Supporting Parents & Kids Through Lockdown Experiences (SPARKLE).

Mental Health Issue Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04786080
• Other study ID #: SPARKLE; REC #:HR-20/21-21451
• Status: Completed
• Phase: N/A
• Start date: May 19, 2021
• Est. completion date: January 5, 2022

Study information

• Verified date: August 2022
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 646
• Est. completion date: January 5, 2022
• Est. primary completion date: October 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Child Behavior Problem
• Mental Health Issue
• Problem Behavior

Intervention

Behavioral:
• Parent Positive
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.

Locations

Country	Name	City	State
United Kingdom	King's College London	London

Sponsors (2)

Lead Sponsor	Collaborator
King's College London	University of Oxford

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Family characteristics and demographic measures	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).
Other	COVID-19 pandemic lockdown circumstances	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.
Other	SDQ ADHD Symptoms	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.
Other	SDQ Peer Problems	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.
Other	SDQ Prosocial Behaviour	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.
Other	Estimate of resource use for the health economic analysis	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).
Other	Attitudes to Parent Positive	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.
Other	App usage data	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.
Other	Adverse events	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.
Primary	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	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).
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.

External Links

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