Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000083897
Ethics application status
Approved
Date submitted
16/01/2012
Date registered
17/01/2012
Date last updated
17/01/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
The Behavioural and Emotional Wellbeing of four year olds before and after the Canterbury earthquakes: A pre and post disaster study of changes in the Strengths and Difficulties Questionnaire (SDQ) in preschoolers.
Scientific title
A population based observational study of the emotional and behavioural wellbeing of Canterbury four year old children before and after the Canterbury earthquakes: a pre and post disaster study of changes in the Strengths and Difficulties Questionnaire (SDQ) in preschoolers
Secondary ID [1] 279732 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Emotional Wellbeing in children 285589 0
Child behaviour 285590 0
Condition category
Condition code
Mental Health 285784 285784 0 0
Other mental health disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The B4 School check is the final Well Child Check. It is offered to all children in New Zealand when they turn 4 years of age. The B4 School Check comprises 9 health screens: Child Health, Dental, Growth, Immunisation, Parental Evaluation of Development (PEDS), Strengths and Difficulties (SDQ) Parent & Teacher, and Vision and Hearing testing. The B4 school check was introduced in mid 2008 and has been offered since this time. Data from this has been collated in the National B4 school check data base since commencement of the check. This time period incorporates the period before September 2010, and data has continued to be collected since this time including across the Canterbury region since the earthquakes.
This is an observational study of changes in the scores on the SDQ of children in Canterbury region pre and post the Canterbury earthquakes using data from the National B4 school check database.
Intervention code [1] 283890 0
Not applicable
Comparator / control treatment
Data for the Canturbury region from the National B4 school check database will be analysed with comparisons of data from prior to the Canterbury earthquakes (data from january 2009 until september 3 2010) made with data from time periods following each of the major earthquakes (4/11/2010 and 22/02/2011). Scores on both the parent and teacher SDQ will be considered.
Control group
Historical

Outcomes
Primary outcome [1] 286291 0
The primary aim of this study is to use the already collected National database information to provide a global community measure of emotional and behavioural wellbeing in Canterbury 4 year olds before, during and after the 2010/2011 earthquakes. This will be measured by changes in the Strengths and Difficulties Questionnaire (SDQ) total score and impact scores over time. Both teacher and parent versions will be compared.
Timepoint [1] 286291 0
The primary timepoints considered will be baseline (from january 2009- 3 september 2010)
Following major subsequent earthquakes
4 september 2010- 22 february 2011
23 February - December 2011
Secondary outcome [1] 295536 0
The secondary aims of this study are to investigate changes over time in domains of functioning using the SDQ subscores; Emotional symptoms score, Conduct problems score, Hyperactivity scale, Peer problem score
Timepoint [1] 295536 0
The primary timepoints considered will be baseline (from january 2009- 3 september 2010)
Following major subsequent earthquakes
4 september 2010- 22 february 2011
23 February - December 2011
Secondary outcome [2] 295537 0
We will consider the impact of gender, ethnicity and socioeconomic status on behavioural and emotional wellbeing.
Timepoint [2] 295537 0
The primary timepoints considered will be baseline (from january 2009- 3 september 2010)
Following major subsequent earthquakes
4 september 2010- 22 february 2011
23 February - December 2011

Eligibility
Key inclusion criteria
B4 school check data from National B4 school check database for the Canterbury District Health Board region pertaining to the relevant data fields from January 2009 to December 2011 will be obtained.
Minimum age
4 Years
Maximum age
5 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
none

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12000
Accrual to date
Final
Recruitment outside Australia
Country [1] 4019 0
New Zealand
State/province [1] 4019 0

Funding & Sponsors
Funding source category [1] 284521 0
Hospital
Name [1] 284521 0
Canterbury District Health Board
Country [1] 284521 0
New Zealand
Primary sponsor type
Hospital
Name
Canterbury District Health Board
Address
Christchurch Hospital, Private Bag 4710, Christchurch, 8140, NZ
Country
New Zealand
Secondary sponsor category [1] 283451 0
University
Name [1] 283451 0
University of Otago, Christchurch
Address [1] 283451 0
Department of Psychological Medicine,
4 Oxford Terrace
Christchurch 8140
Country [1] 283451 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286335 0
Upper South B Regional Ethics Committee
Ethics committee address [1] 286335 0
Ethics committee country [1] 286335 0
New Zealand
Date submitted for ethics approval [1] 286335 0
Approval date [1] 286335 0
15/11/2011
Ethics approval number [1] 286335 0
URB/11/EXP/043

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

Contacts
Principal investigator
Name 33534 0
Address 33534 0
Country 33534 0
Phone 33534 0
Fax 33534 0
Email 33534 0
Contact person for public queries
Name 16781 0
Dr Janine Thomson
Address 16781 0
Paediatric Department, Christchurch Hospital
Private Bag 4710
Christchurch 8140
Country 16781 0
New Zealand
Phone 16781 0
+6433640640
Fax 16781 0
+6433640919
Email 16781 0
[email protected]
Contact person for scientific queries
Name 7709 0
Dr Janine Thomson
Address 7709 0
Paediatric Department, Christchurch Hospital
Private Bag 4710
Christchurch 8140
Country 7709 0
New Zealand
Phone 7709 0
+6433640640
Fax 7709 0
+6433640919
Email 7709 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.