A Teleintervention in Developmental Coordination Disorder (DCD)

May 2, 2018 updated by: Université de Sherbrooke

A Randomized Feasibility Trial Evaluating a Teleintervention for Families of Children With Developmental Coordination Disorder (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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
31

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Sherbrooke, Quebec, Canada, J1E 3A4
        • CR CHUS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

5 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Université de Sherbrooke

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Chantal Camden, CR CHUS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 6, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 12, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 27, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 5, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 8, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • usherbrooke

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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

Clinical Trials on Teleintervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings