Clinical trial NCT03141333: A Teleintervention in Developmental Coordination Disorder
Official title: A Randomized Feasibility Trial Evaluating a Teleintervention for Families of Children With Developmental Coordination Disorder (DCD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Developmental Coordination Disorder
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
First posted: 2017-05-05
Enrollment: 31
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Utilization of the teleintervention
timeFrame: 3 months (from day 1 to study completion)
Secondary outcomes:
measure: Recruitment and retention
timeFrame: Number of participants at baseline and at completion of the study (3 months later)
measure: Parents' sense of competencies
timeFrame: Collected at baseline and at completion of the study (3 months later)
measure: Parents' satisfaction with the intervention
timeFrame: At completion of the study (3 months following the begining of the teleintervention)
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: CR CHUS
state: Quebec
Study officials:
affiliation: CR CHUS
name: Chantal Camden
role: PRINCIPAL_INVESTIGATOR
References: