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DCD & ASD Imaging Intervention Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04119492
Recruitment Status : Recruiting
First Posted : October 8, 2019
Last Update Posted : October 8, 2019
Sponsor:
Collaborator:
Waterloo Foundation
Information provided by (Responsible Party):
Jill Zwicker, University of British Columbia

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.

Condition or disease Intervention/treatment Phase
Motor Skills Disorders Autism Spectrum Disorder Behavioral: CO-OP Treatment Group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomized to the CO-OP treatment group or the waitlist control group
Masking: Single (Outcomes Assessor)
Masking Description: The occupational therapist administering the pre- and post-assessments will be blinded to group assignment
Primary Purpose: Treatment
Official Title: Integrating Brain Imaging and Rehabilitation to Improve Outcomes for Children With Co-occurring DCD & ASD
Actual Study Start Date : February 20, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CO-OP Treatment Group
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
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.

No Intervention: Waitlist Control Group
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.



Primary Outcome Measures :
  1. Canadian Occupational Performance Measure (COPM) [ Time Frame: 12 weeks (before and after intervention) ]
    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.

  2. Diffusion Tensor Imaging on MRI [ Time Frame: 12 weeks (before and after intervention) ]
    Fractional anisotropy and diffusivity (mean, axial, and radial)


Secondary Outcome Measures :
  1. Performance Quality Rating Scale (PQRS) [ Time Frame: 12 weeks (before and after intervention) ]
    An occupational therapist not involved in the intervention and blinded to pre-test and post-test observes video-recordings of the child performing their three motor goals before and after intervention. The therapist rates the child's movement quality on a scale of 1 to 10, with '1' indicating that the skill is not done at all and '10' indicating that the skill is performed very well. A change of 3-points is considered clinically meaningful.

  2. Bruninks-Oseretsky Test of Motor Proficiency 2nd ed. (BOT-2) short form [ Time Frame: 12 weeks (before and after intervention) ]
    Standardized assessment of motor skills completed by a therapist not involved in the intervention.

  3. Resting-state connectivity on MRI [ Time Frame: 12 weeks (before and after intervention) ]
    Spatial independent components analysis of resting state networks

  4. Voxel-based morphometry [ Time Frame: 12 weeks (before and after intervention) ]
    white matter, cortical gray matter, deep gray matter, and total volumes for cerebrum and cerebellum



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   8 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04119492


Contacts
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Contact: Gisela G Gosse 604-875-2345 ext 5948 ggosse@cw.bc.ca
Contact: Janet Rigney 604-875-2345 ext 5948 jrigney@bcchr.ca

Locations
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Canada, British Columbia
University of British Columbia Recruiting
Vancouver, British Columbia, Canada, V6H 3V4
Contact: Gisela Gosse    604-875-2345 ext 5948    ggosse@cw.bc.ca   
Contact: Janet Rigney    604-875-2345 ext 5948    jrigney@bcchr.ca   
Sponsors and Collaborators
University of British Columbia
Waterloo Foundation
Investigators
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Principal Investigator: Jill G Zwicker, PhD University of British Columbia
Publications:
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.
Law M., Baptiste, S., Carswell, A., McColl, MA., Polatajko, H. & Pollock, N. Canadian Occupational Performance Measure Manual, 5th Edition. Canada. CAOT Publications ACE. 2014.
Henderson SE, Sugden DA, Barnett AL. Movement assessment battery for children - 2nd ed. Psychological Corporation London; 2007.
Wilson, B.N., Kaplan, B.J., Crawford, S.G., & Roberts, G. (2007). Developmental Coordination Questionnaire 2007 (DCDQ'07). Available at: http://www.dcdq.ca.
Conners CK. (2009). Conners3rd Edition (Conners 3). Toronto, ON: Multi-Health Systems.
Rutter M, Bailey A. Social communication questionnaire (SCQ). https://www.wpspublish.com/store/p/2954/scq-social-communication-questionnaire. Updated 2003.
Bruininks, R., & Bruininks, B. Bruininks-oseretsky test of motor proficiency. 2nd ed. Minneapolis, MN: NCS Pearson; 2005.

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Responsible Party: Jill Zwicker, Principle Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT04119492    
Other Study ID Numbers: H18-02759
First Posted: October 8, 2019    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jill Zwicker, University of British Columbia:
developmental coordination disorder
autism
brain imaging
MRI
rehabilitation
CO-OP
Additional relevant MeSH terms:
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Disease
Autism Spectrum Disorder
Motor Skills Disorders
Pathologic Processes
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders