Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000937516
Ethics application status
Approved
Date submitted
23/02/2024
Date registered
1/08/2024
Date last updated
1/08/2024
Date data sharing statement initially provided
1/08/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial investigating the effect of the Daily Growth parenting app on emotion regulation in parents/carers and their children aged 2-5 years
Scientific title
A randomised controlled trial investigating the effect of the Daily Growth parenting app on emotion regulation in parents/carers and their children aged 2-5 years
Secondary ID [1] 311585 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Child mental health 332967 0
Child development 332968 0
Emotion regulation 332969 0
Condition category
Condition code
Mental Health 329679 329679 0 0
Depression
Mental Health 329680 329680 0 0
Anxiety
Mental Health 329681 329681 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The research project will trial Daily Growth, a smartphone parenting app for parents and carers of children aged 2-5 years. Daily Growth will (1) offer participants brief 3-minute ‘micro’ video intervention resources that provide in-the-moment parenting support; (2) tailor each video resource to specific parenting situations; and (3) offer participants three types of parenting support: Emotion Coaching; Active Play; and Wayapa Wuurrk (Indigenous-led). The study aims to investigate whether providing parents with three different types of parenting programs improves outcomes, engagement, and retention compared to no intervention or just one type of parenting program.

The randomised controlled trial will compare five groups. Participants will be randomised to 1 of 5 groups (Groups 1-5), with participants in Groups 1-4 being compared to those in Group 5.

The five trial groups are:
1. Group 1 (n=150 participants): Control condition receiving no active intervention, but a link to the Raising Children Network website, a free Australian government parenting website overseen by the Department of Social Services.
2. Group 2 (n=100 participants): Control condition receiving one type of parenting intervention (Emotion Coaching).
3. Group 3 (n=100 participants): Control condition receiving one type of parenting intervention (Active Play).
4. Group 4 (n=100 participants): Control condition receiving one type of parenting intervention (Wayapa Wuurrk).
5. Group 5 (n=1,200 participants): Intervention condition randomised in the moment to receive one of three types of tailored micro-intervention. Over 6 weeks, participants will receive a random combination of all three types of programs.

After downloading the Daily Growth app, participants will be provided with a Plain Language Statement and asked to consent to participation. Following this, participants will be required to register with Daily Growth and will then be given access to Daily Growth, which begins with an introductory video tailored to the participant’s group. Participants will then complete a 20-minute baseline survey.

After completing the baseline survey, participants will begin the 6-week intervention period, during which they will be prompted twice daily (7:00am; 7:00pm) to complete a 1-minute pre-intervention survey on their smartphone and asked whether they want support in that moment. Participants will receive a further reminder notification 2 hours later (9:00am/pm) if the 1-minute survey has not been completed and will have 4 hours to complete the survey before it expires. If participants request support in the 1-minute survey, they will be invited to select from a list of 30 common parenting situations and provided with a resource. Group 2-5 participants will be provided with a 3-minute video resource tailored to the selected situation. Group 1 participants will be provided with a link to the Raising Children Network website. Regardless of condition, all participants will be invited to complete a 1-minute post-intervention survey 15 minutes later, which will remain open until the next 1-minute pre-intervention survey.

The micro-interventions have been developed for Daily Growth and consist of 90 three-minute videos that aim to provide parents with advice about difficult parenting situations. Each video will offer parenting support grounded in one of three parenting programs (Emotion Coaching; Active Play; Wayapa Wuurrk), with each program offering 30 unique videos. The parenting situations, and the themes they sit under, are listed below:
• Eating/Food: Eating challenges; sitting for meals; wanting treats
• Morning/Evening routine: Going to bed; not staying in bed; bathing/showering; brushing teeth
• Siblings/Peers: Conflict between children; sharing difficulties; refusing to play; fighting in the car
• Car/Road/Safety: Crossing the road; child out of sight; fighting in the car
• Clingy/Resistant: Clingy with you; clingy with others; stopping an activity; sitting for meals
• Screen time: Demanding screens; turning off screens
• Getting dressed: Resisting dressing; putting shoes on; dressing for the weather; refusing help to dress
In addition, all 3 programs will offer a video about general meltdowns, general unhappiness/whinging, general resisting, and feeling disconnected from my child. The videos will consist of a mix of talking heads, stock footage, and animation, with audio transcriptions also available.

The three parenting programs offered to participants employ a unique approach to delivering parenting support:

Emotion Coaching
The Emotion Coaching program in Daily Growth focuses on teaching children the soft skills needed in the modern world to succeed. Emotion Coaching teaches parents how to notice their own emotions; to understand their child’s needs; to notice, accept, and label all of their child’s emotions; and to empathise and connect with their child. It also teaches parents how to reflect on behaviour they regret, take responsibility, make amends, and model these skills to their child.

Active Play
The Active Play program offers a set of games to help children connect with their body. Active Play draws on scientific evidence showing how physical activity and play can be used to manage stress and difficult emotions, as well as promoting brain development. The games are designed to help children move in ways that support their emotional and physical development, while also having fun, and connecting with parents.

Wayapa Wuurrk
Wayapa Wuurrk helps parents connect to the wisdom of the Earth so that they can create rhythms and rituals for gratitude and balance to pass on to their children. The Wayapa Wuurrk Ways remind parents that we are nature, so when parents connect with and look after the Earth, they can create a deeper connection to themselves, their child, and to their community, creating resilience, harmony, and wellbeing for all.

Finally, at the completion of the 6-week intervention period, participants will be invited to complete a 20-minute post survey. Six months following the completion of the intervention period, participants will be invited to complete the final 20-minute follow-up survey.

Participant engagement will be monitored periodically using data collected from the Daily Growth app, with reminders sent via email and smartphone push notifications to participants who do not engage with the app for an extended period of time.
Intervention code [1] 328038 0
Prevention
Intervention code [2] 328039 0
Treatment: Other
Intervention code [3] 328040 0
Behaviour
Comparator / control treatment
Group 1 participants will not receive any of the Daily Growth programs. Instead, when these participants request a parenting resource, they will be directed to an Australian government parenting website, the Raising Children Network, a free website overseen by the Department of Social Services that provides age-appropriate and evidence-based parenting advice for the Australian public.
Control group
Active

Outcomes
Primary outcome [1] 337464 0
Child emotion regulation
Timepoint [1] 337464 0
Child emotion regulation will be assessed at baseline, at the conclusion of the six-week intervention period (post; primary endpoint), and six months after the conclusion of the intervention period (follow-up).
Primary outcome [2] 337470 0
Parent emotion regulation
Timepoint [2] 337470 0
Parent emotion regulation will be assessed at baseline, at the conclusion of the six-week intervention period (post; primary endpoint), and six months after the conclusion of the intervention period (follow-up).
Secondary outcome [1] 431960 0
Child depression
Timepoint [1] 431960 0
Assessed at baseline, at the conclusion of the six-week intervention period (post), and six months after the conclusion of the intervention period (follow-up).
Secondary outcome [2] 431961 0
Child negative affect
Timepoint [2] 431961 0
Assessed at baseline, at the conclusion of the six-week intervention period (post), and six months after the conclusion of the intervention period (follow-up).
Secondary outcome [3] 431962 0
Child behaviour problems
Timepoint [3] 431962 0
Assessed at baseline, at the conclusion of the six-week intervention period (post), and six months after the conclusion of the intervention period (follow-up).
Secondary outcome [4] 431963 0
Parent psychological distress
Timepoint [4] 431963 0
Assessed at baseline, at the conclusion of the six-week intervention period (post), and six months after the conclusion of the intervention period (follow-up).
Secondary outcome [5] 431964 0
Parent stress
Timepoint [5] 431964 0
Assessed at baseline, at the conclusion of the six-week intervention period (post), and six months after the conclusion of the intervention period (follow-up).
Secondary outcome [6] 431965 0
Emotion-focussed parenting practices
Timepoint [6] 431965 0
Assessed at baseline, at the conclusion of the six-week intervention period (post), and six months after the conclusion of the intervention period (follow-up).
Secondary outcome [7] 431966 0
Inter-parental conflict
Timepoint [7] 431966 0
Assessed at baseline, at the conclusion of the six-week intervention period (post), and six months after the conclusion of the intervention period (follow-up).
Secondary outcome [8] 431967 0
Home learning environment
Timepoint [8] 431967 0
Assessed at baseline, at the conclusion of the six-week intervention period (post), and six months after the conclusion of the intervention period (follow-up).
Secondary outcome [9] 431968 0
Social support
Timepoint [9] 431968 0
Assessed at baseline, at the conclusion of the six-week intervention period (post), and six months after the conclusion of the intervention period (follow-up).
Secondary outcome [10] 431969 0
Parent reflective functioning
Timepoint [10] 431969 0
Assessed at baseline, at the conclusion of the six-week intervention period (post), and six months after the conclusion of the intervention period (follow-up).
Secondary outcome [11] 431970 0
Parent beliefs about child emotions
Timepoint [11] 431970 0
Assessed at baseline, at the conclusion of the six-week intervention period (post), and six months after the conclusion of the intervention period (follow-up).
Secondary outcome [12] 431971 0
Mindful parenting
Timepoint [12] 431971 0
Assessed at baseline, at the conclusion of the six-week intervention period (post), and six months after the conclusion of the intervention period (follow-up).

Eligibility
Key inclusion criteria
Participants must be 18 years of age or over, be a parent or carer (including biological, step, foster, adoptive, or grandparent) of a child aged 2-5 years, and reside in Victoria.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
All information related to the study, such as recruitment materials, app content, and surveys, will be written in English. While non-English speakers will not be explicitly excluded, it is expected that only English speakers will participate, based on their ability to comprehend the advertisements and provide informed consent.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation will be utilised to allocate participants to groups for Groups 1-5 and will occur in two consecutive phases to accommodate two different recruitment approaches: Phase 1 and Phase 2. In both phases, participants will only be allocated to a group on completion of the baseline survey.

Phase 1 will recruit 25% of the sample, with participants randomly allocated to a group within one of 30 blocks. Each block will contain 17 allocations proportional to overall group sizes (3x Group 1; 1x Group 2; 1x Group 3; 1x Group 4; 11x Group 5.) Blocks will be filled one at a time, meaning participants will be randomly allocated to a group within a block until all allocations in the block are full. Once all 17 allocations in a block are filled, participants will be randomly allocated to a group in the next block until the entire Phase 1 sample is recruited.

Phase 2 will recruit the remaining 75% of the sample and will follow the same allocation approach as Phase 1, but will have 90 blocks with 15 participants each. The allocation for each block in Phase 2 will be: 1x Group 1; 1x Group 2; 1x Group 3; 1x Group 4; 11x Group 5.

In addition to the above, participants in Group 5 who request a video resource will be randomised to receive one of the 3 parenting programs each time. This means that a Group 5 participant may receive any of the Emotion Coaching, Active Play, or Wayapa Wuurrk for the requested scenario, including seeing the same video from the same program in succession.

To be able to compare the effectiveness of recruitment approaches between phases, 50 additional Group 1 participants will be recruited in Phase 1 to achieve an equal sample size between Group 1 participants in Phase 1 and Phase 2.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size for matrix factorisation or other machine learning algorithms cannot be calculated a priori because model performance is entirely based on the strength of the signals underlying a dataset. However, we demonstrate statistical power for a key comparison between in-the-moment symptom improvement in the personalisation condition (Group 6; n=400) to a control condition (e.g., Group 1; no intervention; estimated n=100). Effective Sample Size (ESS) is used to adjust power estimates to account for clustering (ESS=nm/[1+[m-1]rho]; n=participants, m=datapoints per cluster, rho=within correlation). This analysis will have an ESS = 560 (conservative rho=.7), based on 6 weeks of data collection; twice-daily surveys; an estimated 25% triggering rate for a micro-intervention (i.e., we estimate that participants will report parent/child emotion dysregulation in 25% of completed surveys); and estimating 20% attrition. Using Monte Carlo simulation (10,000 draws) in Mplus 8, this ESS provides >80% power to detect even a very small difference between the two conditions (d=.12; a=.05). This example analysis uses conditions with the smallest sample sizes, thus all of our primary analyses are powered to detect very small true effects of interest.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2024
Actual
Date of last participant enrolment
Anticipated
31/12/2025
Actual
Date of last data collection
Anticipated
30/06/2026
Actual
Sample size
Target
1650
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 315892 0
Government body
Name [1] 315892 0
NHMRC Ideas Grant (GNT2019442)
Country [1] 315892 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Country
Australia
Secondary sponsor category [1] 318037 0
None
Name [1] 318037 0
Address [1] 318037 0
Country [1] 318037 0
Other collaborator category [1] 282961 0
University
Name [1] 282961 0
University of Melbourne
Address [1] 282961 0
Country [1] 282961 0
Australia
Other collaborator category [2] 282962 0
Charities/Societies/Foundations
Name [2] 282962 0
Meli
Address [2] 282962 0
Country [2] 282962 0
Australia
Other collaborator category [3] 282963 0
Other
Name [3] 282963 0
Wayapa Wuurrk
Address [3] 282963 0
Country [3] 282963 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314733 0
Deakin University Human Research Ethics Committee (DUHREC)
Ethics committee address [1] 314733 0
Ethics committee country [1] 314733 0
Australia
Date submitted for ethics approval [1] 314733 0
12/02/2024
Approval date [1] 314733 0
09/04/2024
Ethics approval number [1] 314733 0
2024-050

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

Contacts
Principal investigator
Name 132562 0
A/Prof Elizabeth Westrupp
Address 132562 0
Deakin University, 221 Burwood Highway, Burwood, VIC 3125
Country 132562 0
Australia
Phone 132562 0
+61 3 9246 8974
Fax 132562 0
Email 132562 0
[email protected]
Contact person for public queries
Name 132563 0
Elizabeth Westrupp
Address 132563 0
Deakin University, 221 Burwood Highway, Burwood, VIC 3125
Country 132563 0
Australia
Phone 132563 0
+61 3 9246 8974
Fax 132563 0
Email 132563 0
[email protected]
Contact person for scientific queries
Name 132564 0
Elizabeth Westrupp
Address 132564 0
Deakin University, 221 Burwood Highway, Burwood, VIC 3125
Country 132564 0
Australia
Phone 132564 0
+61 3 9246 8974
Fax 132564 0
Email 132564 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All participant data will be shared on public data repositories (such as the Open Science Framework) after they have been made non-identifiable.
When will data be available (start and end dates)?
Data will be available immediately after initial results have been published, with no end date.
Available to whom?
Non-identifiable data will be publicly available on public data repositories.
Available for what types of analyses?
Data will be available for any type of analyses.
How or where can data be obtained?
Data will be available on the Open Science Framework (https://osf.io) and the Australian Data Archive (https://ada.edu.au).


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21701Study protocol https://osf.io/rcq2x  A copy of the study protocol will be made availabl... [More Details]
21702Analytic code https://osf.io/rcq2x  A copy of the analytic code will be made available... [More Details]
21703Statistical analysis plan https://osf.io/rcq2x  A copy of the statistical analysis plan will be ma... [More Details]
21704Data dictionary https://osf.io/rcq2x  A copy of the data dictionary will be made availab... [More Details]



Results publications and other study-related documents

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