Clinical trial NCT04254302: Using Telerehabilitation to Support Families of Children With Motor Difficulties Aged 3-8 Years Old
Official title: WECARE - Using Telerehabilitation to Support Families of Children With Motor Difficulties Aged 3-8 Years Old: A Patient-centred, Mixed-method Innovative Pragmatic Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Motor Disorders
Keywords: Tele-intervention
Motor delay
Child
Parental support
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2020-02-05
Enrollment: 118
Sex: ALL
Minimum age (years): 3
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The family will be the unit of randomization. A web-based randomization service will allocate participants to either usual care or the WECARE intervention (1:1). To ensure equal distribution of participants between arms, permutated blocks of variable (2:4:6) size will be generated. No stratification or minimization strategies will be used. Participants will be invited to set their motor-performance goals before allocation to avoid the influence of the allocation group on goals selection.
Primary purpose: TREATMENT

Brief summary: Background: Many children (about 1 child out of 20) have motor delays that are sometimes seen as "minor" and are not immediately explained by a specific diagnosis. These children are often underserved by existing health and rehabilitation services even though they are at risk of developing important negative outcomes in the long run. The most recent scientific evidence indicates that motor delays can be effectively addressed via early interventions supporting families and stimulating the child's development. Some researchers have proposed that such interventions could be efficiently and conveniently delivered online but no patient-centred, interactive online intervention has been formally trialed in Canada for children with motor delay and their families.

Objectives: The goal of this study is to determine whether an online intervention can support families of children with motor delay. This study will determine whether the online intervention can improve the child's motor skills and parental self-efficacy, decrease parental stress, as well as increase the quality of life of both the parent and child.

Description: The investigators will recruit 118 families of children with motor delay, 3 to 8 years of age, who are not yet receiving public rehabilitation services. These children will have been identified as at-risk of motor difficulties by their parents who will have completed a self-reported screening test for motor difficulties. Families will be randomly assigned to one of two groups: 1) control group (usual care) or 2) intervention group (access to the WECARE web platform, including one-on-one virtual meetings with health professionals, group and private discussions, verified resources). This study, conducted in Quebec, will be led by researchers, telerehabilitation experts, decision makers and patient advocates.

Relevance: This study will evaluate an innovative, convenient and accessible intervention providing assistance for an important yet underserved population of children and their families.

Detailed description: Detailed objectives:

The overarching goal of this patient-centred, mixed-methods, randomized, innovative pragmatic trial is to evaluate the effectiveness of the WECARE intervention for children aged 3-8 years with motor difficulties living in Quebec. The primary objective is to evaluate, in comparison to usual care management, the effectiveness of the WECARE program for improving the child's performance on parent-identified motor functioning targets. Secondary objective is to evaluate the effect of the intervention on children's functioning, parental self-efficacy, parental stress, as well as the quality of life of both the parent and child.

Detailed design: A patient-centred innovative pragmatic randomized controlled trial documenting real-world effectiveness of the WECARE intervention, offered to families of children with motor difficulties living in Quebec and receiving no public rehabilitation services. A primary respondent (i.e., parent or legal guardian) will be identified but the whole family will have access to the WECARE intervention.

This trial was designed according to the latest guidelines on pragmatic trials, using the gold-standard CONSORT guidelines, and the TElehealth in CHronic Disease (TECH) conceptual framework.

Eligibility criteria: Inclusion Criteria:

* Parent or legal guardian of a child aged 3-8 years old at risk of motor difficulties, as confirmed via the DCD-Questionnaire or Little DCD-Q
* Have at least one motor-related COPM objective at T0
* Live in Quebec.

Exclusion Criteria:

* Children receiving public rehabilitation services for their motor difficulties at time of enrolment (i.e. receiving either physiotherapy or occupational therapy services)
* Families whose parents could not provide a single motor performance related goal to inform the intervention.

Primary outcomes:
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: Structured interview and numerical rating scales : before intervention. Numerical rating scales only : every 3 months for 12 months (i.e 3 months, 6 months, 9 months and one year after the beggining of the intervention)).
Secondary outcomes:
measure: Pediatric Evaluation of Disability Inventory - computer adaptive test (PEDI-CAT)
timeFrame: Baseline and 1 year after the beggining of the intervention (pre- and post-intervention]
measure: Parental Knowledge and Skills Questionnaire (PKSQ)
timeFrame: Baseline and 1 year after the beggining of the intervention (pre- and post-intervention]
measure: Parental Stress Scale (PSS)
timeFrame: Baseline and 1 year after the beggining of the intervention (pre- and post-intervention]
measure: Six Dimension Short-Form Health Survey (SF-6D)
timeFrame: Baseline and 1 year after the beggining of the intervention (pre- and post-intervention]
measure: Health-Related Quality of Life Utility Measure for Pre-School Children (HuPS)
timeFrame: Baseline and 1 year after the beggining of the intervention (pre- and post-intervention]
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Centre de recherche du CHUS
state: Quebec
Study officials:
affiliation: Université de Sherbrooke
name: Chantal Camden, PhD
role: PRINCIPAL_INVESTIGATOR
References: