Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000187347
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
29/01/2026
Date registered
Help: Date registered
13/02/2026
Date last updated
Help: Date last updated
13/02/2026
Date data sharing statement initially provided
Help: Data sharing statement date
13/02/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Acceptability and Feasibility Trial of a Digital Early Childhood Flourishing Intervention aimed at parents of children aged 0 – 5 years old
Scientific title
Acceptability and Feasibility Trial of a Digital Early Childhood Flourishing Intervention aimed at parents of children aged 0 – 5 years old
Additional trial identifiers [1] 316352 0
MRF2035649
Universal Trial Number (UTN)
U1111-1330-0181
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Childhood Mental Illness 340422 0
School readiness 340423 0
Condition category
Condition code
Mental Health 336629 336629 0 0
Anxiety
Mental Health 336630 336630 0 0
Depression
Public Health 336631 336631 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
The Flourishing Intervention

The Flourishing Child is a community co-designed intervention intended to empower parents to seek support for their child at the right time and place. Parents and carers of children aged 0-5 years will be randomly assigned to an intervention (n = 400) or waitlist control (n=200) group.

Components of the Intervention
The Flourishing Check (Hereafter referred to as “the Check”): A questionnaire assessing a child's level of flourishing across 6 domains, with 2 versions (for 0-2 years and 3-5 years).

The Pathway Tool: An online directory and information hub through which parents and carers can find high quality, evidence-based programs, services and resources that support early childhood flourishing. Examples include nearby playgroups (programs), child health nurse checks (services), and government endorsed parenting websites (resources).

The intervention group will receive access to the Pathway Tool after completing baseline assessment (T1) while the waitlist control group will receive access once data collection is complete (T5). Adherence to the intervention (e.g. use of the Pathway Tool) will be monitored at an aggregate level through website use metrics (e.g., number of external pages visited linking to resources and programs, number of resources saved, number of participant profiles created within the Pathway Tool).
The duration of each participant’s involvement in the study will be 6 to 7 months. Invitations to complete questionnaires at the final follow up time point will be sent out 6 months after study enrolment. This time point will remain open for one month with non-respondents being sent reminders to complete the questionnaires at 2 weeks and 4 weeks.
Intervention code [1] 333014 0
Prevention
Description of the comparator or control
An active control group will comprise participants who continue with standard care over the test period and receive access to the Pathway Tool at the completion of the study. Standard care will involve participants continuing their usual routines and practices without any additional intervention, changes, or special guidance beyond what they would normally do in everyday life.
Control group
Active

Outcomes
Primary outcome [1] 344139 0
Acceptability of the Flourishing Check.
Timepoint [1] 344139 0
T1 (baseline) and T4 (3 months after T1)
Primary outcome [2] 344140 0
Acceptability of the Pathway Tool
Timepoint [2] 344140 0
T2 (1 week after T1) and T4 (3 months after T1)
Primary outcome [3] 344265 0
Feasibility of the Flourishing Check
Timepoint [3] 344265 0
T1 (baseline), T3 (2 weeks after T1) and T4 (3 months after T1)
Secondary outcome [1] 456864 0
Feasibility of the Pathway Tool (This is an additional primary outcome)
Timepoint [1] 456864 0
T2 (1 week after T1) and T4 (3 months after T1)
Secondary outcome [2] 456865 0
Parent's perceived self-efficacy in recognising and supporting flourishing in early childhood
Timepoint [2] 456865 0
T1 (baseline) and T5 (6 months after T1)
Secondary outcome [3] 456866 0
Parent's perceived knowledge of how and when to seek support
Timepoint [3] 456866 0
T1 (baseline) and T5 (6 months after T1)
Secondary outcome [4] 457035 0
Parent's engagement with and participation in supports relevant to flourishing in the early years
Timepoint [4] 457035 0
T1 (baseline) and T5 (6 months after T1)
Secondary outcome [5] 457275 0
Parent wellbeing
Timepoint [5] 457275 0
T1 (baseline) and T5 (6 months after T1)
Secondary outcome [6] 457276 0
Pediatric quality of life
Timepoint [6] 457276 0
T1 (baseline) and T5 (6 months after T1)

Eligibility
Key inclusion criteria
Participants must [1] be parents or primary carers of at least one child aged 0-5 years and [2] reside within the metropolitan region of Perth Western Australia.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
Yes
Key exclusion criteria
Demographic quotas based on child age and sex will be used. Participants will be excluded if the quota bracket which they belong in has been filled.

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)
Randomisation stratified by child age and sex. Randomized using computer software (REDCap).
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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
13/02/2026
Actual
Date of last participant enrolment
Anticipated
1/07/2026
Actual
Date of last data collection
Anticipated
1/12/2026
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 320955 0
Government body
Name [1] 320955 0
Department of Health, Disability and Ageing - Medical Research Future Fund (Application ID: 2035649)
Country [1] 320955 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
The Kids Research Institute Australia
Address
Country
Australia
Secondary sponsor category [1] 323652 0
None
Name [1] 323652 0
Address [1] 323652 0
Country [1] 323652 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 319493 0
The University of Western Australia Human Research Ethics Committee
Ethics committee address [1] 319493 0
Ethics committee country [1] 319493 0
Australia
Date submitted for ethics approval [1] 319493 0
04/07/2025
Approval date [1] 319493 0
11/11/2025
Ethics approval number [1] 319493 0

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

Contacts
Principal investigator
Name 147502 0
Dr Jacqueline Davis
Address 147502 0
The Kids Research Institute Australia, 15 Hospital Avenue, Nedlands, Western Australia, 6009
Country 147502 0
Australia
Phone 147502 0
+61478173989
Fax 147502 0
Email 147502 0
[email protected]
Contact person for public queries
Name 147503 0
Jacqueline Davis
Address 147503 0
The Kids Research Institute Australia, 15 Hospital Avenue, Nedlands, Western Australia, 6009
Country 147503 0
Australia
Phone 147503 0
+61863191000
Fax 147503 0
Email 147503 0
[email protected]
Contact person for scientific queries
Name 147504 0
Jacqueline Davis
Address 147504 0
The Kids Research Institute Australia, 15 Hospital Avenue, Nedlands, Western Australia, 6009
Country 147504 0
Australia
Phone 147504 0
+61863191000
Fax 147504 0
Email 147504 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Due to the sensitive nature of the data being collected, data will not be shared at the individual participant level



What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Other    Participant information brochure The Flourishing Child - PIB - Web.pdf


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.