Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000869279
Ethics application status
Approved
Date submitted
17/03/2009
Date registered
7/10/2009
Date last updated
11/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
In preschool children, does a universal movement and psychosocial development program increase the motor ability and social-emotional wellbeing compared with routine curriculum based programs?
Scientific title
In preschool children, does a universal movement and psychosocial development program increase the motor ability and social-emotional wellbeing compared with routine curriculum based programs?
Secondary ID [1] 295513 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
developmental coordination disorder 4489 0
poor social-emotional development 4490 0
Condition category
Condition code
Neurological 4770 4770 0 0
Other neurological disorders
Mental Health 4771 4771 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention includes:
4 modules on gross motor development - Body management -trunk and lower limb, locomotion, Object Control -throwing, catching and kicking, Body sequencing,
4 modules on fine motor development - body management -trunk and upper limb, fine motor planning, object control -manual skills, hand skills, and
1 module on social/emotional development -promoting laughter and happy feelings, idenification of positive and negative feelings, breathing and relaxation strategies.
The intervention is delivered by a classroom teacher over 10 weeks, with 15 minutes a day, 4 days a week for the gross motor modules; 15 minutes a day, 4 days a week for the fine motor modules, and 15 minutes a week for the social-emotional module.
Intervention code [1] 4240 0
Prevention
Comparator / control treatment
Normal pre-school curriculum which include the regular curricilum based acitivities that are implemented to address the health and education learning area targeting skills for physical activity, self-management skills and interpersonal skills.
Control group
Active

Outcomes
Primary outcome [1] 5633 0
Improved fine and grosss motor skills, namely an increase in fine and gross motor scores on the Bruininks-Oseretsky Test that is significantly greater than the control group.
Timepoint [1] 5633 0
Immediately after intervention and then 12 months later.
Secondary outcome [1] 241510 0
Improved social skills compared with the Control group, measured with the Social Skills Rating Scale (both parents and teachers).
Timepoint [1] 241510 0
Immediately after intervention and then 12 months later.

Eligibility
Key inclusion criteria
Preschool child attending government school in low SocioEconomic Status (SES) area
Minimum age
4 Years
Maximum age
7 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Diagnosed developmental and neurological disorders

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Schools are randomised. Pairs of equal size and socio-economic status (SES) were randomly allocated to control and intervention. Allocation was made once schools were deemed eligible to be included and control versus internvention decided by a coin toss -hence allocation was concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Coin toss for each pair
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
26/04/2009
Actual
26/04/2009
Date of last participant enrolment
Anticipated
Actual
30/04/2010
Date of last data collection
Anticipated
Actual
1/12/2011
Sample size
Target
380
Accrual to date
Final
540
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4679 0
Government body
Name [1] 4679 0
Healthway
Country [1] 4679 0
Australia
Primary sponsor type
University
Name
Curtin University of Technology
Address
GPO Box U1987
Perth 6845
WA
Country
Australia
Secondary sponsor category [1] 4225 0
None
Name [1] 4225 0
Address [1] 4225 0
Country [1] 4225 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6717 0
Curtin Human Research Ethics Committee
Ethics committee address [1] 6717 0
Ethics committee country [1] 6717 0
Australia
Date submitted for ethics approval [1] 6717 0
Approval date [1] 6717 0
10/02/2009
Ethics approval number [1] 6717 0
HR 02/2009

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

Contacts
Principal investigator
Name 29411 0
Address 29411 0
Country 29411 0
Phone 29411 0
Fax 29411 0
Email 29411 0
Contact person for public queries
Name 12658 0
Professor Jan Piek
Address 12658 0
School of Psychology
Curtin University
GPO Box U1987
Perth 6845
WA
Country 12658 0
Australia
Phone 12658 0
+61 8 9266 7990
Fax 12658 0
+61 8 92662464
Email 12658 0
[email protected]
Contact person for scientific queries
Name 3586 0
Professor Jan Piek
Address 3586 0
School of Psychology
Curtin University
GPO Box U1987
Perth 6845
WA
Country 3586 0
Australia
Phone 3586 0
+61 8 9266 7990
Fax 3586 0
+61 8 92662464
Email 3586 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
SourceTitleYear of PublicationDOI
Dimensions AIRationale, design and methods for a randomised and controlled trial to evaluate "Animal Fun" - a program designed to enhance physical and mental health in young children2010https://doi.org/10.1186/1471-2431-10-78
N.B. These documents automatically identified may not have been verified by the study sponsor.