Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000363381
Ethics application status
Approved
Date submitted
12/01/2017
Date registered
10/03/2017
Date last updated
10/03/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Developmental Outcome of Children Assessed by the Child Development Unit Infant
Developmental Team at the Women's & Children's Hospital between January 2013 to
December 2014
Scientific title
Developmental Outcome of Children Assessed by the Child Development Unit Infant
Developmental Team at the Women's & Children's Hospital between January 2013 to
December 2014
Secondary ID [1] 290846 0
Nil
Universal Trial Number (UTN)
U1111-1191-3621
Trial acronym
Nil
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
Developmental Disorders/Delay/Difficulties
301522 0
Autism Spectrum Disorder 302399 0
Condition category
Condition code
Mental Health 301243 301243 0 0
Autistic spectrum disorders
Mental Health 301292 301292 0 0
Learning disabilities

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The Infant Development Team (IDT) at the Child Development Unit (CDU), Women's &
Children's Hospital provides a team approach to the assessment of babies and children
under three years who have developmental difficulties and provides support for their
families.

Parents/carers of children who were assessed by the Infant Development Team from January 2013 to December 2014 will be identified from the Child Development Unit database and will be sent a survey questionnaire attached with a research information sheet. Parents/carers are asked to complete the questionnaire and return the paperwork in a Reply Paid Envelope provided. Alternatively, an online version of the questionnaire can be completed. A study participant number will be assigned to the parent/carer and no identifiable information will be collected on the online form. This will be followed by a telephone inquiry if no response received within 4 weeks.

In most cases, children who were assessed by the IDT were discharged following their assessment. A proportion of these children were subsequently diagnosed with another medical condition or developmental condition. Some of these children were re-referred to the CDU when they were older for another assessment as they continued to have persisting developmental difficulties. The prevalence of persisting developmental concerns in this cohort of children is currently unknown. It is important to gain a better understanding of the prevalence of persisting developmental difficulties in these children, to allow better planning in relation to follow up and therapy needs, more successful transition to formal education, and to support family functioning.

Intervention code [1] 296785 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 300657 0
Overall developmental outcome of children who were assessed by the Infant Developmental Team in 2013 and 2014.

Method of measurement: Information provided by caregiver on current developmental status of child by method of Parent/Carer Questionnaire (Questionnaire was designed for this study and not previously validated)

Timepoint [1] 300657 0
2 to 3 years post assessment by the Infant Development Team (Children were assessed between January 2013 and December 2014)
Primary outcome [2] 300658 0
To determine the prevalence of persisting developmental difficulties in children who were assessed by the Infant Development Team who are now in the preschool or
early primary school age group.

Method of measurement: Information on current developmental status of their child provided by caregiver by method of Parent/Carer Questionnaire will be reviewed with information developmental assessment report by the Infant Development Team. This Questionnaire was designed for this study and not previously validated.

Timepoint [2] 300658 0
2 to 3 years post assessment by the Infant Development Team (Children who were assessed between January 2013 and December 2014)
Secondary outcome [1] 330657 0
To gain a better understanding regarding access to early intervention services and impediments to accessing these services.

Method of measurement: Information on current access to intervention services provided by caregivers by method of Parent/Carer Questionnaires will be reviewed. Intervention therapy recommendations made by the Infant Development Team will also be reviewed. This Questionnaire was designed for this study and not previously validated.
Timepoint [1] 330657 0
2 to 3 years post assessment by the Infant Development Team (Children who were assessed between January 2013 and December 2014)
Secondary outcome [2] 330658 0
To determine the necessity of follow up and aid future decision making of follow up practices of the Child Development Unit for this cohort of children.

Method of measurement: Information on preference for follow up practices provided by caregiver by method of Parent/Carer Questionnaire will be reviewed with information developmental assessment report by the Infant Development Team. This Questionnaire was designed for this study and not previously validated.

Timepoint [2] 330658 0
2 to 3 years post assessment by the Infant Development Team (Children who were assessed between January 2013 and December 2014)

Eligibility
Key inclusion criteria
Children who were assessed by the Infant Development Team between 1st January 2013 and 31st December 2014.
Minimum age
3 Years
Maximum age
6 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Parents/carers who do not consent for their child to participate in the study.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/12/2016
Date of last participant enrolment
Anticipated
12/03/2017
Actual
Date of last data collection
Anticipated
31/03/2017
Actual
Sample size
Target
67
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 7249 0
Womens and Childrens Hospital - North Adelaide
Recruitment postcode(s) [1] 15018 0
5006 - North Adelaide

Funding & Sponsors
Funding source category [1] 295308 0
Hospital
Name [1] 295308 0
Child Development Unit, Women's & Children's Hospital
Country [1] 295308 0
Australia
Primary sponsor type
Individual
Name
Dr Su Ling Chua
Address
Women's & Childrens Hospital
72 King William Road
North Adelaide
5006 SA
Country
Australia
Secondary sponsor category [1] 294133 0
Individual
Name [1] 294133 0
Dr Deepa Jeyaseelan
Address [1] 294133 0
Child Development Unit
Womens and Children's Hospital
72 King William Road
North Adelaide
5006 SA
Country [1] 294133 0
Australia
Secondary sponsor category [2] 294134 0
Individual
Name [2] 294134 0
Dr Deirdre White
Address [2] 294134 0
Child Development Unit
Women's & Children's Hospital
72 King William Road
North Adelaide
5006 SA
Country [2] 294134 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296638 0
Women's and Children's Hospital Human Research Ethics Committee
Ethics committee address [1] 296638 0
Ethics committee country [1] 296638 0
Australia
Date submitted for ethics approval [1] 296638 0
10/08/2016
Approval date [1] 296638 0
28/09/2016
Ethics approval number [1] 296638 0
HREC16/WCHN/132

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1348 1348 0 0
/AnzctrAttachments/368321-Ethics Approval_S_Chua_2016.pdf (Ethics approval)

Contacts
Principal investigator
Name 56342 0
Dr Su Ling Chua
Address 56342 0
Women's & Children's Hospital
72 King William Road
North Adelaide
5006 SA
Country 56342 0
Australia
Phone 56342 0
+61 8 81617000
Fax 56342 0
Email 56342 0
[email protected]
Contact person for public queries
Name 56343 0
Su Ling Chua
Address 56343 0
Women's & Children's Hospital
72 King William Road
North Adelaide
5006 SA
Country 56343 0
Australia
Phone 56343 0
+61 8 81617000
Fax 56343 0
Email 56343 0
[email protected]
Contact person for scientific queries
Name 56344 0
Su Ling Chua
Address 56344 0
Women's & Children's Hospital
72 King William Road
North Adelaide
5006 SA
Country 56344 0
Australia
Phone 56344 0
+61 8 81617000
Fax 56344 0
Email 56344 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.