- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03141333
A Teleintervention in Developmental Coordination Disorder (DCD)
A Randomized Feasibility Trial Evaluating a Teleintervention for Families of Children With Developmental Coordination Disorder (DCD)
Study Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Quebec
-
Sherbrooke, Quebec, Canada, J1E 3A4
- CR CHUS
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Teleintervention
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 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.
|
No Intervention: No intervention
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Utilization of the teleintervention
Time Frame: 3 months (from day 1 to study completion)
|
Time spent on the web plate-form (calculated in minutes, time spent on the plate-form during the 3 months teleintervention)
|
3 months (from day 1 to study completion)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recruitment and retention
Time Frame: Number of participants at baseline and at completion of the study (3 months later)
|
Number of participants recruited and retention rate
|
Number of participants at baseline and at completion of the study (3 months later)
|
Parents' sense of competencies
Time Frame: Collected at baseline and at completion of the study (3 months later)
|
Parenting Sense of Competence Scale
|
Collected at baseline and at completion of the study (3 months later)
|
Parents' satisfaction with the intervention
Time Frame: At completion of the study (3 months following the begining of the teleintervention)
|
Qualitative interviews
|
At completion of the study (3 months following the begining of the teleintervention)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Chantal Camden, CR CHUS
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- usherbrooke
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Developmental Coordination Disorder
-
Virginia Commonwealth UniversityCompletedMotor Coordination or Function; Developmental DisorderUnited States
-
Duquesne UniversityPennsylvania Department of HealthCompletedMotor Coordination or Function; Developmental DisorderUnited States
-
University Hospital, MontpellierNot yet recruitingDevelopmental Coordination DisorderFrance
-
Hospices Civils de LyonRecruitingNeurodevelopmental Disorders | Motor Skills DisordersFrance
-
University GhentCompletedDevelopmental Coordination DisorderBelgium
-
University of CalgaryCompleted
-
Clalit Health ServicesTimocco LtdUnknownDevelopmental Coordination Disorder
-
University GhentRecruiting
-
The University of Hong KongNot yet recruitingDevelopmental Coordination DisorderHong Kong
-
University GhentCompletedDevelopmental Coordination DisorderBelgium
Clinical Trials on Teleintervention
-
Hebrew University of JerusalemNot yet recruitingNeurodevelopmental Disorders | Telerehabilitation