Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001023549
Ethics application status
Approved
Date submitted
12/06/2024
Date registered
22/08/2024
Date last updated
22/08/2024
Date data sharing statement initially provided
22/08/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A non-randomised trial comparing personalised versus non-personalised versions of the Daily Growth parenting app for emotion regulation in parents/carers and their children aged 2-5 years
Scientific title
A non-randomised trial comparing personalised versus non-personalised versions of the Daily Growth parenting app for emotion regulation in parents/carers and their children aged 2-5 years
Secondary ID [1] 312323 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record
ACTRN12624000937516 is the parent study of the current non-randomised study, and participants in Group 5 of ACTRN12624000937516 will be used as a control for this current study.

Health condition
Health condition(s) or problem(s) studied:
Child mental health 334077 0
Child development 334078 0
Emotion regulation 334079 0
Condition category
Condition code
Mental Health 330752 330752 0 0
Depression
Mental Health 330753 330753 0 0
Anxiety
Mental Health 330754 330754 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This research project involves a non-randomised trial comparing two versions of the Daily Growth smartphone parenting app for parents and carers of children aged 2-5 years. The two versions are from two separate trials: data will be compared between a new/current trial (version 2, n=400) and a previous trial (version 1, Group 5, ACTRN12624000937516).

The only difference between the two versions is the method for allocating participants to program type. Daily Growth offers three types of parenting support (Emotion Coaching; Active Play; Wayapa Wuurrk). In the previous trial, the type of parenting resource was randomly allocated; in the current trial, the allocation will be determined by a personalisation algorithm developed using machine learning.

The Daily Growth app prompts parents twice a day (morning/evening), and if they request support, offers brief 3-minute video 'micro-intervention' resources that provide immediate parenting support that is tailored to a recent parenting situation (e.g., child won't sit for meals; siblings fighting). Daily Growth offers three different types of parenting support: (1) Emotion Coaching; (2) Active Play; and (3) Wayapa Wuurrk (Indigenous led).

The previous, randomised controlled trial (RCT) tests a non-personalised version of Daily Growth with 1,200 caregivers of children aged 2-5 years (Group 5, ACTRN12624000937516). In this non-personalised version, participants are sent a brief 1-minute survey twice per day (7am; 7pm) with a question asking whether they want support right now. If participants say they want support, they are randomised in the moment to receive 1 of the 3 types of parenting support in the form of a 3-minute video.

The current trial will recruit a further 400 caregivers to receive a personalised version as a comparison to the 1,200 caregivers who received the non-personalised version. The personalised version of Daily Growth will use a machine learning algorithm. Personalisation aims to enhance the benefits of interventions by ensuring they are most relevant and meaningful for each individual. The Daily Growth personalisation algorithm will be developed using data from the 1,200 parents from the previous trial (Group 5, ACTRN12624000937516), including parent demographics and baseline parenting skills; parent app behaviour (e.g., ratings and completion times); contextual factors (e.g., time of day, stage, and type of intervention); and "priors” informed by literature and pilot data. The data collected will enable the algorithm to learn patterns and make personalised recommendations.

For the personalised version, the timing and combination of micro-interventions received by each participant over 6 weeks will vary depending on the algorithm, however, some participants may receive a combination of all three programs, while others may receive a combination of just one or two. Once patterns within the data have been learned, predictions from the trained algorithm will be evaluated in a ‘hold-out’ dataset from the previous RCT (Group 5, ACTRN12624000937516). We will then implement the algorithm in the current trial (n=400).

METHOD: Procedures for the new trial (n=400)

The current trial will use the same procedure as the comparison trial (Group 5, ACTRN12624000937516), which includes offering the same Daily Growth app and the same micro-intervention videos. The procedure is outlined in detail below:

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.

After completing the baseline survey, participants will begin the 6-week intervention period. Over this 6-week period, participants will have the opportunity to ‘unlock’ an intervention resource twice per day. 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.

A single item in the 1-minute survey will be used to determine whether participants are offered a video resource: "Would you like a resource?" The response options are:
• Yes - for a parenting challenge right now
• Yes - for future parenting challenges
• No - not needed
• No - too busy
Participants will be offered a video resource if they select one of the "Yes" responses.

If participants request a resource on this item, they will be invited to select from a list of 30 common parenting situations. The personalisation algorithm will then allocate participants to receive 1 of the 3 types of support (Emotion Coaching; Active Play; Wayapa Wuurrk) in the form of a 3-minute video resource tailored to their selected parenting situation. Participants will be invited to complete a 1-minute post-intervention survey 15 minutes later (allowing time to watch the video resource), which will remain open until the next 1-minute pre-intervention survey. Participants can only unlock intervention content (i.e., 3-minute video resources) via the daily surveys. Once unlocked, video resources are available on demand in the app.

The micro-intervention resources have been developed for Daily Growth and consist of 3-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 (i.e., 90 videos in total). 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
• General: General meltdowns; general unhappiness/whinging; general resisting; feeling disconnected from my child.
The videos will consist of a mix of talking heads, stock footage, and animation, with audio transcriptions also available.

Each of the three parenting programs offered to participants employ a unique approach to delivering parenting support, all focused on improving parent and child emotion regulation:

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; and 6 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] 328797 0
Prevention
Intervention code [2] 328798 0
Treatment: Other
Intervention code [3] 328799 0
Behaviour
Comparator / control treatment
Version 2 participants (i.e., participants receiving the personalised version of Daily Growth) will be compared to version 1, Group 5 participants in the previous RCT (i.e., participants receiving a randomised version; see ACTRN12624000937516).
Control group
Active

Outcomes
Primary outcome [1] 338513 0
Child emotion regulation
Timepoint [1] 338513 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] 338514 0
Parent emotion regulation
Timepoint [2] 338514 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] 436226 0
Child depression
Timepoint [1] 436226 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] 436227 0
Child negative affect
Timepoint [2] 436227 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] 436228 0
Child behaviour problems
Timepoint [3] 436228 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] 436229 0
Parent psychological distress
Timepoint [4] 436229 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] 436230 0
Parent stress
Timepoint [5] 436230 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] 436231 0
Emotion-focussed parenting practices
Timepoint [6] 436231 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] 436232 0
Inter-parental conflict
Timepoint [7] 436232 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] 436233 0
Home learning environment
Timepoint [8] 436233 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] 436234 0
Social support
Timepoint [9] 436234 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] 436235 0
Parent reflective functioning
Timepoint [10] 436235 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] 436236 0
Parent beliefs about child emotions
Timepoint [11] 436236 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] 436237 0
Mindful parenting
Timepoint [12] 436237 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
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
Other
Other design features
The control group will include participants who participate in a separate trial, where they will be randomised to one of three different types of parenting programs (version 1, Group 5, ACTRN12624000937516; estimated n=1,200). In this non-personalised version, participants are sent a brief 1-minute survey twice per day (7am; 7pm) with a question asking whether they want support right now. If participants say they want support, they are randomised in the moment to receive 1 of the 3 types of parenting support in the form of a 3-minute video.
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 (version 2; n=400) to a control condition (version 1, Group 5, ACTRN12624000937516; estimated n=1,200). 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
1/01/2027
Actual
Date of last participant enrolment
Anticipated
30/06/2027
Actual
Date of last data collection
Anticipated
31/12/2027
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 316718 0
Government body
Name [1] 316718 0
NHMRC Ideas Grant (GNT2019442)
Country [1] 316718 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Country
Australia
Secondary sponsor category [1] 318925 0
None
Name [1] 318925 0
Address [1] 318925 0
Country [1] 318925 0
Other collaborator category [1] 283082 0
University
Name [1] 283082 0
University of Melbourne
Address [1] 283082 0
Country [1] 283082 0
Australia
Other collaborator category [2] 283083 0
Charities/Societies/Foundations
Name [2] 283083 0
Meli
Address [2] 283083 0
Country [2] 283083 0
Australia
Other collaborator category [3] 283084 0
Other
Name [3] 283084 0
Wayapa Wuurrk
Address [3] 283084 0
Country [3] 283084 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315494 0
Deakin University Human Research Ethics Committee (DUHREC)
Ethics committee address [1] 315494 0
Ethics committee country [1] 315494 0
Australia
Date submitted for ethics approval [1] 315494 0
12/02/2024
Approval date [1] 315494 0
09/04/2024
Ethics approval number [1] 315494 0
2024-050

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

Contacts
Principal investigator
Name 134874 0
A/Prof Elizabeth Westrupp
Address 134874 0
Deakin University, 221 Burwood Highway, Burwood, VIC 3125
Country 134874 0
Australia
Phone 134874 0
+61 3 9246 8974
Fax 134874 0
Email 134874 0
[email protected]
Contact person for public queries
Name 134875 0
Elizabeth Westrupp
Address 134875 0
Deakin University, 221 Burwood Highway, Burwood, VIC 3125
Country 134875 0
Australia
Phone 134875 0
+61 3 9246 8974
Fax 134875 0
Email 134875 0
[email protected]
Contact person for scientific queries
Name 134876 0
Elizabeth Westrupp
Address 134876 0
Deakin University, 221 Burwood Highway, Burwood, VIC 3125
Country 134876 0
Australia
Phone 134876 0
+61 3 9246 8974
Fax 134876 0
Email 134876 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
23879Study protocol https://osf.io/rcq2x  A copy of the study protocol will be made availabl... [More Details]
23880Analytic code https://osf.io/rcq2x  A copy of the analytic code will be made available... [More Details]
23881Statistical analysis plan https://osf.io/rcq2x  A copy of the statistical analysis plan will be ma... [More Details]
23882Data 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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