances
Time Frame: Measured at baseline (T1), and one (T2) and two months (T3) post-randomisation.
|
Parents will provide information on the pandemic-related restrictions they are currently facing.
This will include details of the current lockdown policy in their local area, whether parents are working from home, and whether children are being home-schooled.
COVID-19 pandemic lockdown circumstances are measured at baseline (T1) for moderation analyses and at one month (T2) and two months (T3) post-randomisation for descriptive purposes.
|
Measured at baseline (T1), and one (T2) and two months (T3) post-randomisation.
|
SDQ ADHD Symptoms
Time Frame: Measured at baseline (T1), and one (T2) and two months (T3) post-randomisation.
|
This five item subscale measures restlessness, overactivity and inattention rated on 3-point Likert scales (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.
SDQ ADHD symptoms are measured at baseline (T1) for moderation analyses, and at one (T2) and two months (T3) post-randomisation for calculation of QALYs for the cost-effectiveness analysis.
|
Measured at baseline (T1), and one (T2) and two months (T3) post-randomisation.
|
SDQ Peer Problems
Time Frame: Measured at baseline (T1), and one (T2) and two months (T3) post-randomisation.
|
This five item subscale measures difficulties in peer relationships and bullying rated on 3-point Likert scales (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 peer problems subscale score.
SDQ Peer Problems are measured at baseline (T1), and at one month (T2) and two months (T3) post-randomisation for calculation of QALYs for the cost-effectiveness analysis.
|
Measured at baseline (T1), and one (T2) and two months (T3) post-randomisation.
|
SDQ Prosocial Behaviour
Time Frame: Measured at baseline (T1), and one (T2) and two months (T3) post-randomisation.
|
This five item subscale measures difficulties in peer relationships and bullying rated on 3-point Likert scales (not true, somewhat true, and certainly true), with positively phrased items.
Individual items' scores are summed to derive an overall prosocial subscale score with higher scores indicating more prosocial behaviour.
SDQ Prosocial Behaviour are measured at baseline (T1), and at one month (T2) and two months (T3) post-randomisation for calculation of QALYs for the cost-effectiveness analysis.
|
Measured at baseline (T1), and one (T2) and two months (T3) post-randomisation.
|
Estimate of resource use for the health economic analysis
Time Frame: Measured at one (T2) and two months post-randomisation (T3).
|
Information about use over the two-month period from randomisation of key health and social services known from published studies to be of relevance to the current population will be collected using a modified version of the Child and Adolescent Service Use Schedule (CA-SUS; Barrett et al., 2012) completed by the parent/carer in order to inform health economic analyses.
|
Measured at one (T2) and two months post-randomisation (T3).
|
Attitudes to Parent Positive
Time Frame: Measured at one (T2) and two months (T3) post-randomisation.
|
Parent mean ratings of Parent Positive using a questionnaire, consisting of three items measuring parents' ratings of the usefulness of each individual zone rated on a 7-point scale (1 = not useful at all to 7 = very useful), which will be summed up to derive an overall app usefulness score.
The questionnaire will also capture parents' descriptive and qualitative views of Parent Positive - both positive and negative.
This will only be measured among those in the Parent Positive arm.
|
Measured at one (T2) and two months (T3) post-randomisation.
|
App usage data
Time Frame: Measured at one (T2) and two months (T3) post-randomisation.
|
Usage data will be broken down by Parent Positive zones (Booster, Exchange, Hub).
This will allow descriptive analysis of usage patterns.
The analysis of the impact of usage levels on the effects of Parent Positive will be based on a derived measure of total time accessing the "Booster" zone during the intervening period.
Other app usage metrics will be collected (e.g., engagement in Exchange zone).
This will only be measured among those in the Parent Positive arm.
|
Measured at one (T2) and two months (T3) post-randomisation.
|
Adverse events
Time Frame: Measured at one (T2) and two months (T3) post-randomisation.
|
Self-reported standard medical and pre-specified psychological events deemed relevant to the intervention and population group (e.g., increase in detrimental child behaviour, increased family conflict, child protection concerns).
|
Measured at one (T2) and two months (T3) post-randomisation.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Edmund Sonuga-Barke, PhD, edmund.sonuga-barke@kcl.ac.uk
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SPARKLE; REC #:HR-20/21-21451
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
- Clinical Study Report (CSR)
Study Data/Documents
-
Statistical Analysis Plan
Information comments: The SAP can be accessed on this website.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Child Behavior Problem
-
Children's Hospital Los AngelesNational Institute on Minority Health and Health Disparities (NIMHD)Not yet recruitingChild Behavior | Child Behavior Problem | Child Behavior Disorders | Racism
-
Children's Hospital of PhiladelphiaPNC FoundationTerminatedChild Behavior | Child Development | Child Behavior ProblemUnited States
-
Children's Hospital Los AngelesNational Center for Advancing Translational Sciences (NCATS); AltaMed Health...SuspendedParenting | Child Behavior Problem | Child RearingUnited States
-
Sykehuset TelemarkEnrolling by invitationChild Behavior Problem | Psychiatric Problem | DDP | Child Neglect | MaltreatmentNorway
-
University of OxfordUniversity of Cape Town; Mahidol Oxford Tropical Medicine Research Unit; Bureau... and other collaboratorsCompletedParent-Child Relations | Parenting | Child Behavior Problem | Depression, Anxiety | Domestic Violence | Parent Child Abuse | Parent-child Problem | Child NeglectThailand
-
Karolinska InstitutetRegion StockholmActive, not recruitingParent-Child Relations | Parenting | Child Behavior Problem | Adult ADHDSweden
-
University of PittsburghThe Grable Foundation; The Shear Family Foundation; Heinz EndowmentsRecruitingParenting | Child Development | Child Behavior Problem | Parent Child Abuse | Child LanguageUnited States
-
Ateneo de Manila UniversityUniversity of Oxford; University of Cape Town; Philippines Department of Social... and other collaboratorsCompletedParent-Child Relations | Parenting | Child Behavior Problem | Child MaltreatmentPhilippines
-
Children's Hospital of PhiladelphiaAnnie E. Casey Foundation; The Pew Charitable TrustsCompletedParent-Child Relations | Child Behavior ProblemUnited States
-
University of MinnesotaEnrolling by invitationParent-Child Relations | Parents | Behavior Problem | Behavior, ChildUnited States
Clinical Trials on Parent Positive
-
Oregon Health and Science UniversityCompleted
-
Makerere UniversityCompleted
-
InquisitHealth, Inc.Eunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsUnknown
-
Rush University Medical CenterNational Institute of Nursing Research (NINR)Completed
-
University of ChicagoNational Institute on Minority Health and Health Disparities (NIMHD)RecruitingEmpowerment | Children With Medical Complexity | Invasive Mechanical Ventilation | Home NursingUnited States
-
University of FloridaNational Institute on Alcohol Abuse and Alcoholism (NIAAA)WithdrawnDrug Abuse | Alcohol AbuseUnited States
-
Oregon Social Learning CenterNational Institute of Mental Health (NIMH)CompletedChild Welfare | Foster Home CareUnited States
-
San Diego State UniversityNational Institute of Mental Health (NIMH); Oregon Social Learning CenterCompletedBehavior ProblemsUnited States
-
Johns Hopkins Bloomberg School of Public HealthCompleted
-
Centers for Disease Control and PreventionUniversity of GeorgiaCompletedHIV Infections | Sexually Transmitted Diseases | PregnancyUnited States