None listed
Conditions
Brief summary
GenWell-BRAVE is a SWAT (“Study Within a Trial”) of a large-scale NHMRC funded Clinical Trial, “The INTEGRITY Trial.” The INTEGRITY Trial aims to deliver an Intergenerational Practice Program (IPP) to 44 community pre-schools across Greater Sydney and evaluate the impact of the intervention on reducing frailty in community-dwelling older adults and improving the developmental skills of pre-school aged children. This preventative interventional approach, underscored by masses of public interest, may similarly be applied as a lifestyle approach for dementia risk reduction. There has recently been a growing awareness of the pivotal role psychological states play in health behaviours, and combating lifestyle-driven disease risk. It is additionally increasingly becoming recognised that positive psychological states (i.e., "Positive Mental Health') have a distinct protective effect on cognition, brain-health behaviours, and dementia incidence. As such, it is viable that targeting Positive Mental Health in lifestyle interventions to reduce dementia risk may be a vital ingredient for effectiveness. Leveraging several waitlist-control clusters of The INTEGRITY Trial, the present pilot addresses this rising evidence by exploring the impact of delivering an IPP with activities informed by positive psychological intervention (PPI), compared to a standard practice IPP. The GenWell-BRAVE pilot will explore whether this pro/prescription of PPI activities, results in any deviations in feasibility and/or on changing the dementia risk profile (i.e., cognitive trajectories and risk factor engagement) of adult participants.
Interventions
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 Practi
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.
Sponsors
The George Institute for Global Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Investigator)
Eligibility
Sex/Gender
All
Age
3 Years to No maximum
Healthy volunteers
Yes
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.
Exclusion criteria
Participants will not be eligible to participate, if the following criteria apply to them: • Do not provide informed consent.
Outcome results
None listed