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The INTErGenerational intervention taRgeting fraIlTY trial (INTEGRITY)

The INTErGenerational intervention taRgeting fraIlTY trial (INTEGRITY): A randomised wait-list controlled trial in older adults and preschool children

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623000127606
Acronym
INTEGRITY
Enrollment
599
Registered
2023-02-07
Start date
2023-02-14
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Frailty has been described as the ‘public health crisis for an ageing society’. As many as 24% of older Australians are frail, with heightened vulnerability and susceptibility to stressors, and growing economic and societal costs. The recent ABC TV show ‘Old People’s Home for Four Year Olds’ has shown on-screen benefits from a non-familial intergenerational practice – by bringing together community-dwelling older adults and pre-schoolers to reduce the older adults frailty. The shows popularity has lead communities around Australia to instigate similar intergenerational programs. However, our recent systematic review finds only small-scale, largely qualitative evidence for such intergenerational practice. Given the potential benefit at low interventional cost, we now urgently need to establish whether (and to what degree) intergenerational practice effectively reduces frailty in our aging population. To do this, the INTErGenerational Intervention to taRget fraIlTY (INTEGRITY) trial extends our pilot trials to rigorously test an intergenerational practice program using a cluster randomised, blinded endpoints clinical trial bringing older adults and preschool children together in 44 clusters. Frailty measures collected from clusters randomised to receive an intergenerational practice intervention or wait list control will be compared. Secondary outcomes include self-reported older adult health and quality of life, child language and empathy measures. We hypothesised that participating in a 20-week intergernerational program will prevent frailty, improve older adults' health and quality of life, and improve the children's developmental skills. The community-based INTEGRITY trial has been co-conceived and co-designed with a community and stakeholder team and will establish the first robust evidence for community based intergenerational practice. These results will help improve and inform both current and future practice programs. We will also use our learning from the trial to build an accessible online guide for communities wishing to run intergenerational activities.

Interventions

The intervention consists of 20 weeks of intergenerational sessions with one 2-hour session a week with 10 older adults and 10 preschool children at each participating preschool. The 20 weeks are divided into 2 school terms (10 weeks each) with a 2 weeks school holidays/term break between the school terms. The sessions are led by two preschool educators (at least one of whom must have an up-to-date accreditation in early child education at Diploma or Degree level) trained to deliver intergenera

The intervention consists of 20 weeks of intergenerational sessions with one 2-hour session a week with 10 older adults and 10 preschool children at each participating preschool. The 20 weeks are divided into 2 school terms (10 weeks each) with a 2 weeks school holidays/term break between the school terms. The sessions are led by two preschool educators (at least one of whom must have an up-to-date accreditation in early child education at Diploma or Degree level) trained to deliver intergenerational content (the research team will provide training). A researcher or trained volunteer will also be present at each session to help advise and to help set up/clear away and monitor the room for safety issues – e.g., items on the floor that could cause a trip hazard. The sessions are based within the Early Years Learning Framework and allow for adaptation to child and adult interests. Each week begins with a welcome song with associated actions and movement then 2 hours of themed activities that include at least 15 minutes of moderate activity in the first 10 weeks rising to 30 minutes in the last 10 weeks plus at least 15 minutes of light activity. The intensity of activity will be based on recommendation by physical activity expert from the research team (i.e. physiotherapist and exercise physiologist). Also included each week are tasks that require executive function, memory (recall and recognition), attention and language. Examples of cognitive tasks include, egg and spoon game and food memory game. Each physical or cognitive task will require older adult and child participation and can be adapted to suit different physical limitations or to stretch those who are more able. Examples of exercise and/or physical tasks modified captain's ball, balloon relay race and dancing. Each week must also contain tasks that require older adult and children collaboration and social engagement. The researcher or trained volunteer who attended the session will play an active part in the reflection and support the preschool educators in planning the subsequent week. Session attendance of each participant will also be measured using the attedance list.

Sponsors

The George Institute for Global Health
Lead SponsorOther

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
3 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Inclusion criteria for adults: • aged 65 or over • able to walk approximately 6m with or without a walking aid (self-reported) • able to sit and stand from a chair with arms • a baseline Telephone Montreal Cognitive Assessment score of 19 or more • residing in the community (may be receiving aged care at home but not residing in residential aged care) • Fully vaccinated against COVID or other current infectious disease in accordance with current guidelines at the time of the trial • Written/digital informed consent Inclusion criteria for children: • aged 3-4 • attending the preschool at the study site or an affiliated preschool • not attending school the next year • fully toilet trained • who have provided verbal assent • where parents/guardians have provided written informed consent • Fully vaccinated against COVID-19 or other current infectious disease in accordance with current requirements at the time of the trial Inclusion criteria for educators: • Be a qualified pre-school educator at one of the participating pre-schools

Exclusion criteria

Key exclusion criteria for adults: • has speech or sensory deficits that prevent interaction • does not have an up to date/valid working with children check Key exclusion criteria for children: • has challenging behaviors that may affect their ability to participate in the program Key exclusion criteria for educators: • not familiar with the children who are participating in the research project

Outcome results

None listed

Source: ANZCTR · Data processed: Jul 3, 2026