Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000800729
Ethics application status
Approved
Date submitted
12/04/2022
Date registered
8/06/2022
Date last updated
8/06/2022
Date data sharing statement initially provided
8/06/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Protocol of a mixed-method feasibility, acceptability, and appropriateness trial of the Bright Tomorrows Parenting app in engaging parents of young children aged 0-5 years, in brain-building activities
Scientific title
The Bright Tomorrows Parenting App: Protocol of a mixed-method feasibility, acceptability, and appropriateness trial to engage parents of young children 0-5 years in brain-building activities
Secondary ID [1] 306866 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive development 326016 0
Developmental delay 326133 0
Executive functions 326134 0
Parent-child interactions 326135 0
Condition category
Condition code
Public Health 323323 323323 0 0
Health promotion/education
Mental Health 323454 323454 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Description of the app: The Bright Tomorrows Parenting app was created to fill a critical niche in the Australian early childhood landscape of evidence-based, multi-generational, positive parenting apps The app was co-designed with parents, child development experts, educators, and service providers as a translation-science platform that brings the science of ‘brain-building basics’ out of the laboratory directly to the fingertips of Australian parents and other professionals that are part of a family’s daily life. The app is housed within a larger set of tools and resources (website, factsheet, videos, https://www.brighttomorrows.org.au/) designed to inspire families to transform their daily interactions with their children into “brain building shared moments”.
The Bright Tomorrows Parenting app aims to strengthen parents and their children’s essential life skills (encompassing socioemotional wellbeing and executive function, EF processes), build parent knowledge of child development, attitude towards and skills to engage in positive parenting practices, and self-efficacy to improve their children’s learning, development, and care, whilst simultaneously motivating them to engage in self-care practices and access available support services
The key features of the app include:
• A video to introduce viewers to the app and explain its purpose and a series of pop-up videos that explain the various categories of essential life skills and their importance in the context of nurturing and responsive parent-child interactions for healthy brain development in young children
• Family tab: To sign into the app and create parent and associated children’s profiles. Users are guided through creating their profile, adding children, prioritising areas of parenting interest or concern, and monitoring progress:
• A unique tailoring system for activities, precisely personalised to the app user through details provided in their profile, including their child’s name, age, and priorities for learning
• An information library with over 1000 fun and interactive, ‘in-the-moment brain-building activities’ (referred to as Moments) and associated parenting tips (A Tip for You) to build essential life skills of the parent-child dyad and foster positive parenting practices. Moments are organised in the app’s wireframe by child age, type of essential life skill it is designed to develop, and place and time to use it. Essential life skill categories include: Attention and focus; Responding to emotions; Relationships and communication; Planning and routines; and Taking on challenges. Moments use action-oriented prompts while recommending fun and interactive activities that can be easily incorporated into a busy family’s daily routine (e.g., Bathtime Sing-a-long, Laundry load, Food finder, etc…). A typical Moment can be implemented within 1-2 minutes without additional preparation, resources, or toys.
• Each ‘Moment’ has an explanation of the science behind each activity and how it supports children’s brain development and essential life skills (i.e., the ‘Brainy Background’, powered by Vroom) and gives the user the opportunity to favourite it.
• Alongside each Moment is a tip for building the adult’s life skills housed in the A Tip for You section.
• A Growth (parent course) section to provide more comprehensive support to parents in developing essential life skills, both for themselves and their child. Each growth course contains moments, brain background and parenting tips and allows for tailored goal setting. To date, BTPA has 5-growth courses that focus on Finding calm, Sleep routine, Reading with my child, Getting active with my child, and Daily routine. This section of the app is currently under development.
• Support tab that directs parents to the web page or telephone line of various social and health supports in the community
• Notifications that act as an appropriately timed ‘nudge’ to encourage users to engage with the app
• Gamification to encourage parents’ engagement with the different components of the app, including badges awarded for completion of Moments.

Participation in the 8-week trial involved the following
Prior to the trial users:
• Complete a 15-minute online survey following online consent, capturing family demographics, relationship with their child, and parenting beliefs. Following survey completion, participants are welcomed to the study and provided with a link to the onboarding video.

During the trial users:
• Engage with the Bright Tomorrows Parenting app with their child over 8-weeks.
• Over the 8-week trial, participants are requested to:
• complete 2-new moments with their child at least 2-4 times a week; selecting moments ahead of their regular daily routines, e.g., bath time, playtime, or getting them dressed
• enrol in at least one growth course: around 2-4 weeks in duration, focusing on managing stress, morning routines and behaviour management etc.
• familiarise themselves with the app's support section, which connects them to various social and health supports in the community.
• respond to in-app strength-based notifications to support engagement in the trial
• Over the 8-week trial, researchers collect information on participants’ app usage - including, the number of times they used the app and for how long, what activities and courses they completed, and their satisfaction ratings with the completed activities.

After the trial, users:
• Complete a 15-minute online post-trial survey. In addition to pre-trial questions, users will rate the usability and satisfaction of the Bright Tomorrows app
• Participate in (an optional) 30-minute interview to discuss and understand the context surrounding their use of the Bright Tomorrows Parenting app with their child, their thoughts, and experiences in using the app, and ideas to improve the app. The interview will be conducted online at a time suitable to the participant and audio recorded to allow for detailed thematic analyses of transcripts to be conducted. Adherence will be monitored via in-app data analytics; 4-week mid-point SMS; and post-trial survey and interview
Intervention code [1] 323360 0
Behaviour
Intervention code [2] 323361 0
Prevention
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 331063 0
Primary outcome: Parent engagement with the Bright Tomorrows App

This is a composite outcome which will be measures using both quantitative and qualitative approaches

Quantitative measures of engagement: In-app log: A log of each parent's interactions with the app that is automatically uploaded to the dashboard will be analysed. These analytics will provide insight into how and when participants interact with the app.
Qualitative process evaluation of engagement: Mid-trial in week 4 (T1) 'in-the moment' information will be obtained on whether parents are enjoying using the app using an in-built SMS feature in REDCap called Twilio.

A validated measure of engagement called The TWEETS (TWente Engagement with Ehealth and Technologies Scale) will be used to measure behavioural, cognitive, and affective dimensions of engagement (Kelders et al., 2020), TWEETS has high internal consistency Cronbach alpha values of 0.86, 0.86, and 0.87. Test-retest reliability of the TWEETS is moderate with values ranging from (r = 0.58-0.74) (Kelders et al., 2020)
Timepoint [1] 331063 0
Data collection: Online surveys will be administered at baseline (T0) and post-trial (T2).
Baseline data collection will occur prior to onboarding and T2 data collection (survey + interview) will be scheduled within a week of completing the 8-week trial. Mid-trial, in Week-4 (T1) - participants will be contacted via the Twilio SMS system embedded within REDCap to measure in-the-moment engagement. Parents will be requested to complete the T2 surveys before the interview to minimise reference bias. The researchers will follow up with participants for a maximum of 3-occasions over 2-weeks (4-days apart) to encourage survey completion.
Primary outcome [2] 331195 0
Usability and satisfaction with the app: The 21-item mHealth app usability questionnaire, designed specifically to measure the usability and satisfaction of end-users with mobile apps will be used (Zhou et al., 2019). The measure has a high internal consistency alpha = 0.93. Strong correlations between the mHealth App Usability Questionnaire and other validated usability measures support its criterion validity.
Timepoint [2] 331195 0
Data collection: Online surveys will be administered at baseline (T0) and post-trial (T2). The post-trial interview will be at T2. Mid-trial, in Week-4 (T1) - participants will be contacted via the Twilio SMS system embedded within REDCap to measure in-the-moment engagement.
Secondary outcome [1] 408612 0
Parent Empowerment and Efficacy: The 20-item Parent Empowerment and Efficacy Measure (PEEM), of Australian parents’ sense of control or capacity to engage confidently with the challenges of being a parent will be used (Freiberg et al., 2014). The scale has established construct validity, internal consistency (alpha = 0.92), concurrent validity and test-retest reliability (r = 0.84) for use in planning services, monitoring participant progress, and evaluating program effectiveness (Freiberg et al., 2014).
Timepoint [1] 408612 0
Data collection: Online surveys will be administered at baseline (T0) and post-trial (T2). The post-trial interview will be at T2.
Secondary outcome [2] 409136 0
Parent wellbeing: General psychological wellbeing of parents will be measured using the World Health Organization Wellbeing Index (WHO-5) (WHO, 1998).
Timepoint [2] 409136 0
Data collection: Online surveys will be administered at baseline (T0) and post-trial (T2). The post-trial interview will be at T2.

Eligibility
Key inclusion criteria
Inclusion criteria: Community-dwelling primary caregivers of children aged 0-5 years, with diverse demographic characteristics, including gender, socio-economic disadvantage/advantage, Cultural and Linguistic Diversity (CALD) groupings, and family structure were eligible. The term "parent" is used broadly to refer to any adult, biologically related to the child or not, who fulfills a primary caregiver role (parents, grandparents and/or caregivers). To be eligible, the parent must have a child aged 0-5 years and be:
i. 18-years or older at the time of consent
ii. Live in metropolitan Perth and/or major cities or areas outside of major cities in Western Australia (WA) and regional WA as defined by the Australian Standard Geographical Classification System (Australian Bureau of Statistics, 2011)
iii. Own an Apple or Android device
iv. Have a current email address or be willing to obtain one
v. Willing to create a profile on the Bright Tomorrows Parenting app and commit to recommended procedures (recommended dosage and data collection requirements) and
vi. Able to comprehend English at a level sufficient to read the app activity instructions and complete study requirements.

Criteria (iv, v and vi) to be confirmed via self-report on the consent form. Also, given that the current trial purpose is to establish feasibility of app engagement over 8-weeks, to avoid excluding children living in separated or single-parent households, there will be no inclusion-based limitations on the time a parent anticipates being / living with their child over the course of the trial.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria: The following parents were excluded from participation:
i. Parents of children 0-5 years, aged less than 18-years at the time of consent
ii. Children aged 0-5 years, born very preterm (born at 28-32 weeks of gestation) or extremely preterm (born at <28 weeks of gestation) or with a medical diagnosis (e.g., intellectual disability, cerebral palsy, autism, attention deficit hyperactivity disorder or chronic illness like hearing loss or visual impairment)
iii. Parents who participated in previous user-testings of the Bright Tomorrows Parenting app or report using the app frequently with their child were not eligible in the current trial to minimise the impact of confounding variables on outcomes.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Quantitative analyses: Data will be managed and analysed using SPSS 25 (IBM Corporation, 2015). Descriptive statistics will profile the sample, and Shapiro-Wilks tests will assess for normality distribution of the outcomes. The feasibility outcomes will be summarised using descriptive statistics where appropriate. Depending on the sample size and normality distribution of outcomes, either parametric statistics (independent t-tests) for continuous data or Pearson's tests for categorical data will be used to compare demographic and outcome measure differences based on sample demographics at baseline. Changes in outcomes over time will be accessed using an unpaired t-test or Mann-Whitney U for group comparisons. A p-value of less than .05, indicating a statistically significant result, will be adopted for all statistical tests.

Qualitative analysis: Audio recordings will be transcribed verbatim for analysis. Thematic analysis will be managed through NVivo software and following the six-phase guide to reflexive thematic analysis entailing (Braun & Clarke, 2006, 2019): familiarity with the data set; generating initial codes; searching for themes; reviewing themes (and producing a thematic 'map'); defining and naming themes, and producing the analytical report presented here. Analysis will begin during the data collection phase to support decision-making regarding sampling and saturation (Liamputtong, 2013). Several steps will be taken to enhance both the rigour and transparency of data collection and analyses and to document the active engagement of the researchers with the data – in line with the reflexive thematic analysis approach (Braun & Clarke, 2019).


Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
7/02/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/12/2022
Actual
Sample size
Target
35
Accrual to date
15
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 311184 0
Charities/Societies/Foundations
Name [1] 311184 0
Minderoo Foundation
Country [1] 311184 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Telethon Kids Institute
Address
Telethon Kids Institute
Northern Entrance, Perth Children's Hospital, 15 Hospital Ave, Nedlands WA 6009
Country
Australia
Secondary sponsor category [1] 312544 0
University
Name [1] 312544 0
The University of Western Australia
Address [1] 312544 0
The University of Western Australia
35 Stirling Hwy, Crawley WA 6009
Country [1] 312544 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310716 0
Human Research Ethics Committee of the University of Western Australia
Ethics committee address [1] 310716 0
Ethics committee country [1] 310716 0
Australia
Date submitted for ethics approval [1] 310716 0
Approval date [1] 310716 0
20/10/2021
Ethics approval number [1] 310716 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 118618 0
Prof Donna Cross
Address 118618 0
Telethon Kids Institute and The University of Western Australia
Northern Entrance, Perth Children's Hospital, 15 Hospital Ave, Nedlands WA 6009
Country 118618 0
Australia
Phone 118618 0
+61419926070
Fax 118618 0
Email 118618 0
donna.cross@telethonkids.org.au
Contact person for public queries
Name 118619 0
Sharmila Vaz
Address 118619 0
Telethon Kids Institute and The University of Western Australia
Northern Entrance, Perth Children's Hospital, 15 Hospital Ave, Nedlands WA 6009
Country 118619 0
Australia
Phone 118619 0
+61424847070
Fax 118619 0
Email 118619 0
sharmila.vaz@uwa.edu.au
Contact person for scientific queries
Name 118620 0
Sharmila Vaz
Address 118620 0
Telethon Kids Institute and The University of Western Australia
Northern Entrance, Perth Children's Hospital, 15 Hospital Ave, Nedlands WA 6009
Country 118620 0
Australia
Phone 118620 0
+61 424847070
Fax 118620 0
Email 118620 0
sharmila.vaz@uwa.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
In line with the National Health and Medical Research Council's Open Access Policy, de-identified data underlying published results will be made available
When will data be available (start and end dates)?
Data collection: 24/1/2022 to 30/6/2022

Data availability: At the time of publication - as per open access guidelines, and available for 5 years after publication
Available to whom?
Anyone who wishes to access
Available for what types of analyses?
Only to achieve the aims in the approved proposal
How or where can data be obtained?
Access subject to approvals by Principal Investigator
Dr Sharmila Vaz
Email: sharmila.vaz@telethonkids.org.au


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.