Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000519459
Ethics application status
Approved
Date submitted
9/01/2025
Date registered
23/05/2025
Date last updated
23/05/2025
Date data sharing statement initially provided
23/05/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Impact of the 2 to School model of care on health and development outcomes of urban Aboriginal children aged two to five years
Scientific title
Impact of the 2 to School model of care on health and development outcomes of urban Aboriginal children aged two to five years
Secondary ID [1] 313635 0
None
Universal Trial Number (UTN)
Trial acronym
2TS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Developmental learning disorder 336199 0
Obesity in children 336200 0
Condition category
Condition code
Diet and Nutrition 332733 332733 0 0
Obesity
Public Health 332734 332734 0 0
Health promotion/education
Mental Health 332735 332735 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
2toSchool is an individualised family-centred care planning approach designed to build a team around the family.
Materials: Materials are provided specific to the needs of the child/ren and/or parents/carers, and could include materials on healthy eating and physical activity, guidance on screen time, smoking cessation materials (such as “Quit for Life”), promotion of child development such as materials on Interactive-shared book reading strategies.
Procedures: Families receive child/ren and parent/carer need assessments conducted in narrative conversational form using the Family Partnership Model approach. When needed, child/ren and/or parent/carers are referred to social work and allied health providers.
Who: 2toSchool is delivered by an Aboriginal Health Education Officer with over 5 years’ experience in working with families with pre-school aged Aboriginal children.
Mode and location of delivery: In-person visits and/or video or phone engagement. In-person visits could be at the families’ homes or other venue including the health clinic, park or shopping centre. Mode and location of visit is determined by the families and general health recommendations during the global pandemic.
Duration and intensity: Families receive a minimum of four 60-minute visits per year (one visit very three months) for a minimum of one year. Additional visits could be scheduled in response to family and/or child need. Visits with social work and/or allied health providers are additional to the minimum four per year.
Intervention code [1] 330228 0
Prevention
Intervention code [2] 330229 0
Lifestyle
Intervention code [3] 330230 0
Behaviour
Comparator / control treatment
Outcomes were compared (where matching measures were used) with an historical no-intervention cohort of Aboriginal children and their families recruited from a large urban hospital in the neighbouring community between October 2005 and May 2007.
Control group
Historical

Outcomes
Primary outcome [1] 340261 0
Body mass index
Timepoint [1] 340261 0
On exit from the program, which is client/clinician determined based on need, and between at a minimum 12 months post-enrolment and maximum child entry into formal schooling.
Primary outcome [2] 340262 0
Child development
Timepoint [2] 340262 0
Baseline (on program entry) and end of program (between at a minimum 12 months post-enrolment and maximum child entry into formal schooling).
Primary outcome [3] 340263 0
Child social-emotional development
Timepoint [3] 340263 0
Baseline (on program entry) and end of program (between at a minimum 12 months post-enrolment and maximum child entry into formal schooling).
Secondary outcome [1] 443528 0
Household smoking
Timepoint [1] 443528 0
Baseline (on program entry) and end of program (between at a minimum 12 months post-enrolment and maximum child entry into formal schooling).
Secondary outcome [2] 443529 0
Child screen time
Timepoint [2] 443529 0
Baseline (on program entry) and end of program (between at a minimum 12 months post-enrolment and maximum child entry into formal schooling).
Secondary outcome [3] 443530 0
Warm/hostile parenting
Timepoint [3] 443530 0
Baseline (on program entry) and end of program (between at a minimum 12 months post-enrolment and maximum child entry into formal schooling).
Secondary outcome [4] 443531 0
Child reading
Timepoint [4] 443531 0
Baseline (on program entry) and end of program (between at a minimum 12 months post-enrolment and maximum child entry into formal schooling).
Secondary outcome [5] 447783 0
Child social-emotional development
Timepoint [5] 447783 0
Baseline (on program entry) and end of program (between at a minimum 12 months post-enrolment and maximum child entry into formal schooling).
Secondary outcome [6] 447784 0
Child physical activity
Timepoint [6] 447784 0
Baseline (on program entry) and end of program (between at a minimum 12 months post-enrolment and maximum child entry into formal schooling).

Eligibility
Key inclusion criteria
Families of Aboriginal children aged two years or older residing in South Western Sydney Local Health District area who are experiencing significant sustained adversity that either:
1) requires a multiservice and/or multiagency response (assessed as the child/ren and/or parent/carers having multiple health, social, emotional and/or developmental needs documented in their clinical records with the service, or as assessed at baseline; and who have
2) a history of poor service engagement assessed as having poor/late attendance for antenatal care for the 2toSchool child and/or at least two recorded instances of unexplained service non-attendance in the previous two years ; and
3) require a minimum of 12 months engagement to address their child's health and/or developmental concern as assessed by the referring clinician based on their clinical experience..
Minimum age
2 Years
Maximum age
5 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Child will commence school in less than 12 months.

Study design
Purpose of the study
Prevention
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
Other
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Pre-post study, using McNemar's test for comparing change in proportions for matched data, Chi-squared/Fisher-Freeman-Halton (FFH) exact test analysis for un-matched data, and paired t-test for matched parametric data. With the alpha set at 0.05, correlations between repeated measures set at 0.50, and power of 0.80, a total sample size of 45 participants was required.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
3/12/2018
Date of last participant enrolment
Anticipated
Actual
31/03/2022
Date of last data collection
Anticipated
Actual
28/04/2023
Sample size
Target
100
Accrual to date
Final
139
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 318104 0
Government body
Name [1] 318104 0
South Western Sydney Local Health District
Country [1] 318104 0
Australia
Primary sponsor type
Government body
Name
South Western Sydney Local Health District
Address
Country
Australia
Secondary sponsor category [1] 320464 0
University
Name [1] 320464 0
Western Sydney University
Address [1] 320464 0
Country [1] 320464 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316750 0
South Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 316750 0
Ethics committee country [1] 316750 0
Australia
Date submitted for ethics approval [1] 316750 0
30/08/2018
Approval date [1] 316750 0
07/01/2019
Ethics approval number [1] 316750 0
HE18/234
Ethics committee name [2] 316769 0
Aboriginal Health & Medical Research Council Ethics Committee
Ethics committee address [2] 316769 0
Ethics committee country [2] 316769 0
Australia
Date submitted for ethics approval [2] 316769 0
04/03/2019
Approval date [2] 316769 0
20/06/2019
Ethics approval number [2] 316769 0
1495/19

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

Contacts
Principal investigator
Name 138890 0
Ms Susanne Rigby
Address 138890 0
Hoxton Park Community Health, 596 Hoxton Park Rd, Hoxton Park NSW 2171
Country 138890 0
Australia
Phone 138890 0
+61 0484 668 260
Fax 138890 0
Email 138890 0
[email protected]
Contact person for public queries
Name 138891 0
Lynn Kemp
Address 138891 0
TReSI, Ingham Institute, 1 Campbell St Liverpool NSW 2170
Country 138891 0
Australia
Phone 138891 0
+61 2 87389386
Fax 138891 0
Email 138891 0
[email protected]
Contact person for scientific queries
Name 138892 0
Lynn Kemp
Address 138892 0
TReSI, Ingham Institute, 1 Campbell St Liverpool NSW 2170
Country 138892 0
Australia
Phone 138892 0
+61 2 87389386
Fax 138892 0
Email 138892 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
What individual participant data might be shared?
• De-identified individual participant data:
• Published results
What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
• Studies exploring new research questions
• Studies testing whether findings can be repeated or confirmed
• Teaching research methods or developing new statistical techniques
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
A finite period of: 7 years
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

• Postal address: Professor Lynn Kemp
TReSI, Ingham Institute
1 Campbell St
Liverpool NSW 2170
Australia

Are there extra considerations when requesting access to individual participant data?
Yes: Ethics approval from an appropriate Aboriginal or Torres Strait Islander human research ethics committee where available will be required for use of these data.



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.