A Teleintervention in Developmental Coordination Disorder (DCD)
Primary Purpose
Developmental Coordination Disorder
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Teleintervention
Sponsored by
About this trial
This is an interventional treatment trial for Developmental Coordination Disorder
Eligibility Criteria
Inclusion Criteria:
- A DCD medical diagnostic (or DCD medical hypothesis)
- Must be at or under the 16e percentile for the global score at the Movement Assessment Battery for Children-2 (MABC-2) or be at or under the 5e for one of the 3 subscale of the MABC-2.
Exclusion Criteria:
- Do not have other neurodevelopmental diagnoses, with the exception of Attention Deficit Hyperactivity Disorder (ADHD)
- Do not receive rehabilitation services for DCD in the public health care system
Sites / Locations
- CR CHUS
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Teleintervention
No intervention
Arm Description
Participants of this group will have access to the following sections in the web plate-form: information, forum, chat and live online consultation. The teleintervention consists of having access to the forum, chat and live online consultation sections of the web plate-form.
Participants of this group will have access to the following section of the web plate-form: information, which is consistent with the standard of care for many families of children with DCD, who only have access to online information but do not have access to any type of intervention.
Outcomes
Primary Outcome Measures
Utilization of the teleintervention
Time spent on the web plate-form (calculated in minutes, time spent on the plate-form during the 3 months teleintervention)
Secondary Outcome Measures
Recruitment and retention
Number of participants recruited and retention rate
Parents' sense of competencies
Parenting Sense of Competence Scale
Parents' satisfaction with the intervention
Qualitative interviews
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03141333
Brief Title
A Teleintervention in Developmental Coordination Disorder
Acronym
DCD
Official Title
A Randomized Feasibility Trial Evaluating a Teleintervention for Families of Children With Developmental Coordination Disorder (DCD)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
February 6, 2017 (Actual)
Primary Completion Date
May 12, 2017 (Actual)
Study Completion Date
July 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Université de Sherbrooke
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The principal study goals are to determine if a randomized control trial would be feasible, particularly with regards to i) recruitment and retention of parents of children having a diagnosis or a suspicion of diagnosis of DCD, and ii) parents' utilization of the teleintervention. The study will also examine quantitatively and qualitatively families' acceptability of- and satisfaction with the teleintervention.
Detailed Description
Developmental coordination disorder (DCD) is a neurodevelopmental disorder characterised by difficulties in planning and execution of motor coordination activities like dressing, sports and writing. Increasing parents' capacity to manage their children's needs is part of the recommended DCD best practices, as soon as children are suspected to have DCD or early following diagnosis. Parents' capacity could be increased through simple, community-based interventions using a consultative approach. Using the Internet could be an interesting avenue to develop public community-based services and build parents' capacity to manage their child with DCD. The feasibility of recruiting and using the Internet to build parents' capacity is however unknown, since no such study have been conducted.
This randomized feasibility trail will experiment a teleintervention, characterized by a virtual interaction between a health professional and a user by Internet, for children with DCD. The principal study goals are to determine if a randomized control trial would be feasible, particularly with regards to i) recruitment and retention of parents of children having a diagnosis or a suspicion of diagnosis of DCD, and ii) parents' utilization of the teleintervention. The study will also examine quantitatively and qualitatively families' acceptability of- and satisfaction with the teleintervention. As part of the evaluation of acceptability, the impact of the teleintervention on parental competencies will be explored. At the end of the 3-months randomized feasibility trial, the influence of the number of participants on the utilization of the teleintervention will be explored by providing access to the teleintervention to all participants (control and intervention).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Developmental Coordination Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Teleintervention
Arm Type
Experimental
Arm Description
Participants of this group will have access to the following sections in the web plate-form: information, forum, chat and live online consultation. The teleintervention consists of having access to the forum, chat and live online consultation sections of the web plate-form.
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
Participants of this group will have access to the following section of the web plate-form: information, which is consistent with the standard of care for many families of children with DCD, who only have access to online information but do not have access to any type of intervention.
Intervention Type
Behavioral
Intervention Name(s)
Teleintervention
Intervention Description
Participants of this group will have access to the following sections in the web plate-form: information, forum, chat and live online consultation. The teleintervention consists of having access to the forum, chat and live online consultation sections of the web plate-form.
Primary Outcome Measure Information:
Title
Utilization of the teleintervention
Description
Time spent on the web plate-form (calculated in minutes, time spent on the plate-form during the 3 months teleintervention)
Time Frame
3 months (from day 1 to study completion)
Secondary Outcome Measure Information:
Title
Recruitment and retention
Description
Number of participants recruited and retention rate
Time Frame
Number of participants at baseline and at completion of the study (3 months later)
Title
Parents' sense of competencies
Description
Parenting Sense of Competence Scale
Time Frame
Collected at baseline and at completion of the study (3 months later)
Title
Parents' satisfaction with the intervention
Description
Qualitative interviews
Time Frame
At completion of the study (3 months following the begining of the teleintervention)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
A DCD medical diagnostic (or DCD medical hypothesis)
Must be at or under the 16e percentile for the global score at the Movement Assessment Battery for Children-2 (MABC-2) or be at or under the 5e for one of the 3 subscale of the MABC-2.
Exclusion Criteria:
Do not have other neurodevelopmental diagnoses, with the exception of Attention Deficit Hyperactivity Disorder (ADHD)
Do not receive rehabilitation services for DCD in the public health care system
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chantal Camden
Organizational Affiliation
CR CHUS
Official's Role
Principal Investigator
Facility Information:
Facility Name
CR CHUS
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1E 3A4
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
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A Teleintervention in Developmental Coordination Disorder
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