NCT04119492

Brief Summary

Developmental Coordination Disorder (DCD) is a neurodevelopmental disorder that affects a child's ability to learn motor skills, such as tying shoelaces, learning to print, or riding a bicycle (APA 2013). It often co-occurs with other conditions, such as Attention Deficit Hyperactivity Disorder (ADHD). Its high co-occurrence with Autism Spectrum Disorder (ASD) has only been permitted since 2013 so it is less well known. Recent neuroimaging studies have begun to unravel the neural underpinnings of each disorder; however, few brain imaging studies have included children with co-occurring DCD and ASD. The first aim of the proposed project is to understand brain structure and function in children with DCD+/-ASD. Despite high co-occurrence of DCD and ASD (Green 2009), motor impairment and functional problems are rarely the focus of therapy for children with ASD. Current best-practice for improving motor function is an approach called Cognitive Orientation to Occupational Performance (CO-OP). The second aim of this study is to examine effectiveness of this treatment approach for children with DCD+ASD and determine if there are brain changes and improvements in motor skills as a result of intervention. This novel project is the first to integrate brain imaging and motor-based rehabilitation in this population and builds on a current study examining brain changes in children with DCD (with and without co-occurring ADHD). Examining the neural basis of these motor difficulties in the presence or absence of co-occurring conditions will help to determine the neural correlates specific to DCD and whether the response to treatment differs in children with co-occurring conditions.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

February 20, 2019

Completed
8 months until next milestone

First Posted

Study publicly available on registry

October 8, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

October 12, 2020

Status Verified

October 1, 2020

Enrollment Period

2.4 years

First QC Date

December 19, 2018

Last Update Submit

October 8, 2020

Conditions

Keywords

developmental coordination disorderautismbrain imagingMRIrehabilitationCO-OP

Outcome Measures

Primary Outcomes (2)

  • Canadian Occupational Performance Measure (COPM)

    Children will rate performance and satisfaction of their three motor goals on a 10-point Likert scale, with higher scores indicating higher performance and satisfaction. A change of 2 points is considered clinically meaningful. The COPM is administered by an occupational therapist not involved in the intervention.

    12 weeks (before and after intervention)

  • Diffusion Tensor Imaging on MRI

    Fractional anisotropy and diffusivity (mean, axial, and radial)

    12 weeks (before and after intervention)

Secondary Outcomes (4)

  • Performance Quality Rating Scale (PQRS)

    12 weeks (before and after intervention)

  • Bruninks-Oseretsky Test of Motor Proficiency 2nd ed. (BOT-2) short form

    12 weeks (before and after intervention)

  • Resting-state connectivity on MRI

    12 weeks (before and after intervention)

  • Voxel-based morphometry

    12 weeks (before and after intervention)

Study Arms (2)

CO-OP Treatment Group

EXPERIMENTAL

Participants in the treatment group will receive occupational therapy once weekly for 10 weeks using the published protocol for the CO-OP approach.

Behavioral: CO-OP Treatment Group

Waitlist Control Group

NO INTERVENTION

Participants in the waitlist control group not receive CO-OP intervention during this time. They will receive their CO-OP intervention 12 weeks after their baseline assessment.

Interventions

Cognitive Orientation to Occupational Performance (CO-OP) is a cognitive approach to solving functional motor problems (Polatajko et al., 2001). Therapists teach children a global problem-solving strategy (Goal-Plan-Do-Check) as means to develop specific strategies for overcoming motor problems; the strategies are determined after a dynamic performance analysis by the therapist to determine where the "breakdown" is in performing the task. Occupational therapists trained in CO-OP will see children for one hour, once weekly for 10 weeks. Parents or caregivers will be encouraged to attend treat¬ment sessions so therapists can instruct them how to facilitate strategy use between treatment sessions. Children will select 3 functional motor goals to be addressed during treatment.

CO-OP Treatment Group

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children 8-12 years
  • Meet the diagnostic criteria for DCD and high-functioning ASD (without intellectual disability) as outlined in the Diagnostic and Statistical Manual - 5th edition
  • May have Attention Deficit Hyperactivity Disorder (ADHD) or learning disabilities

You may not qualify if:

  • Children with metallic objects in their body
  • Children with history of claustrophobia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of British Columbia

Vancouver, British Columbia, V6H 3V4, Canada

RECRUITING

Related Publications (29)

  • American Psychiatric Association, ed. Diagnostic and statistical manual of mental disorders - 5th edition (DSM-5). Washington, DC: American Psychiatric Association; 2013. https://doi.org/10.1176/appi.books.9780890425596.dsm01.

    BACKGROUND
  • Kirby A, Sugden D, Purcell C. Diagnosing developmental coordination disorders. Arch Dis Child. 2014 Mar;99(3):292-6. doi: 10.1136/archdischild-2012-303569. Epub 2013 Nov 19.

    PMID: 24255567BACKGROUND
  • Green D, Charman T, Pickles A, Chandler S, Loucas T, Simonoff E, Baird G. Impairment in movement skills of children with autistic spectrum disorders. Dev Med Child Neurol. 2009 Apr;51(4):311-6. doi: 10.1111/j.1469-8749.2008.03242.x. Epub 2008 Feb 3.

    PMID: 19207298BACKGROUND
  • Piek JP, Pitcher TM, Hay DA. Motor coordination and kinaesthesis in boys with attention deficit-hyperactivity disorder. Dev Med Child Neurol. 1999 Mar;41(3):159-65. doi: 10.1017/s0012162299000341.

    PMID: 10210248BACKGROUND
  • Dziuk MA, Gidley Larson JC, Apostu A, Mahone EM, Denckla MB, Mostofsky SH. Dyspraxia in autism: association with motor, social, and communicative deficits. Dev Med Child Neurol. 2007 Oct;49(10):734-9. doi: 10.1111/j.1469-8749.2007.00734.x.

    PMID: 17880641BACKGROUND
  • D'Mello AM, Moore DM, Crocetti D, Mostofsky SH, Stoodley CJ. Cerebellar gray matter differentiates children with early language delay in autism. Autism Res. 2016 Nov;9(11):1191-1204. doi: 10.1002/aur.1622. Epub 2016 Mar 22.

    PMID: 27868392BACKGROUND
  • Foster NE, Doyle-Thomas KA, Tryfon A, Ouimet T, Anagnostou E, Evans AC, Zwaigenbaum L, Lerch JP, Lewis JD, Hyde KL; NeuroDevNet ASD imaging group. Structural Gray Matter Differences During Childhood Development in Autism Spectrum Disorder: A Multimetric Approach. Pediatr Neurol. 2015 Oct;53(4):350-9. doi: 10.1016/j.pediatrneurol.2015.06.013. Epub 2015 Jun 25.

    PMID: 26231265BACKGROUND
  • Liu J, Yao L, Zhang W, Xiao Y, Liu L, Gao X, Shah C, Li S, Tao B, Gong Q, Lui S. Gray matter abnormalities in pediatric autism spectrum disorder: a meta-analysis with signed differential mapping. Eur Child Adolesc Psychiatry. 2017 Aug;26(8):933-945. doi: 10.1007/s00787-017-0964-4. Epub 2017 Feb 23.

    PMID: 28233073BACKGROUND
  • Zwicker JG, Missiuna C, Boyd LA. Neural correlates of developmental coordination disorder: a review of hypotheses. J Child Neurol. 2009 Oct;24(10):1273-81. doi: 10.1177/0883073809333537. Epub 2009 Aug 17.

    PMID: 19687388BACKGROUND
  • Zwicker JG, Missiuna C, Harris SR, Boyd LA. Brain activation associated with motor skill practice in children with developmental coordination disorder: an fMRI study. Int J Dev Neurosci. 2011 Apr;29(2):145-52. doi: 10.1016/j.ijdevneu.2010.12.002. Epub 2010 Dec 8.

    PMID: 21145385BACKGROUND
  • Langevin LM, Macmaster FP, Crawford S, Lebel C, Dewey D. Common white matter microstructure alterations in pediatric motor and attention disorders. J Pediatr. 2014 May;164(5):1157-1164.e1. doi: 10.1016/j.jpeds.2014.01.018. Epub 2014 Feb 25.

    PMID: 24576693BACKGROUND
  • Frazier TW, Hardan AY. A meta-analysis of the corpus callosum in autism. Biol Psychiatry. 2009 Nov 15;66(10):935-41. doi: 10.1016/j.biopsych.2009.07.022. Epub 2009 Sep 12.

    PMID: 19748080BACKGROUND
  • Caeyenberghs K, Taymans T, Wilson PH, Vanderstraeten G, Hosseini H, van Waelvelde H. Neural signature of developmental coordination disorder in the structural connectome independent of comorbid autism. Dev Sci. 2016 Jul;19(4):599-612. doi: 10.1111/desc.12424. Epub 2016 May 4.

    PMID: 27147441BACKGROUND
  • Cacola P, Miller HL, Ossom Williamson P. Behavioral comparisons in Autism Spectrum Disorder and Developmental Coordination Disorder: A systematic literature review. Res Autism Spectr Disord. 2017 Jun;38:6-18. doi: 10.1016/j.rasd.2017.03.004. Epub 2017 Mar 25.

    PMID: 29057009BACKGROUND
  • Smits-Engelsman BC, Blank R, van der Kaay AC, Mosterd-van der Meijs R, Vlugt-van den Brand E, Polatajko HJ, Wilson PH. Efficacy of interventions to improve motor performance in children with developmental coordination disorder: a combined systematic review and meta-analysis. Dev Med Child Neurol. 2013 Mar;55(3):229-37. doi: 10.1111/dmcn.12008. Epub 2012 Oct 29.

    PMID: 23106530BACKGROUND
  • Polatajko HJ, Mandich AD, Miller LT, Macnab JJ. Cognitive orientation to daily occupational performance (CO-OP): part II--the evidence. Phys Occup Ther Pediatr. 2001;20(2-3):83-106.

    PMID: 11345514BACKGROUND
  • Rodger S, Brandenburg J. Cognitive Orientation to (daily) Occupational Performance (CO-OP) with children with Asperger's syndrome who have motor-based occupational performance goals. Aust Occup Ther J. 2009 Feb;56(1):41-50. doi: 10.1111/j.1440-1630.2008.00739.x.

    PMID: 20854488BACKGROUND
  • Miller LT, Polatajko HJ, Missiuna C, Mandich AD, Macnab JJ. A pilot trial of a cognitive treatment for children with developmental coordination disorder. Hum Mov Sci. 2001 Mar;20(1-2):183-210. doi: 10.1016/s0167-9457(01)00034-3.

    PMID: 11471396BACKGROUND
  • Law M., Baptiste, S., Carswell, A., McColl, MA., Polatajko, H. & Pollock, N. Canadian Occupational Performance Measure Manual, 5th Edition. Canada. CAOT Publications ACE. 2014.

    BACKGROUND
  • Zwicker JG, Missiuna C, Harris SR, Boyd LA. Developmental coordination disorder: a pilot diffusion tensor imaging study. Pediatr Neurol. 2012 Mar;46(3):162-7. doi: 10.1016/j.pediatrneurol.2011.12.007.

    PMID: 22353291BACKGROUND
  • Henderson SE, Sugden DA, Barnett AL. Movement assessment battery for children - 2nd ed. Psychological Corporation London; 2007.

    BACKGROUND
  • Wilson, B.N., Kaplan, B.J., Crawford, S.G., & Roberts, G. (2007). Developmental Coordination Questionnaire 2007 (DCDQ'07). Available at: http://www.dcdq.ca.

    BACKGROUND
  • Conners CK. (2009). Conners3rd Edition (Conners 3). Toronto, ON: Multi-Health Systems.

    BACKGROUND
  • Rutter M, Bailey A. Social communication questionnaire (SCQ). https://www.wpspublish.com/store/p/2954/scq-social-communication-questionnaire. Updated 2003.

    BACKGROUND
  • Bruininks, R., & Bruininks, B. Bruininks-oseretsky test of motor proficiency. 2nd ed. Minneapolis, MN: NCS Pearson; 2005.

    BACKGROUND
  • Smith SM, Jenkinson M, Johansen-Berg H, Rueckert D, Nichols TE, Mackay CE, Watkins KE, Ciccarelli O, Cader MZ, Matthews PM, Behrens TE. Tract-based spatial statistics: voxelwise analysis of multi-subject diffusion data. Neuroimage. 2006 Jul 15;31(4):1487-505. doi: 10.1016/j.neuroimage.2006.02.024. Epub 2006 Apr 19.

    PMID: 16624579BACKGROUND
  • Ashburner J, Friston KJ. Voxel-based morphometry--the methods. Neuroimage. 2000 Jun;11(6 Pt 1):805-21. doi: 10.1006/nimg.2000.0582.

    PMID: 10860804BACKGROUND
  • Beckmann CF, DeLuca M, Devlin JT, Smith SM. Investigations into resting-state connectivity using independent component analysis. Philos Trans R Soc Lond B Biol Sci. 2005 May 29;360(1457):1001-13. doi: 10.1098/rstb.2005.1634.

    PMID: 16087444BACKGROUND
  • Kangarani-Farahani M, Zwicker JG. White matter changes with rehabilitation in children with Co-occurring autism spectrum disorder and developmental coordination disorder. Neuroimage Rep. 2025 Jun 16;5(3):100272. doi: 10.1016/j.ynirp.2025.100272. eCollection 2025 Sep.

MeSH Terms

Conditions

Motor Skills DisordersAutism Spectrum DisorderAutistic Disorder

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental DisordersChild Development Disorders, Pervasive

Study Officials

  • Jill G Zwicker, PhD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gisela G Gosse

CONTACT

Janet Rigney

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The occupational therapist administering the pre- and post-assessments will be blinded to group assignment
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomized to the CO-OP treatment group or the waitlist control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

December 19, 2018

First Posted

October 8, 2019

Study Start

February 20, 2019

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

October 12, 2020

Record last verified: 2020-10

Locations