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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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

developmental coordination disorder

poor social-emotional development

Condition category

Condition code

Neurological

Other neurological disorders

Mental Health

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]

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]

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]

Immediately after intervention and then 12 months later.

Secondary outcome [1]

Improved social skills compared with the Control group, measured with the Social Skills Rating Scale (both parents and teachers).

Timepoint [1]

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]

Government body

Name [1]

Healthway

Address [1]

Level 3, 46 Parliament Place
Perth
WA 6000

Country [1]

Australia

Primary sponsor type

University

Name

Curtin University of Technology

Address

GPO Box U1987
Perth 6845
WA

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Curtin Human Research Ethics Committee

Ethics committee address [1]

Curtin University
PO Box U1987
PERTH
Western Australia 6845

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

10/02/2009

Ethics approval number [1]

HR 02/2009

Summary

Brief summary

We will provide a motor and psychosocial intervention to preschool in 6 schools in WA and compare their performance with 6 control schools.

Trial website

Trial related presentations / publications

Publications 
     Piek, J.P., Straker, L.M., Jensen, L., Dender, A., Barrett, N.C., McLaren, S. Roberts, C,  Reid, C.,   Rooney, R., Packer, T., Bradbury, G. & Elsley, S. (2010). Rationale, design and methods for a randomised and controlled trial to evaluate “Animal Fun” - a program designed to enhance physical and mental health in young  children. BMC Pediatrics, 10, 78. 
     Wilson, A., Piek, J.P., & Kane, R. (2013). An investigation of the relationship between motor ability and internalising symptoms in pre-primary children: The mediating role of social skills. Infant and Child Development, 22, 151-164.  DOI: 10.1002/icd.1773
     Piek, J.P., McLaren, S., Kane, R., Jensen, L., Dender, A., Roberts, C., Rooney, R., Packer, T.  & Straker, L. (2013)  Does the Animal Fun program improve motor performance in children aged 4-6 years? Human Movement Science, 32, 1086-1096. http://dx.doi.org/10.1016/j.humov.2012.08.004
     Piek, J.P., Kane, R., Rigoli, D., McLaren, S., Roberts, C.M., Rooney, R., Jensen, L., Dender, A., Packer, T., & Straker, L. (2015). Does the Animal Fun program improve social-emotional and behavioural outcomes in children aged 4-6 year? Human Movement Science, 43, 155-163.  http://dx.doi.org/10.1016/j.humov.2015.08.004  
     Mancini, V., Rigoli, D., Roberts, L., Heritage, B. & Piek, J.P. (in press). The Relationship between motor skills and psychosocial factors in young children: a test of the elaborated environmental stress hypothesis.  British Journal of Educational Psychology
     Jorge A. De Oliveira, Daniela Rigoli, Robert Kane, Sue McLaren , Juliana B. Goulardins, Leon M Straker , Alma Dender, Rosanna Rooney & Jan P. Piek .(in press) Does ‘Animal Fun’ improve aiming and catching, and balance skills in young children? Research in Developmental Disorders

Invited Presentations
Jan Piek: Animal Fun: A physical activity and mental health program targeting pre-primary children. Healthway Launch of 2013 Funding Round. Perth, WA, 23rd November, 2012
Jan Piek: Developmental Coordination Disorder: Comorbidity, Self-Concept and Social-Emotional Development. School of Psychology, Australian Catholic University, Melbourne, 20th September, 2012. 
Jan Piek: Animal Fun: A movement program promoting physical and mental health. Centre for Research into Disability and Society, Curtin Uni, 16th March, 2011. 

Other presentations:
Piek, J., McLaren, S., Kane, R., Jensen, L., Dender, A., Straker, L., Roberts, C., Rooney, R. & Packer, T. (2011). Does the Animal Fun program improve motor ability in Children aged 4-6 years? 10th Motor Control & Human Skill Conference, Mandurah, WA. 29th Nov-2nd Dec.

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Professor Jan Piek

Address

School of Psychology
Curtin University
GPO Box U1987
Perth 6845
WA

Country

Australia

Phone

+61 8 9266 7990

Fax

+61 8 92662464

j.piek@curtin.edu.au

Contact person for scientific queries

Name

Professor Jan Piek

Address

School of Psychology
Curtin University
GPO Box U1987
Perth 6845
WA

Country

Australia

Phone

+61 8 9266 7990

Fax

+61 8 92662464

j.piek@curtin.edu.au

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

Source	Title	Year of Publication	DOI
Dimensions AI	Rationale, design and methods for a randomised and controlled trial to evaluate "Animal Fun" - a program designed to enhance physical and mental health in young children	2010	https://doi.org/10.1186/1471-2431-10-78

N.B. These documents automatically identified may not have been verified by the study sponsor.

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