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Trial registered on ANZCTR

Registration number

ACTRN12614000106639

Ethics application status

Approved

Date submitted

1/10/2013

Date registered

29/01/2014

Date last updated

29/01/2014

Type of registration

Retrospectively registered

Titles & IDs

Public title

Developmental coordination disorder – do personnel and environment impact on intervention outcomes for this condition?

Scientific title

Does the personnel delivering intervention and the environment of intervention impact on motor and psychosocial outcomes for children with Developmental Coordination Disorder (DCD)?

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Developmental Coordination Disorder

Condition category

Condition code

Neurological

Other neurological disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

All participants received a group based task specific motor intervention in which they attended a one hour session once a week for 13 weeks. The one hour seession included gross motor and fine motor activities which were developmentally appropriate for 5- 8 year olds. The basis of task specific intervention is practising the task itself under different conditions rather than focussing on impairments which contribute to difficulties with task. Each group had a maximum of 6 participants and had a staff to participant ratio of 1:3. There were three intervention modes which were compared. One mode was run by a physiotherapist in a health clinic setting, a second mode was run by a physiotherapist in a school setting and a third mode was run by a school assistant in a school setting.

Intervention code [1]

Treatment: Other

Comparator / control treatment

Evidence based intervention delivered by physiotherapist in clinic setting which accounts for the mode of intervention provided by a physiotherapist in a health clinic setting. This group of participants received the group based task specific intervention once a week for an hour over 13 weeks in groups of 4-6 with a staff to participant ratio of 1:3.

Control group

Active

Outcomes

Primary outcome [1]

Motor Skill Competence assessed using Movement Assessment Battery for Children (MABC) and Test of Gross Motor Development (TGMD-2)

Timepoint [1]

Immediately post intervention

Secondary outcome [1]

Perceived self competence and social acceptance assessed using the Pictorial Scale of Percevied Self Competence and Social Acceptance.

Timepoint [1]

Immediately post- intervention

Eligibility

Key inclusion criteria

Children aged 5- 8 years meeting DSM-IV-TR criteria for Developmental Coordination Disorder

Minimum age

5 Years

Maximum age

9 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Intellectual Disability and Autism

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Children screened in select SA public schools for DCD using standardised questionnaire DCD-Q. If consented children deemed at risk of DCD complete further testing using Movement Assessment Battery for Children (MABC) to confirm motor impairment and parents complete questionniare to screen for exclusion criteria. Children in each school identified with DCD offered intervention. Type of intervention determined by cluster randomisation of schools to particular mode of intervention. Assessor was blind to type of intervention each school was allocated.Randomisation of schools was generated from a computer random numbers table and allocated by a third party independent of the study who was "off site".

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Schools randomised computer generated to either control or 2 other intervention modes

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people assessing the outcomes

Intervention assignment

Parallel

Other design features

Two settings and two types of personnel were compared for intervention delivery. Health centre based therapy by physiotherapist known to be effective was compared to school based intervention by physiotherapist to compare environment. Personnel were compared by adding a third group providing intervention in schools run by schools assistants.

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Mixed model analysis of motor and psychosocial outcomes, significance level p<0.05
Power Calculation : Power calculations determined 78 participants with 26 in each mode of delivery required for 80% power with an alpha level of 0.05 based on a 6.5 point change in MABC score. While 78 were required 93 were recruited providing a larger sample.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

14/07/2006

Actual

14/07/2006

Date of last participant enrolment

Anticipated

30/01/2007

Actual

5/03/2007

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment postcode(s) [1]

5046 - Warradale

Recruitment postcode(s) [2]

5045 - Glenelg

Recruitment postcode(s) [3]

5048 - Brighton

Recruitment postcode(s) [4]

5159 - Happy Valley

Recruitment postcode(s) [5]

5163 - Hackham

Recruitment postcode(s) [6]

5166 - O'sullivan Beach

Recruitment postcode(s) [7]

5168 - Noarlunga Centre

Recruitment postcode(s) [8]

5038 - Plympton

Recruitment postcode(s) [9]

5035 - Black Forest

Recruitment postcode(s) [10]

5039 - Edwardstown

Recruitment postcode(s) [11]

5043 - Ascot Park

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of South Australia

Address [1]

GPO Box 2471
Adelaide SA 5001

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

Volunteer Service for Flinders Medical Centre Inc

Address [2]

Flinders Drive
Bedford Park SA 5062

Country [2]

Australia

Primary sponsor type

University

Name

University of South Australia

Address

GPO Box 2471
Adelaide SA 5001

Country

Australia

Secondary sponsor category [1]

Government body

Name [1]

Department of Education and Child Development

Address [1]

GPO Box 1152
ADELAIDE SA 5001

Country [1]

Australia

Other collaborator category [1]

Hospital

Name [1]

Southern Adelaide Health Service

Address [1]

Flinders Drive
Bedford Park SA 5062

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of South Australia Human Research Ethics Committee

Ethics committee address [1]

PO Box 2471
Adelaide SA 5001

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

07/07/2006

Ethics approval number [1]

P137/06

Ethics committee name [2]

Flinders Medical Centre Research Ethics Committee

Ethics committee address [2]

Flinders Drive
Bedford Park SA 5062

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

05/07/2006

Ethics approval number [2]

FWA A00001785

Ethics committee name [3]

Department of Education and Children's Services Ethics Committee

Ethics committee address [3]

Postal address
GPO Box 1152 
ADELAIDE SA 5001

Ethics committee country [3]

Australia

Date submitted for ethics approval [3]

Approval date [3]

11/07/2006

Ethics approval number [3]

CS/06/0110-2.1

Summary

Brief summary

Intervention for Developmental Coordination Disorder (DCD) has been shown to be better than no intervention, however there is scarce information on the delivery of all types of intervention.  This study compares different personnel and environments in service delivery.  Ninety-three children from 13 South Australian schools, aged five to eight years (at time of recruitment) were recruited to participate in this RCT.  Participants received a group intervention running for 13 weeks, working on fine and gross motor skills.  Schools were randomised using cluster randomisation to receive one of three modes of delivery.  Group one schools received the program at school run by a school assistant, group two received the program in school run by a physiotherapist and group three received the intervention in a health clinic run by a physiotherapist.  Group three was considered the control group for delivery as the literature concludes group programs run by health professionals in a health setting have success in treating children with DCD.  Participants were assessed pre and post-intervention, and six months after the program completion.  The Movement Assessment Battery for Children (MABC), Test of Gross Motor Development – Second Edition (TGMD-2), Pictorial Scale of Perceived Competence and Social Acceptance for Young Children (PSPCSA) and the School Function Assessment (SFA) were used to assess participants, while parent and child questionnaires were used to gain information on more practical aspects of service delivery.

Trial website

Trial related presentations / publications

Ward EJ, Hillier S and Raynor A (2009): Developmental coordination disorder – do environment and personnel impact on intervention outcomes for this condition?, June 26th 2009, (Conference Abstract) DCD-VIII Conference, Developmental Coordination Disorder, Baltimore, June 2009, 

Ward EJ, Hillier S and Raynor A (2009): Developmental coordination disorder – do environment and personnel impact on intervention outcomes for this condition?, October 1st 2009, (Conference Abstract) APA Conference (National Paediatric Group), Australian Physiotherapy Association, Sydney, October 2009

Ward EJ, Hillier S and Raynor A (2007): Do environment and personnel influence the effectiveness of group motor coordination programmes for children with DCD: an RCT, October 4th 2007 (Conference Abstract), Australian Physiotherapy Association Conference Week 2007, Cairns, October 2007

Ward EJ, Hillier S, Raynor A and Kay D (2007): Health service delivery strategies for children with DCD, (Conference Abstract) DCD-VII Conference, Developmental Coordination Disorder, Melbourne, February 2007, p.92

Public notes

Contacts

Principal investigator

Name

Dr Emily Ward

Address

University of South Australia
School of Health Sciences
PO Box 2471
Adelaide 5001

Country

Australia

Phone

+61 8 83021839

Fax

Emily.Ward@unisa.edu.au

Contact person for public queries

Name

Emily Ward

Address

University of South Australia
School of Health Sciences
PO Box 2471
Adelaide 5001

Country

Australia

Phone

+61 8 83021839

Fax

Emily.Ward@unisa.edu.au

Contact person for scientific queries

Name

Emily Ward

Address

University of South Australia
School of Health Sciences
PO Box 2471
Adelaide 5001

Country

Australia

Phone

+61 8 83021839

Fax

Emily.Ward@unisa.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

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