Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000553370
Ethics application status
Approved
Date submitted
31/03/2017
Date registered
20/04/2017
Date last updated
19/04/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Ages and Stages Questionnaire - Talking about raising Aboriginal Kids (ASQ-TRAK) developmental screening tool for Australian Aboriginal children. Determining the reliability and face validity of the ASQ-TRAK and exploring the characteristics of developmental delay in Aboriginal children in urban, regional and remote areas of South Australia.
Scientific title
The ASQ-TRAK developmental screening tool for Australian Aboriginal children. Determining the reliability and face validity of the ASQ-TRAK and exploring the characteristics of developmental delay in Aboriginal children in urban, regional and remote areas of South Australia.
Secondary ID [1] 291571 0
Nil known
Universal Trial Number (UTN)
1111-1194-9000
Trial acronym
Linked study record
D’Aprano A, Silburn S, Johnston V, Robinson G, Oberklaid F & Squires J. Adaptation of the Ages and Stages Questionnaire for Remote Aboriginal Australia. Qualitative Health Research. 2016 April; 26 (5): 613-25.

Simpson, S, D'Aprano, A, Tayler, C, Khoo, ST, Highfold, R. Validation of a culturally adapted developmental screening tool for Australian Aboriginal children: Early findings and next steps. Early Human Development. 2016;103:91–95.

Health condition
Health condition(s) or problem(s) studied:
Developmental delay 302688 0
Condition category
Condition code
Mental Health 302218 302218 0 0
Learning disabilities
Mental Health 302219 302219 0 0
Studies of normal psychology, cognitive function and behaviour
Public Health 302220 302220 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study will be using a new developmental screening tool (the ASQ-TRAK) to observe the characteristics of normal childhood development and any deviation from normal childhood development in a cohort of Australian Aboriginal children. Each child is likely to be observed on one occasion only however as the trial will be conducted over a 12 month period it is possible that a child may be observed on 2 or 3 occasions over this time. The ASQ-TRAK is a developmental screening tool that was developed in consultation with Aboriginal communities in the Northern Territory in Australia. It is based on the Ages and Stages Questionnaire 3 (ASQ-3) which is a widely used developmental screening tool that has been validated in the United States and demonstrated feasibility and acceptability across a number of different cultures and language groups.

Whilst the ASQ-3 has been validated in the United States it has not been validated for use in Australian Aboriginal people. To date, no developmental screening tool exists that has been validated for use for Aboriginal people. The ASQ-TRAK tool was modified from the existing ASQ-3 as part of a pHD project completed by Dr Anita D'Aprano. The project involved taking the ASQ-3 and having meetings and interviews with community representatives (of 2 remote Indigenous communities in the Northern Territory), early childhood experts and linguists as to how the tool could be changed to be more culturally appropriate and relevant for Aboriginal people. Questions were changed to be more culturally relevant and the English used was altered to be simpler and easier to understand. The ASQ-TRAK was then translated into the languages of the 2 communities where the initial study was undertaken and each question was illustrated to help with understanding the question.

The observation for study participants consists of a number of questions, tasks and games that the child undertakes. The tool is designed so that the question, task or game is administered by the parent or caregiver with support from the worker. The tool consists of five domains; communication, fine motor, gross motor, problem solving and personal-social. These domains are assessed in a variety of ways and may include observing how the child talks or communicates, asking the child to stack blocks or draw a picture, observing how a child moves or asking them to jump or catch a ball, observing how a small child may work to retrieve an object out of reach or an older child about concepts such as "big" and "small" and asking a parent about the ways in which a child plays or interacts with people. After each observation the parent or guardian will be asked to complete a questionnaire in order to evaluate what the parents think about the tools usefulness, acceptability and whether it is felt to be culturally appropriate and respectful.

A child may be observed more than once for a number of reasons. Aboriginal children who present to Child and Family Health Services (CaFHS) at any of 4 locations will be approached regarding the study. For the children presenting to the urban and regional sites (but not the remote site) each family will be asked firstly if they consent to take part and then if they would be willing to have the screen re-administered within a 2 week period. The repeat screen could be administered by the same or a different staff member as determined by staff availability. This information will be used to determine intra and inter-observer reliability for the tool. Also, as the trial will run over a 12 month period the same child may be observed at different points of time (and therefore with a different age group questionnaire). I. For example it is routine for CaFHS to encourage parents to present for developmental screening at 6 months of age and at 18 months of age. Therefore a child who, by chance, is 6 months of age at the commencement of the study would be quite likely to be observed on 2 occasions. It is possible that a child for whom there are greater developmental concerns would be offered a developmental screen more frequently and therefore be observed on 3 or more occasions. Any child or family who refuses consent for the trial will be offered developmental screening using the ASQ-3 as is consistent with existing guidelines.

The assessments will be performed by a small group of workers who have been trained in how to use the tool, via a 2 day workshop and a practical, workplace based assessment. These workers will either be nurses or Aboriginal health workers with CaFHS. Each observation is likely to take around 45 mins with an extra 10 minutes required in order to complete the parent feedback questionnaire. The assessments are observational in nature however the results of the assessments will be used to guide whether further evaluation of development is required, this would be via referral to a paediatrician or allied health practitioners such as speech pathologists or occupational therapists as is appropriate.

Earlier studies of the ASQ-TRAK showed high face validity and the tool was considered to be culturally acceptable and relevant to Aboriginal parents, Aboriginal Health Workers and early childhood development experts in the Northern Territory.
Intervention code [1] 297641 0
Early detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 301617 0
Establish the reliability of the ASQ-TRAK including internal consistency.

Internal consistency of ASQ-TRAK items will be analysed using Cronbachs alpha calculations. A single ASQ-TRAK assessment is all that is required to perform these calculations of correlations between items within a single scale and with the overall scale score.
Timepoint [1] 301617 0
6 months after completing data collection
Primary outcome [2] 301668 0
Establish the reliability of the ASQ-TRAK including test-retest reliability.

Test-retest reliability will be assessed by administering the ASQ-TRAK twice with a child, by the same examiner, within a 1-2 week period. Results will be analysed using intraclass correlation coefficients.
Timepoint [2] 301668 0
6 months after the completion of data collection
Primary outcome [3] 301669 0
Establish the reliability of the ASQ-TRAK including interobserver reliability.

Inter-rater reliability will be assessed by administering the ASQ-TRAK twice with a child, by two different examiners, within a 1-2 week period. Results will be analysed using intraclass correlation coefficients.
Timepoint [3] 301669 0
6 months after the completion of data collection
Secondary outcome [1] 333350 0
Establish the prevalence of developmental difficulties in the study cohort.

This will be assessed using the ASQ-TRAK results both overall and each subscale.
Timepoint [1] 333350 0
6 months after completion of data collection
Secondary outcome [2] 333516 0
Establish the face validity of the ASQ-TRAK, from the perspectives of the child health practitioners in urban South Australia using the staff questionnaire.

The staff questionnaire was designed for the purposes of this study.
Timepoint [2] 333516 0
6 months after the completion of data collection
Secondary outcome [3] 333517 0
Establish the face validity of the ASQ-TRAK, from the perspectives of caregivers in urban South Australia using the carer questionnaire.

The staff questionnaire was designed for the purposes of this study.
Timepoint [3] 333517 0
6 months after the completion of data collection
Secondary outcome [4] 333518 0
Establish the face validity of the ASQ-TRAK, from the perspectives of the child health practitioners in regional South Australia using the staff questionnaire.

The staff questionnaire was designed for the purposes of this study.
Timepoint [4] 333518 0
6 months after the completion of data collection
Secondary outcome [5] 333519 0
Establish the face validity of the ASQ-TRAK, from the perspectives of child health practitioners in remote areas of South Australia using the staff questionnaire.

The staff questionnaire was designed for the purposes of this study.
Timepoint [5] 333519 0
6 months after the completion of data collection
Secondary outcome [6] 333521 0
Establish the face validity of the ASQ-TRAK, from the perspectives of caregivers in regional South Australia using the carer questionnaire.

The staff questionnaire was designed for the purposes of this study.
Timepoint [6] 333521 0
6 months after the completion of data collection
Secondary outcome [7] 333522 0
Establish the face validity of the ASQ-TRAK, from the perspectives of caregivers in remote areas of South Australia using the carer questionnaire.

The staff questionnaire was designed for the purposes of this study.
Timepoint [7] 333522 0
6 months after the completion of data collection

Eligibility
Key inclusion criteria
Aboriginal children aged 2, 6, 12, 18, 24, 36 or 48 months who attend any of the four Child and Family Health Service (CaFHS) sites (Port Adelaide, Morphett Vale, Port Augusta and Anangu Pitjantjatjara Yankunytjatjara (APY) Lands
Minimum age
1 Months
Maximum age
4 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
The ASQ-TRAK has been developed for children aged 2, 6, 12, 18, 24, 36 and 48 months with a specified age criteria to use each of these questionnaires (eg. 2 month questionnaire is valid from 1 month to 2 months and 30 days). If children should fall out of the specified age range they will be excluded from the trial . These children will be offered an ASQ-III to assess their development as is current procedure.
Children will also be excluded from the study if they do not reside within the specified areas of the trial and if they are not Aboriginal.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
Descriptive statistics will be used to analysis demographic data and participant characteristics.
We will also employ qualitative analysis of the parent and staff questionnaire information.
Further, analysis of the primary outcome (identification of proven developmental delay) will occur at the individual infant level and will use multivariate logistic regression. Similar techniques will be used for comparison of acceptability and reliability.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
24/04/2017
Actual
10/04/2017
Date of last participant enrolment
Anticipated
6/04/2018
Actual
10/04/2018
Date of last data collection
Anticipated
13/04/2018
Actual
10/04/2018
Sample size
Target
160
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 15678 0
5162 - Morphett Vale
Recruitment postcode(s) [2] 15679 0
5015 - Port Adelaide
Recruitment postcode(s) [3] 15680 0
5700 - Port Augusta
Recruitment postcode(s) [4] 15681 0
0872 - Amata

Funding & Sponsors
Funding source category [1] 296061 0
Government body
Name [1] 296061 0
SA health - government department of health. Women's and Children's Health Service; Child and Family Health Service (CaFHS)
Country [1] 296061 0
Australia
Primary sponsor type
Government body
Name
SA Health - government department of health. Women's and Children's Health Network; Child and Family Health Service (CaFHS)
Address
Child and Family Health Service
295 South Tce
Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 294951 0
None
Name [1] 294951 0
Address [1] 294951 0
Country [1] 294951 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297317 0
Aboriginal Health Research Ethics Committee
Ethics committee address [1] 297317 0
Ethics committee country [1] 297317 0
Australia
Date submitted for ethics approval [1] 297317 0
15/11/2016
Approval date [1] 297317 0
01/12/2016
Ethics approval number [1] 297317 0
04-16-702
Ethics committee name [2] 297326 0
Women's and Children's Health Network Human Research Ethics Committee
Ethics committee address [2] 297326 0
Ethics committee country [2] 297326 0
Australia
Date submitted for ethics approval [2] 297326 0
23/11/2016
Approval date [2] 297326 0
08/02/2017
Ethics approval number [2] 297326 0
HREC/16/WCHN/185
Ethics committee name [3] 297327 0
University of Melbourne Central Human Research Ethics Committee
Ethics committee address [3] 297327 0
Ethics committee country [3] 297327 0
Australia
Date submitted for ethics approval [3] 297327 0
15/02/2017
Approval date [3] 297327 0
Ethics approval number [3] 297327 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1613 1613 0 0
/AnzctrAttachments/372657-Protocol.docx (Protocol)
Attachments [2] 1614 1614 0 0
/AnzctrAttachments/372657-Participantinformation.docx (Participant information/consent)
Attachments [3] 1615 1615 0 0
/AnzctrAttachments/372657-WCHNHRECapproval.pdf (Ethics approval)
Attachments [4] 1616 1616 0 0
/AnzctrAttachments/372657-AHREC Approval.pdf (Ethics approval)
Attachments [5] 1620 1620 0 0
/AnzctrAttachments/372657-ASQ-TRAK WCHN Parent Questionnaire.docx (Supplementary information)
Attachments [6] 1621 1621 0 0
/AnzctrAttachments/372657-ASQ-TRAK WCHN CaFHS staff Questionnaire.docx (Supplementary information)

Contacts
Principal investigator
Name 73686 0
Dr Deepa Jeyaseelan
Address 73686 0
Child Development Unit
Women's and Children's Hospital
72 King William Rd
North Adelaide
SOUTH AUSTRALIA
5006
Country 73686 0
Australia
Phone 73686 0
+61 881617000
Fax 73686 0
Email 73686 0
[email protected]
Contact person for public queries
Name 73687 0
Deepa Jeyaseelan
Address 73687 0
Child Development Unit
Women's and Children's Hospital
72 King William Rd
North Adelaide
SOUTH AUSTRALIA
5006
Country 73687 0
Australia
Phone 73687 0
+61 881617000
Fax 73687 0
Email 73687 0
[email protected]
Contact person for scientific queries
Name 73688 0
Deepa Jeyaseelan
Address 73688 0
Child Development Unit
Women's and Children's Hospital
72 King William Rd
North Adelaide
SOUTH AUSTRALIA
5006
Country 73688 0
Australia
Phone 73688 0
+61 881617000
Fax 73688 0
Email 73688 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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