Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000067471
Ethics application status
Approved
Date submitted
2/01/2025
Date registered
23/01/2025
Date last updated
16/02/2025
Date data sharing statement initially provided
23/01/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
The Intergenerational Wellbeing and Brain-Healthy Lifestyles Intervention (GenWell-BRAVE): A Feasibility Pilot
Scientific title
The Intergenerational Wellbeing and Brain-Healthy Lifestyles Intervention (GenWell-BRAVE): Pilot Feasibility in Older Adults and Preschool-Aged Children
Secondary ID [1] 313625 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
GenWell-BRAVE
Linked study record
This registration is for a sub-study of a RCT: ACTRN12623000127606

Health condition
Health condition(s) or problem(s) studied:
Dementia Risk 336404 0
Positive Mental Health 336182 0
Cognition 336181 0
Condition category
Condition code
Mental Health 332927 332927 0 0
Studies of normal psychology, cognitive function and behaviour
Public Health 332720 332720 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Both Group 1 (Intergenerational Program + Positive Mental Health) and Group 2 (Intergenerational Program) consist of 20 weeks of intergenerational sessions, at a dosage of 1x 2-hour session per week. In both groups, the intervention is delivered in a group format (bringing approximately 10 pre-school aged children and 10 older adults together), and within community pre-schools or associated spaces (e.g., connected halls).

The sessions of the 20-week program (hereafter: 'Intergenerational Practice Program' / IPP), in both Group 1 and Group 2, are based on the Early Years Learning Framework and allow adaptation to child and adult interests. Activities will require older adult and child participation, and can be adapted to suit physical limitations but also to stretch those who are more able. To standardise, each week is designed around meeting target “skills” (involving things like physical and cognitive activity), whilst maintaining focus on intergenerational collaboration. The IPP delivered to participants of the overarching INTEGRITY Trial is designed to be flexible, with no two weeks of activities the same. GenWell-BRAVE builds upon this by prescribing activities which target positive mental health (e.g., mindfulness, gratitude, savouring) within the IPP received by Group 1, and proscribing these activities for Group 2, to explore how they influence engagement and outcomes.

IPP sessions in both Groups will be facilitated under the purview of the INTEGRITY Trial. They are led by an early childhood educator who, at minimum, holds a Certificate 3 in Early Childhood Education. This educator will be trained on the protocol and IPP. A second early childhood educator employed at the preschool associated with a given cluster will also be present to ensure child wellbeing/safety, support the children in navigating the IPP, and assist in the flow of sessions. This educator must also have up-to-date early childhood accreditation. A maximum of two researchers or trained volunteers will also be present at each session to advise (e.g., protocol adherence), help set up/clear away, collect observation data, and/or monitor for safety (e.g., trip hazards).

Fidelity of implementation will be evaluated through recording of each session using a bespoke Target Domain & Dosage Checklist.

Participants in this trial will be drawn from clusters of the INTEGRITY Trial (ACTRN12623000127606 )which have been randomised to waitlist-control (i.e., participants currently providing data over a neutral window, but not during their receipt of the IPP). Clusters for GenWell-BRAVE will be a convenience sample of these sites, based on those who have IPPs being delivered during the GenWell-BRAVE timeframe (or until sample size is met). Additional consent will be sought from participants at these clusters for GenWell-BRAVE.
Intervention code [1] 330218 0
Prevention
Comparator / control treatment
The comparator in this study is Group 2. Group 2 is an Active Control in the context of this sub-study, and corresponds to the IPP typically delivered in the INTEGRITY Trial. Group 2 is identical in nature to Group 1 (described above), except activities targeting Positive Mental Health (e.g., mindfulness, gratitude, savouring) are proscribed.
Control group
Active

Outcomes
Primary outcome [1] 340247 0
Change in Cognition (Adults)
Timepoint [1] 340247 0
Baseline and End of Program (approximately 20 weeks post-baseline)
Secondary outcome [1] 443468 0
Adherence
Timepoint [1] 443468 0
Weekly during the IPP
Secondary outcome [2] 443467 0
Change in Positive Mental Health (Adults)
Timepoint [2] 443467 0
Baseline and End of Program (approximately 20 weeks post-baseline)
Secondary outcome [3] 443469 0
Retention
Timepoint [3] 443469 0
Study data will be maintained throughout the course of the trial, with records updated immediately when any instances of withdrawal or drop-out occur. At the completion of the IPP at any given site, study data will be evaluated to discern %Withdrawal/Drop-Out for the site.
Secondary outcome [4] 443471 0
Acceptability
Timepoint [4] 443471 0
End of Program (approximately 20 weeks post baseline)
Secondary outcome [5] 443470 0
Implementation Fidelity
Timepoint [5] 443470 0
Weekly during the IPP
Secondary outcome [6] 443472 0
Change in Emotion Regulation Capacity (Children)
Timepoint [6] 443472 0
Baseline and End of Program (approximately 20 weeks post baseline)

Eligibility
Key inclusion criteria
To be eligible to participate in GenWell-BRAVE, individuals need to meet the following criteria:
• Existing participant of the INTEGRITY Trial, who is enrolled in a site elected for the GenWell-BRAVE
Pilot.
• Be actively participating in follow-up testing for the INTEGRITY Trial.

Minimum age
3 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will not be eligible to participate, if the following criteria apply to them:
• Do not 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 will be concealed from participants and researchers involved in adjudicating the outcomes of the trial. Randomisation will be conducted centrally by computer, and at the cluster level. It will be concealed from relevant researchers using digitised methods (e.g., password protected documents).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Cluster randomisation using a randomisation table created by computer software. Clusters will be randomised for GenWell-BRAVE in temporal order of their follow-up testing date for the INTEGRITY Trial (i.e., prior to recruitment for GenWellBRAVE commencing at each cluster).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
GenWell-BRAVE intends to randomise 4 community-preschool clusters, with a target sample size of N = 80 [Adults, n = 40; Children, n = 40]. This target is based on a convenience sample of available INTEGRITY waitlist-control clusters, and feasible IPP enrolment rates. The target number of participants at each site (10 adults, 10 children), is determined by pre-school ratio requirements and best-practice guidelines for intergenerational practice which are indicative of a maximum 2:1 (child to adult) ratio for optimal program functioning. If recruitment uptake is low, GenWell-BRAVE maintains the option to adopt and randomise additional community-preschool clusters to support reaching desired sample size, provided these sites meet the project timeline. This sample size is therefore based on practical assumptions, for the purposes of pilot/feasibility testing.

Feasibility outcomes will be analysed and presented as summary statistics, mean and standard deviation for continuous approximately normally distributed data, median and inter quartile range for skewed continuous data and proportions for categorical data.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/03/2025
Actual
Date of last participant enrolment
Anticipated
31/10/2025
Actual
Date of last data collection
Anticipated
30/06/2026
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 318178 0
Government body
Name [1] 318178 0
National Health and Medical Research Council (NHMRC)
Country [1] 318178 0
Australia
Funding source category [2] 318246 0
University
Name [2] 318246 0
University of New South Wales (University Postgraduate Award)
Country [2] 318246 0
Australia
Primary sponsor type
Other
Name
The George Institute for Global Health
Address
Country
Australia
Secondary sponsor category [1] 320451 0
None
Name [1] 320451 0
Address [1] 320451 0
Country [1] 320451 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316740 0
The University of New South Wales Committee C
Ethics committee address [1] 316740 0
Ethics committee country [1] 316740 0
Australia
Date submitted for ethics approval [1] 316740 0
25/11/2024
Approval date [1] 316740 0
07/02/2025
Ethics approval number [1] 316740 0
iRECS5840

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

Contacts
Principal investigator
Name 138858 0
Dr Mei Ling Lim
Address 138858 0
The George Institute for Global Health Level 18, International Towers 3, 300 Barangaroo Ave, Barangaroo, NSW, 2000
Country 138858 0
Australia
Phone 138858 0
+61 280524330
Fax 138858 0
Email 138858 0
[email protected]
Contact person for public queries
Name 138859 0
April Mallon
Address 138859 0
The George Institute for Global Health Level 18, International Towers 3, 300 Barangaroo Ave, Barangaroo, NSW, 2000
Country 138859 0
Australia
Phone 138859 0
+61 280524330
Fax 138859 0
Email 138859 0
[email protected]
Contact person for scientific queries
Name 138860 0
Mei Ling Lim
Address 138860 0
The George Institute for Global Health Level 18, International Towers 3, 300 Barangaroo Ave, Barangaroo, NSW, 2000
Country 138860 0
Australia
Phone 138860 0
+61 280524330
Fax 138860 0
Email 138860 0
[email protected]

Data sharing statement
Will the study consider sharing 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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.