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A Teleintervention in Developmental Coordination Disorder (DCD)

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ClinicalTrials.gov Identifier: NCT03141333
Recruitment Status : Completed
First Posted : May 5, 2017
Last Update Posted : May 8, 2018
Sponsor:
Information provided by (Responsible Party):
Université de Sherbrooke

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.

Condition or disease Intervention/treatment Phase
Developmental Coordination Disorder Behavioral: Teleintervention Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Feasibility Trial Evaluating a Teleintervention for Families of Children With Developmental Coordination Disorder (DCD)
Actual Study Start Date : February 6, 2017
Actual Primary Completion Date : May 12, 2017
Actual Study Completion Date : July 30, 2017

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.
Behavioral: 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.

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.



Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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

  2. Parents' sense of competencies [ Time Frame: Collected at baseline and at completion of the study (3 months later) ]
    Parenting Sense of Competence Scale

  3. Parents' satisfaction with the intervention [ Time Frame: At completion of the study (3 months following the begining of the teleintervention) ]
    Qualitative interviews



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT03141333


Locations
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Canada, Quebec
CR CHUS
Sherbrooke, Quebec, Canada, J1E 3A4
Sponsors and Collaborators
Université de Sherbrooke
Investigators
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Principal Investigator: Chantal Camden CR CHUS

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Responsible Party: Université de Sherbrooke
ClinicalTrials.gov Identifier: NCT03141333     History of Changes
Other Study ID Numbers: usherbrooke
First Posted: May 5, 2017    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Disease
Ataxia
Motor Skills Disorders
Pathologic Processes
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurodevelopmental Disorders
Mental Disorders