Autism Spectrum Disorder Clinical Trial
Official title:
Integrating Brain Imaging and Rehabilitation to Improve Outcomes for Children With Co-occurring DCD & ASD
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | June 30, 2021 |
Est. primary completion date | June 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 8 Years to 12 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Canada | University of British Columbia | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
University of British Columbia | Waterloo Foundation |
Canada,
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.
Ashburner J, Friston KJ. Voxel-based morphometry--the methods. Neuroimage. 2000 Jun;11(6 Pt 1):805-21. Review. — View Citation
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. — View Citation
Bruininks, R., & Bruininks, B. Bruininks-oseretsky test of motor proficiency. 2nd ed. Minneapolis, MN: NCS Pearson; 2005.
Caçola P, Miller HL, Williamson PO. 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. — View Citation
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. — View Citation
Conners CK. (2009). Conners3rd Edition (Conners 3). Toronto, ON: Multi-Health Systems.
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Henderson SE, Sugden DA, Barnett AL. Movement assessment battery for children - 2nd ed. Psychological Corporation London; 2007.
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. Review. — View Citation
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. — View Citation
Law M., Baptiste, S., Carswell, A., McColl, MA., Polatajko, H. & Pollock, N. Canadian Occupational Performance Measure Manual, 5th Edition. Canada. CAOT Publications ACE. 2014.
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. — View Citation
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. — View Citation
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. — View Citation
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. Review. — View Citation
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. — View Citation
Rutter M, Bailey A. Social communication questionnaire (SCQ). https://www.wpspublish.com/store/p/2954/scq-social-communication-questionnaire. Updated 2003.
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. Epub 2006 Apr 19. — View Citation
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. Review. — View Citation
Wilson, B.N., Kaplan, B.J., Crawford, S.G., & Roberts, G. (2007). Developmental Coordination Questionnaire 2007 (DCDQ'07). Available at: http://www.dcdq.ca.
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. Review. — View Citation
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. — View Citation
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. — View Citation
* Note: There are 28 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | |
Primary | Diffusion Tensor Imaging on MRI | Fractional anisotropy and diffusivity (mean, axial, and radial) | 12 weeks (before and after intervention) | |
Secondary | Performance Quality Rating Scale (PQRS) | 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. | 12 weeks (before and after intervention) | |
Secondary | Bruninks-Oseretsky Test of Motor Proficiency 2nd ed. (BOT-2) short form | Standardized assessment of motor skills completed by a therapist not involved in the intervention. | 12 weeks (before and after intervention) | |
Secondary | Resting-state connectivity on MRI | Spatial independent components analysis of resting state networks | 12 weeks (before and after intervention) | |
Secondary | Voxel-based morphometry | white matter, cortical gray matter, deep gray matter, and total volumes for cerebrum and cerebellum | 12 weeks (before and after intervention) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05207956 -
App for Strengthening Services In Specialized Therapeutic Support
|
N/A | |
Completed |
NCT03286621 -
Development of Eye-tracking Based Markers for Autism in Young Children
|
||
Completed |
NCT02608333 -
Efficiency of Early Intervention for Autism Spectrum Disorder
|
N/A | |
Recruiting |
NCT05935722 -
Evaluation of a Home-based Parenting Support Program: Parenting Young Children
|
N/A | |
Active, not recruiting |
NCT06259539 -
A YouTube Curriculum for Children With Autism and Obesity
|
N/A | |
Active, not recruiting |
NCT06303791 -
Digital-based Psychosocial Intervention for Parents of Children With Neurodevelopmental Disorders
|
N/A | |
Enrolling by invitation |
NCT05017779 -
A Hybrid Effectiveness-implementation Trial of a High School-based Executive Function Treatment for Autistic Youth
|
N/A | |
Completed |
NCT04772898 -
Effectiveness of a 6-week Hippotherapy Program in Children With Autism Spectrum Disorder
|
N/A | |
Recruiting |
NCT04987541 -
The Therapeutic Effect of TBS Stimulation on Emotion Regulation in Autism Spectrum Disorder
|
N/A | |
Completed |
NCT04308915 -
Mobile-based Games for Cognitive Training in Children With Neurodevelopmental Disorders
|
N/A | |
Completed |
NCT06038435 -
The Effect of Cognitive Orientation Approach on Daily Occupational Performance With Autism Spectrum Disorder
|
N/A | |
Terminated |
NCT04049981 -
Investigation of Mechanisms of Action in Superpower Glass
|
Phase 1/Phase 2 | |
Completed |
NCT03693313 -
The Effect of CrossFit Kids on Social Skills in Children With Autism Spectrum Disorder (CrossFit KAMP)
|
N/A | |
Recruiting |
NCT04107064 -
Achieving Steady Work Among Adults With Autism Through Specialized Employment Program
|
N/A | |
Recruiting |
NCT03812068 -
Parent-mediated Developmental Behavioral Intervention
|
N/A | |
Completed |
NCT03206996 -
Exposure Therapy for Auditory Sensitivity in Autism
|
N/A | |
Completed |
NCT02299700 -
Study to Evaluate the Janssen Autism Knowledge Engine in Children and Adults With Autism Spectrum Disorder
|
N/A | |
Completed |
NCT03422016 -
Electroretinogram in Autistic Spectrum Disorders
|
||
Active, not recruiting |
NCT03548779 -
North Carolina Genomic Evaluation by Next-generation Exome Sequencing, 2
|
N/A | |
Recruiting |
NCT05114538 -
Improving the Part C Early Intervention Service Delivery System for Children With ASD
|
N/A |