NCT03141333

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 6, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 5, 2017

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 12, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2017

Completed
Last Updated

May 8, 2018

Status Verified

January 1, 2017

Enrollment Period

3 months

First QC Date

April 27, 2017

Last Update Submit

May 2, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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)

    3 months (from day 1 to study completion)

Secondary Outcomes (3)

  • Recruitment and retention

    Number of participants at baseline and at completion of the study (3 months later)

  • Parents' sense of competencies

    Collected at baseline and at completion of the study (3 months later)

  • Parents' satisfaction with the intervention

    At completion of the study (3 months following the begining of the teleintervention)

Study Arms (2)

Teleintervention

EXPERIMENTAL

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

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.

Interventions

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.

Teleintervention

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CR CHUS

Sherbrooke, Quebec, J1E 3A4, Canada

Location

MeSH Terms

Conditions

Motor Skills Disorders

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental Disorders

Study Officials

  • Chantal Camden

    CR CHUS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2017

First Posted

May 5, 2017

Study Start

February 6, 2017

Primary Completion

May 12, 2017

Study Completion

July 30, 2017

Last Updated

May 8, 2018

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations