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
|Condition or disease||Intervention/treatment||Phase|
|Motor Skills Disorders Autism Spectrum Disorder||Behavioral: CO-OP Treatment Group||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|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|
|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|
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.
- 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.
- Diffusion Tensor Imaging on MRI [ Time Frame: 12 weeks (before and after intervention) ]Fractional anisotropy and diffusivity (mean, axial, and radial)
- 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.
- 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.
- Resting-state connectivity on MRI [ Time Frame: 12 weeks (before and after intervention) ]Spatial independent components analysis of resting state networks
- 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
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
|Contact: Gisela G Gosse||604-875-2345 ext firstname.lastname@example.org|
|Contact: Janet Rigney||604-875-2345 ext email@example.com|
|Principal Investigator:||Jill G Zwicker, PhD||University of British Columbia|