Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
Please note that the ANZCTR website will be unavailable from 1:00pm until 2:30pm (AEST) on Thursday 5th June for website maintenance.
Please be sure to log out of the system in order to avoid any loss of data. Thank you and apologies for any inconvenience caused.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
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
Query!
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
Query!
Secondary ID [1]
313635
0
None
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
2TS
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Developmental learning disorder
336199
0
Query!
Obesity in children
336200
0
Query!
Condition category
Condition code
Diet and Nutrition
332733
332733
0
0
Query!
Obesity
Query!
Public Health
332734
332734
0
0
Query!
Health promotion/education
Query!
Mental Health
332735
332735
0
0
Query!
Studies of normal psychology, cognitive function and behaviour
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
330228
0
Prevention
Query!
Intervention code [2]
330229
0
Lifestyle
Query!
Intervention code [3]
330230
0
Behaviour
Query!
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.
Query!
Control group
Historical
Query!
Outcomes
Primary outcome [1]
340261
0
Body mass index
Query!
Assessment method [1]
340261
0
Clinician measured child height (stadiometer) and weight (digital scales).
Query!
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.
Query!
Primary outcome [2]
340262
0
Child development
Query!
Assessment method [2]
340262
0
Clinician assessed Ages and Stages Questionnaire version 3 (ASQ-3)
Query!
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).
Query!
Primary outcome [3]
340263
0
Child social-emotional development
Query!
Assessment method [3]
340263
0
Clinician assessed Ages and Stages Questionnaire: Social Emotional (ASQ:SE)
Query!
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).
Query!
Secondary outcome [1]
443528
0
Household smoking
Query!
Assessment method [1]
443528
0
Parent report survey designed for this study
Query!
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).
Query!
Secondary outcome [2]
443529
0
Child screen time
Query!
Assessment method [2]
443529
0
Parent report survey designed for this study
Query!
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).
Query!
Secondary outcome [3]
443530
0
Warm/hostile parenting
Query!
Assessment method [3]
443530
0
Parent report survey questions from the Longitudinal Study of Australian Children
Query!
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).
Query!
Secondary outcome [4]
443531
0
Child reading
Query!
Assessment method [4]
443531
0
Parent report survey designed for this study
Query!
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).
Query!
Secondary outcome [5]
447783
0
Child social-emotional development
Query!
Assessment method [5]
447783
0
Parent report survey Strengths and Difficulties Questionnaire (SDQ)
Query!
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).
Query!
Secondary outcome [6]
447784
0
Child physical activity
Query!
Assessment method [6]
447784
0
Parent report survey designed for this study
Query!
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).
Query!
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..
Query!
Minimum age
2
Years
Query!
Query!
Maximum age
5
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
Child will commence school in less than 12 months.
Query!
Study design
Purpose of the study
Prevention
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Other
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Efficacy
Query!
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.
Query!
Recruitment
Recruitment status
Completed
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
3/12/2018
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
31/03/2022
Query!
Date of last data collection
Anticipated
Query!
Actual
28/04/2023
Query!
Sample size
Target
100
Query!
Accrual to date
Query!
Final
139
Query!
Recruitment in Australia
Recruitment state(s)
NSW
Query!
Funding & Sponsors
Funding source category [1]
318104
0
Government body
Query!
Name [1]
318104
0
South Western Sydney Local Health District
Query!
Address [1]
318104
0
Query!
Country [1]
318104
0
Australia
Query!
Primary sponsor type
Government body
Query!
Name
South Western Sydney Local Health District
Query!
Address
Query!
Country
Australia
Query!
Secondary sponsor category [1]
320464
0
University
Query!
Name [1]
320464
0
Western Sydney University
Query!
Address [1]
320464
0
Query!
Country [1]
320464
0
Australia
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
316750
0
South Western Sydney Local Health District Human Research Ethics Committee
Query!
Ethics committee address [1]
316750
0
https://www.swslhd.health.nsw.gov.au/ethics/
Query!
Ethics committee country [1]
316750
0
Australia
Query!
Date submitted for ethics approval [1]
316750
0
30/08/2018
Query!
Approval date [1]
316750
0
07/01/2019
Query!
Ethics approval number [1]
316750
0
HE18/234
Query!
Ethics committee name [2]
316769
0
Aboriginal Health & Medical Research Council Ethics Committee
Query!
Ethics committee address [2]
316769
0
https://www.ahmrc.org.au/ethics-at-ahmrc/
Query!
Ethics committee country [2]
316769
0
Australia
Query!
Date submitted for ethics approval [2]
316769
0
04/03/2019
Query!
Approval date [2]
316769
0
20/06/2019
Query!
Ethics approval number [2]
316769
0
1495/19
Query!
Summary
Brief summary
The aim of project is to determine whether multi-component intervention in early childhood (i.e. sustained nurse home visiting from pregnancy to age 2, needs-based interventions from age 2 to school entry, early education) improves health, development and transition to school of Aboriginal children. The evaluation will utilise a mixed method design to gather administrative, parent report and standard measures as well as qualitative and audit data. Effectiveness of a program of intervention and support for Aboriginal children will be based on comparisons, adjusted for baseline differences, with an historical cohort of Aboriginal children not receiving structured intervention Population child health, development and early education data from other sources Expected outcomes of the program are to: - Improve health and development outcomes for Aboriginal children, and - ‘Close the Gap’ between outcomes for Aboriginal and non-Aboriginal children.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
2toSchool commenced implementation as a model of care within the service in late 2018, with routine service data collection. Simultaneously, the service discussed conducting a formal, external evaluation of the project with the university partner who commenced the ethics approval processes to both extract and analyse the existing service data with the consent of the service receiving families, as well as extract the subsequent end of program data. The full ethics permission for the university to seek service clients' consent to extract their extant service recorded data and end of program data was received in June 2019. All 2toSchool service users receiving the service at that time were contacted to seek consent to use their data. All subsequently enrolled service users were consented as part of the service enrolment processes.
Query!
Contacts
Principal investigator
Name
138890
0
Ms Susanne Rigby
Query!
Address
138890
0
Hoxton Park Community Health, 596 Hoxton Park Rd, Hoxton Park NSW 2171
Query!
Country
138890
0
Australia
Query!
Phone
138890
0
+61 0484 668 260
Query!
Fax
138890
0
Query!
Email
138890
0
[email protected]
Query!
Contact person for public queries
Name
138891
0
Lynn Kemp
Query!
Address
138891
0
TReSI, Ingham Institute, 1 Campbell St Liverpool NSW 2170
Query!
Country
138891
0
Australia
Query!
Phone
138891
0
+61 2 87389386
Query!
Fax
138891
0
Query!
Email
138891
0
[email protected]
Query!
Contact person for scientific queries
Name
138892
0
Lynn Kemp
Query!
Address
138892
0
TReSI, Ingham Institute, 1 Campbell St Liverpool NSW 2170
Query!
Country
138892
0
Australia
Query!
Phone
138892
0
+61 2 87389386
Query!
Fax
138892
0
Query!
Email
138892
0
[email protected]
Query!
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.
Download to PDF