Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001410549
Ethics application status
Approved
Date submitted
25/10/2024
Date registered
29/11/2024
Date last updated
29/11/2024
Date data sharing statement initially provided
29/11/2024
Date results provided
29/11/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
A pilot randomised controlled trial investigating feasibility and acceptability of the prototype Daily Growth parenting program in parents/carers and their children aged 2-4 years
Scientific title
A pilot randomised controlled trial investigating feasibility and acceptability of the prototype Daily Growth parenting program in parents/carers and their children aged 2-4 years
Secondary ID [1] 312769 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record
The current trial is a pilot study conducted in 2023, testing a prototype version of the Daily Growth parenting app. Findings from this pilot study informed the larger randomised controlled trial, currently underway with data collection planned 2025-26 (ACTRN12624000937516). A third non-randomised trial (ACTRN12624001023549) is planned at the completion of both trials (2026-7), to test a personalised algorithm in comparison to findings from the randomised controlled trial (ACTRN12624000937516).

Health condition
Health condition(s) or problem(s) studied:
Emotion regulation 334809 0
Child mental health 334807 0
Child development 334808 0
Condition category
Condition code
Mental Health 331367 331367 0 0
Depression
Mental Health 331370 331370 0 0
Studies of normal psychology, cognitive function and behaviour
Mental Health 331369 331369 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This pilot randomised controlled trial aimed to assess the feasibility and acceptability of a prototype for a novel parenting program aimed at improving community reach and engagement. The Daily Growth parenting program uses an ecological momentary intervention design, sending twice-daily 1-minute surveys, and offering 3-minute videos tailored to a specific parenting situation. The current study tested a small prototype version of Daily Growth. The final Daily Growth program will be offered as an app and offer parents/carers a combination of three different parenting programs over six weeks. However, this pilot study tested a prototype version via a web platform (not an app), offering just two of the three programs (Emotion Coaching; Active Play), each program offering 5 tailored 3-minute video resources (out of a planned 30 resources per program) over two weeks.

To participate, participants first registered to a web platform developed at Deakin University called 'Platform O', and then completed a baseline survey through Qualtrics (approx. 25 minutes). On completion of the baseline survey, participants were randomised to either a control or intervention group, via a random assignment (1:1 ratio) generator. Participants in both control and intervention condition were sent a 1-minute ‘pre’ ecological momentary intervention (pre-EMI) survey, at 7.30am and 7.30pm, every day for 2 weeks. The 1-minute EMI survey asked questions about parent and child emotion regulation and child emotions. Parents were also asked to select 1 of 5 challenging situations they had recently experienced (e.g., issues with eating). Participants in both control and intervention condition were offered an intervention if they reported that they or their child were experiencing negative affect or having difficulty regulating their emotions.

Parents in the intervention condition were randomised in-the-moment to receive 1 of 2 types of a micro-intervention (i.e., a 3-minute video), from either the Active Play program or the Emotion Coaching program. Regardless of the program they received, the 3-minute video was tailored to provide supportive advice specific to the parenting situation they had selected. Participants in the control condition were also sent a tailored link to the Raising Children Network government parenting website, directing them to a webpage that provided information specific to the parenting situation they had selected.

A post-EMI survey was sent to participants at 7:45am and 7:45pm. This survey repeated the same items asking about parents' emotion regulation and their children's emotions (but did not repeat the question about challenging parenting situations). Finally, at the end of 2 weeks, parents were asked to complete a 25-minute post-intervention survey.

Due to a technical problem, approximately half of the sample enrolled in this pilot experienced an issue. Programming for the post-EMI survey required that participants must have completed their pre-EMI survey within 15 minutes of receiving the invitation email. This unfortunately meant that most participants did not reliably receive the post-EMI survey throughout the two-week period. This technical problem was identified and corrected half-way through the trial to remove the time-requirement – participants were not required to complete the pre-survey within 15 minutes (the survey was available all day), and the post EMI survey prompt was sent to all Group 2 participants, regardless of their cut-point score on the pre-survey. Given that our data analyses focussed on describing survey completion rates, we separated participants affected by this technical problem (Group 1) with those enrolled later in the study and not affected (Group 2). We note that there were no other differences between these groups, and that there were roughly equal representation of control and intervention conditions across Groups 1 and 2.

Daily Growth Program Resources

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.
Intervention code [1] 329337 0
Behaviour
Intervention code [2] 329335 0
Prevention
Intervention code [3] 329336 0
Treatment: Other
Comparator / control treatment
Control participants did not receive a microintervention video. Instead, they were 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. The specific webpage parents were directed to was tailored to the challenging parenting situation they were experiencing.
Control group
Active

Outcomes
Primary outcome [1] 339168 0
Child emotion regulation.
Timepoint [1] 339168 0
Assessed at baseline, and at the conclusion of the two-week intervention period.
Primary outcome [2] 339169 0
Parent emotion regulation.
Timepoint [2] 339169 0
Assessed at baseline, and at the conclusion of the two-week intervention period.
Secondary outcome [1] 438877 0
Children's anxiety.
Timepoint [1] 438877 0
Assessed at baseline, and at the conclusion of the two-week intervention period.
Secondary outcome [2] 440868 0
Parents' beliefs about children’s emotions.
Timepoint [2] 440868 0
Assessed at baseline, and at the conclusion of the two-week intervention period.
Secondary outcome [3] 438879 0
Children's negative affect.
Timepoint [3] 438879 0
Assessed at baseline, and at the conclusion of the two-week intervention period.
Secondary outcome [4] 441820 0
Acceptability.
Timepoint [4] 441820 0
Assessed at the conclusion of the two-week intervention period.
Secondary outcome [5] 438875 0
Children's behavioural problems.
Timepoint [5] 438875 0
Assessed at baseline, and at the conclusion of the two-week intervention period.
Secondary outcome [6] 440869 0
Family emotional climate.
Timepoint [6] 440869 0
Assessed at baseline, and at the conclusion of the two-week intervention period.
Secondary outcome [7] 441817 0
Engagement.
Timepoint [7] 441817 0
Cumulative data assessed at the conclusion of the recruitment period.
Secondary outcome [8] 438891 0
Parent positive and negative affect.
Timepoint [8] 438891 0
Assessed at baseline, and at the conclusion of the two-week intervention period.
Secondary outcome [9] 438878 0
Children's depression.
Timepoint [9] 438878 0
Assessed at baseline, and at the conclusion of the two-week intervention period.
Secondary outcome [10] 438893 0
Parent stress.
Timepoint [10] 438893 0
Assessed at baseline, and at the conclusion of the two-week intervention period.
Secondary outcome [11] 438894 0
Emotion-related parenting.
Timepoint [11] 438894 0
Assessed at baseline, and at the conclusion of the two-week intervention period.
Secondary outcome [12] 438896 0
Parental reflective functioning.
Timepoint [12] 438896 0
Assessed at baseline, and at the conclusion of the two-week intervention period.
Secondary outcome [13] 441815 0
Recruitment rates.
Timepoint [13] 441815 0
Cumulative data assessed at the conclusion of the recruitment period.
Secondary outcome [14] 438892 0
Parent psychological distress.
Timepoint [14] 438892 0
Assessed at baseline, and at the conclusion of the two-week intervention period.
Secondary outcome [15] 441816 0
Retention.
Timepoint [15] 441816 0
Assessed with data collected at baseline, and at the conclusion of the two-week intervention period.

Eligibility
Key inclusion criteria
Participants were eligible to participate if they were a resident of Australia, 18 years or older, and a current parent (i.e., biological, step, etc.) of a child aged 2 to 4 years.

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, was written in English. While non-English speakers were not explicitly excluded, only English speakers could 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)
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Participant's responses to the baseline, post-surveys, and daily EMI surveys were analysed with descriptive statistics in order to summarise recruitment, retention and engagement rates.

Pearson pairwise associations were tested between demographic characteristics and level of engagement with pre-and-post-EMI surveys and the post-survey.

To assess program acceptability, user satisfaction items that were included in the post-survey were analysed using descriptive statistics.

To assess feasibility in the context of condition changes and differences, Bonferroni-adjusted linear regression analyses were conducted for parent and child outcomes. In each model, parents' condition - intervention versus control, was included as the independent variables (i.e., a categorical variable); and a post-outcome variable was included as a dependent variable, such as parents' emotion regulation

Pre- and post-EMI daily survey data were analysed using linear mixed-effects regression models. These models included fixed effects (to control for group and timepoint) and random effects (to control for individual variations over time). Robust standard errors controlled for the clustering of observations within participants.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
17/03/2023
Date of last participant enrolment
Anticipated
Actual
4/04/2023
Date of last data collection
Anticipated
Actual
18/04/2023
Sample size
Target
150
Accrual to date
Final
184
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 317201 0
University
Name [1] 317201 0
Deakin University
Country [1] 317201 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Country
Australia
Secondary sponsor category [1] 319527 0
None
Name [1] 319527 0
Address [1] 319527 0
Country [1] 319527 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315940 0
Deakin University Human Research Ethics Committee (DUHREC)
Ethics committee address [1] 315940 0
Ethics committee country [1] 315940 0
Australia
Date submitted for ethics approval [1] 315940 0
01/11/2022
Approval date [1] 315940 0
09/01/2023
Ethics approval number [1] 315940 0
HEAG-H 188_2022

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

Contacts
Principal investigator
Name 136286 0
A/Prof Elizabeth Westrupp
Address 136286 0
Deakin University, 221 Burwood Highway, Burwood, VIC 3125
Country 136286 0
Australia
Phone 136286 0
+61 3 9246 8974
Fax 136286 0
Email 136286 0
[email protected]
Contact person for public queries
Name 136287 0
Elizabeth Westrupp
Address 136287 0
Deakin University, 221 Burwood Highway, Burwood, VIC 3125
Country 136287 0
Australia
Phone 136287 0
+61 3 9246 8974
Fax 136287 0
Email 136287 0
[email protected]
Contact person for scientific queries
Name 136288 0
Elizabeth Westrupp
Address 136288 0
Deakin University, 221 Burwood Highway, Burwood, VIC 3125
Country 136288 0
Australia
Phone 136288 0
+61 3 9246 8974
Fax 136288 0
Email 136288 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Non-identifiable data will be publicly available on public data repositories.

Conditions for requesting access:
• -

What individual participant data might 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.

What types of analyses could be done with individual participant data?
• Data will be available for any type of analyses.

When can requests for individual participant data be made (start and end dates)?
From:
Data will be available immediately after initial results have been published, with no end date.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Data will be available on the Open Science Framework (https://osf.io) and the Australian Data Archive (https://ada.edu.au). The PI of the current trial (Assoc. Prof. Elizabeth Westrupp) can be contacted for information regarding data sharing. Email: [email protected]


Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Basic resultsNo ANZCTR_basic_results_21.10.24.docx

Documents added automatically
No additional documents have been identified.