Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000368730
Ethics application status
Approved
Date submitted
24/01/2022
Date registered
2/03/2022
Date last updated
12/12/2022
Date data sharing statement initially provided
2/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
INTERgenerAtional Clinical Trial In at risk Older adults and pre-school childreN (INTERACTION Trial)
Scientific title
Feasibility of INTERgenerAtional Clinical Trial In at risk Older adults and pre-school childreN (INTERACTION Trial)
Secondary ID [1] 305796 0
None
Universal Trial Number (UTN)
Trial acronym
INTERACTION Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Frailty 324303 0
Condition category
Condition code
Public Health 321791 321791 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The INTERgeneAtional Clinical-Trial In at-risk Older-adults and pre-school childreN (INTERACTION) is a two-site internal pilot trial to understand whether a community-based Intergenerational Practice (I-P) in preschool children and at-risk older adults is likely to be efficacious in reducing transition to frailty. This will be a 10-week trial of intergenerational practice at one site compared to a contemporaneous wait-list control at another site.

The I-P intervention consists of 10 weekly 2 hour sessions that will be delivered in church or community hall settings close to the participating pre-school sites. Each session brings together 10 children from the affiliated pre-school and 12 older adults from the local community. The nature of the Early Years Learning Framework and the importance of engaging both older adults and children mean that there is some flexibility as to the chosen activities. Each session must include at least one physical, one cognitive and one social activity, but the main focus may vary depending on the participants' preferences. The sessions include multi-modal intergenerational activities targeting physical, cognitive function and mood, and are tailored to the Early-Years Learning Framework. The activities are designed specifically for this study. Examples of activities include dancing, dress-up and role play and storytelling.

Sessions will be delivered by trained and experienced child educators supported by research staff familiar with working with older adults. All adults participating in or supporting the sessions are required to have a current working with children check.
Intervention code [1] 322192 0
Treatment: Other
Intervention code [2] 322193 0
Prevention
Comparator / control treatment
The control group is a contemporaneous wait-list control site that will recruit 10 children and 12 older adults the same way as the active site but will receive no intergenerational practice sessions during the research period. The wait-list control site will receive 10 weeks of intergenerational sessions after the end of their assessment (control) period. This is a best practice arrangement to reduce attrition.
Control group
Active

Outcomes
Primary outcome [1] 329557 0
Measures of recruitment and retention:
- number of participants screened, eligible, included (data will be retrieved from study records)
- attendance at intervention sessions (attendance of participants will be recorded for each session)
- reasons for ineligibility and lack of attendance (data will be retrieved from study records)
Timepoint [1] 329557 0
Throughout the intervention period
Secondary outcome [1] 402981 0
Older adults — Grip strength assessed using a Jamar dynamometer
Timepoint [1] 402981 0
Before week 1 of intervention (baseline) and after week 10 of intervention (post-intervention).
Secondary outcome [2] 403220 0
Older adults — Mood assessed using the Positive And Negative Affect Scale (PANAS)
Timepoint [2] 403220 0
Before week 1 of intervention (baseline) and after week 10 of intervention (post-intervention).
Secondary outcome [3] 403221 0
Older adults — Quality of life assessed using the Short Form 36 (SF-36)
Timepoint [3] 403221 0
Before week 1 of intervention (baseline) and after week 10 of intervention (post-intervention).
Secondary outcome [4] 403222 0
Older adults — Self-report of presence or absence of commonly occurring diagnoses relevant to aging
Timepoint [4] 403222 0
Before week 1 of intervention (baseline) and after week 10 of intervention (post-intervention).
Secondary outcome [5] 403223 0
Older adults — Mobility, balance and strength measures (Composite outcome) using the Short Physical Performance Battery test
Timepoint [5] 403223 0
Before week 1 of intervention (baseline) and after week 10 of intervention (post-intervention).
Secondary outcome [6] 403226 0
Older adults — Social engagement assessed using the Lubben Social Network Scale-6
Timepoint [6] 403226 0
Before week 1 of intervention (baseline) and after week 10 of intervention (post-intervention).
Secondary outcome [7] 403227 0
Older adults — Cognitive function (Sensorimotor function and comprehension) using the Cantab® Motor Screening Task (MOT) test
Timepoint [7] 403227 0
Before week 1 of intervention (baseline) and after week 10 of intervention (post-intervention).
Secondary outcome [8] 403228 0
Fear of falling assessed using the Iconographical Falls Efficacy Scale (IconFES)
Timepoint [8] 403228 0
Before week 1 of intervention (baseline) and after week 10 of intervention (post-intervention).
Secondary outcome [9] 403229 0
Child — Expressive language skills over 6 months assessed by Pearson’s Expressive Vocabulary test
Timepoint [9] 403229 0
Before week 1 of intervention (baseline) and after week 10 of intervention (post-intervention).
Secondary outcome [10] 403230 0
Child —Receptive language skills over 6 months assessed by Peabody Picture Vocabulary Test
Timepoint [10] 403230 0
Before week 1 of intervention (baseline) and after week 10 of intervention (post-intervention).
Secondary outcome [11] 405346 0
Child — Facial emotion recognition assessed using a normed database of facial expressions completed by children on a computer or paper-and-pencil version
Timepoint [11] 405346 0
Before week 1 of intervention (baseline) and after week 10 of intervention (post-intervention).
Secondary outcome [12] 406694 0
Child — Empathy and prosocial behaviour scores, on the brief 35-item parent-rating questionnaire Measure of Empathy in Early Childhood
Timepoint [12] 406694 0
Before week 1 of intervention (baseline) and after week 10 of intervention (post-intervention).
Secondary outcome [13] 406695 0
Older adults - Balance assessed using the near tandem balance test
Timepoint [13] 406695 0
Before week 1 of intervention (baseline) and after week 10 of intervention (post-intervention).
Secondary outcome [14] 406696 0
Older adults — Cognitive function (Multitasking) using the Cantab® Multitasking Test (MTT)
Timepoint [14] 406696 0
Before week 1 of intervention (baseline) and after week 10 of intervention (post-intervention).
Secondary outcome [15] 406697 0
Older adults — Cognitive function (Executive function) using the Cantab® One Touch Stockings of Cambridge (OTS) Test
Timepoint [15] 406697 0
Before week 1 of intervention (baseline) and after week 10 of intervention (post-intervention).
Secondary outcome [16] 406698 0
Older adults — Cognitive function (Working memory and strategy) using the Cantab® Spatial Working Memory (SWM) Test
Timepoint [16] 406698 0
Before week 1 of intervention (baseline) and after week 10 of intervention (post-intervention).
Secondary outcome [17] 406699 0
Older adults — Cognitive function (Processing and psychomotor speed) using the Cantab® Reaction Time (RTI) Test
Timepoint [17] 406699 0
Before week 1 of intervention (baseline) and after week 10 of intervention (post-intervention).
Secondary outcome [18] 406700 0
Older adults — Cognitive function (Sustained attention) using the Cantab® Rapid Visual Information Processing (RVP) Test
Timepoint [18] 406700 0
Before week 1 of intervention (baseline) and after week 10 of intervention (post-intervention).
Secondary outcome [19] 406701 0
Older adults — Cognitive function (Attention and visual searching) using the Cantab® Match to Sample Visual Search (MTS) Test
Timepoint [19] 406701 0
Before week 1 of intervention (baseline) and after week 10 of intervention (post-intervention).

Eligibility
Key inclusion criteria
Inclusion criteria for the older adults include:
• aged 65 or over
• with a baseline Montreal Cognitive Assessment score of 22 or more
• with a baseline frailty assessment within the pre-frail range on the FRAIL scale
• residing in the community (may be receiving aged-care but not residential nursing care)
• able to travel to the study site
• able to sit and stand from a chair with arms
• able to walk 6m with or without a walking aid
• fluent in English
• fully vaccinated against COVID-19
• who have provided informed consent to the video recording of interactions during the intergenerational sessions

Inclusion criteria for the children include:
• aged 3-5, and attending the preschool at the study site or an affiliated preschool
• fully toilet trained
• are able to follow instructions
• who have provided verbal assent and who’s parents have provided informed consent to their participation and to them being video recorded during the intergenerational sessions
Minimum age
3 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Key exclusion criteria for the older adults include:
• has speech or sensory deficits that prevent interaction
• does not have an up to date/valid working with children check

Key exclusion criteria for the children include:
• has challenging behaviors that may affect their ability to participate in the program

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
wait-list control design
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Descriptive statistics will be used to describe older adult and child participant populations.

The binary general health measures (e.g. diabetes Y/N) will be combined into a frailty index which provides a score between 0-1 (Searle et al 2008).

Cognitive scores will be converted to z-scores and averaged per cognitive domain and overall to provide a general measure of cognitive functioning.

The distributions of each continuous or quasi-continuous outcome variable (cognitive function, SF36 sub-scale scores, frailty index, grip strength etc.) will be examined and transformed where necessary.

Initial analyses comparing pre-post testing will use paired t-tests or Wilcoxon rank tests as appropriate.

Pre-post accuracy scores (% correct) from child assessments will also be compared.
Linear regression models will be used to evaluate change in outcome measures adjusted for baseline scores and sociodemographic variables (e.g. age, sex, educational level) in order to provide estimates of effect size for a future confirmatory large trial.

Video recordings of interactions between the participants will be coded to quantify the quality and reciprocal responsiveness of the relationships between the children and older adults at multiple timepoints throughout the 10-week session.

Planning for a subsequent trial and for potential future translation, will also be informed by data on source of recruitment (from community, word of mouth, social media, advertisements in clinic etc), eligibility, consent, and attrition rates.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2022
Actual
6/04/2022
Date of last participant enrolment
Anticipated
Actual
29/04/2022
Date of last data collection
Anticipated
Actual
1/11/2022
Sample size
Target
44
Accrual to date
Final
39
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 310149 0
Other Collaborative groups
Name [1] 310149 0
Mindgardens Neuroscience Network
Country [1] 310149 0
Australia
Primary sponsor type
Other
Name
Neuroscience Research Australia
Address
139 Barker Street
Randwick, New South Wales, Australia 2031
Country
Australia
Secondary sponsor category [1] 311224 0
None
Name [1] 311224 0
Address [1] 311224 0
Country [1] 311224 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309838 0
University of New South Wales Human Research Ethics & Clinical Trials Governance
Ethics committee address [1] 309838 0
Ethics committee country [1] 309838 0
Australia
Date submitted for ethics approval [1] 309838 0
22/11/2021
Approval date [1] 309838 0
31/01/2022
Ethics approval number [1] 309838 0

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

Contacts
Principal investigator
Name 115558 0
A/Prof Ruth Peters
Address 115558 0
Neuroscience Research Australia
139 Barker St, Randwick NSW 2031
Country 115558 0
Australia
Phone 115558 0
+61 290652866
Fax 115558 0
Email 115558 0
[email protected]
Contact person for public queries
Name 115559 0
Ruth Peters
Address 115559 0
Neuroscience Research Australia
139 Barker St, Randwick NSW 2031
Country 115559 0
Australia
Phone 115559 0
+61 290652866
Fax 115559 0
Email 115559 0
[email protected]
Contact person for scientific queries
Name 115560 0
Ruth Peters
Address 115560 0
Neuroscience Research Australia
139 Barker St, Randwick NSW 2031
Country 115560 0
Australia
Phone 115560 0
+61 290652866
Fax 115560 0
Email 115560 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.