Child Behavior ProblemSPARKLENCT04786080
Supporting Parents & Kids Through Lockdown Experiences (SPARKLE).
A study testing Parent Positive in people with Child Behavior Problem and Mental Health Issue, run by King's College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Child Behavior Problem, Mental Health Issue
- What is being tested?
- Parent Positive
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 646 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 May 2021to 5 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- There will be no exclusion criteria. Participants will not be selected on the basis of pre-existing child conduct problems.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read more
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
- Being tested
- Parent Positive
- Keywords
- Child Behaviour Problems, Parenting, Smartphone Application, COVID-19 Pandemic
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent PositiveBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured at one month post-randomisation (T2).
Secondary outcomes (5)
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: 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: 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: 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: 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: Measured at one (T2) and two months (T3) post-randomisation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start19 May 2021
- Primary completion10 Oct 2021
- Study completion5 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Child Behavior ProblemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 646 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oxford
- Responsible party
- Sponsor
- Investigators
- Edmund Sonuga-Barke, PhD, Principal investigator, edmund.sonuga-barke@kcl.ac.uk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04786080
- Sponsor's protocol ID
- SPARKLE; REC #:HR-20/21-21451
- Acronym
- SPARKLE
- Status last verified
- Aug 2022
- First submitted
- 24 Feb 2021
- Last updated
- 4 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: On completion of the study a clean, pseudonymised data set will be made available for open access via the UK Data Service or another suitable repository. Questionnaire and app data will be shared along with a procedures document, curation document and description of variables. Links to the data record will be provided in all papers published using the data.
Publications
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.
PubMed 39378100Palmer 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.
PubMed 37498669Kostyrka-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.
PubMed 33838678
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04786080
- Acronym / sponsor ID
- SPARKLE / SPARKLE; REC #:HR-20/21-21451
- Conditions
- Child Behavior Problem, Mental Health Issue
- Keywords
- Child Behaviour Problems, Parenting, Smartphone Application, COVID-19 Pandemic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 646 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- University of Oxford
- Study start
- 19 May 2021 (actual)
- Primary completion
- 10 Oct 2021 (actual)
- Study completion
- 5 Jan 2022 (actual)
- First posted
- 8 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Parent Positive | Experimental | Behavioral: Parent PositiveThis 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (1 listed)
- There will be no exclusion criteria. Participants will not be selected on the basis of pre-existing child conduct problems.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parent PositiveParent 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. | Behavioural | Parent Positive |
Primary outcome
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.
5 secondary outcomes
SDQ Conduct Problems
Time frame: Measured at two months post-randomisation (T3).
SDQ Emotional Problems
Time frame: 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.
Family conflict
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2022.
- Derived from this study: PubMed 39378100Pokorna 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.
- Derived from this study: PubMed 37498669Palmer 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.
- Derived from this study: PubMed 33838678Kostyrka-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.
- KCL SPARKLE Study press releaseLink provided by the sponsor.
- University of Oxford Co-SPACE websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. On completion of the study a clean, pseudonymised data set will be made available for open access via the UK Data Service or another suitable repository. Questionnaire and app data will be shared along with a procedures document, curation document and description of variables. Links to the data record will be provided in all papers published using the data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edmund Sonuga-Barke, PhD principal investigator
edmund.sonuga-barke@kcl.ac.uk
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent Positive in people with Child Behavior Problem and Mental Health Issue, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Strengths and Difficulties Questionnaire (SDQ; Goodman, 1997) Conduct Problems (time frame: Measured at one month post-randomisation (T2).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04786080, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2022.