Using Telerehabilitation to Support Families of Children With Motor Difficulties Aged 3-8 Years Old

NCT ID: NCT04254302

Last Updated: 2022-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 118 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-20
• Study Completion Date: 2021-10-01

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.

Conditions

Motor Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control

Participants randomized into the control arm will receive usual care as per the service delivery models and pathways planned in their region. As a pragmatic trial, no attempt will be made to standardize practices which may vary across professionals. Usual practices may be categorised as either reference to online websites deemed appropriate by their healthcare professional, general recommendations, referral for services, or none of the above.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Experimental

WECARE intervention include: 1) 30-minute appointments with an occupational therapist or a physiotherapist, as part of a multidisciplinary team, to problem-solve the child's motor performance issues, provide recommendations to stimulate the child's motor development, and intervene online directly with the child, if needed; offered bimonthly during the first three months, then on a patient-identified needs-basis. 2) A chat function where participants can privately contact the therapist; flexible access as per participant needs. 3) A forum open to all intervention group participants where they can communicate with each other or with the therapist, who will also act as a forum moderator; flexible access as per participant needs. 4) Access to static online information via relevant websites and resources on child development; flexible access based on participant needs.

Group Type: EXPERIMENTAL

WECARE web platform

Intervention Type: OTHER

The WECARE intervention allows families of children with motor difficulties to access rehabilitation therapists. The primary therapist will be an occupational therapist or a physiotherapist who will have one day a week to deliver the intervention. The therapist will act as case manager to connect families with community-based services available in their region and work, according to a transdisciplinary model, with an interdisciplinary team on a needs-based basis. Patient engagement with the therapists and in the WECARE intervention will be ensured by the collaborative coaching approach used by therapists to attain meaningful motor outcomes, as selected by the primary respondent.

Interventions

WECARE web platform

The WECARE intervention allows families of children with motor difficulties to access rehabilitation therapists. The primary therapist will be an occupational therapist or a physiotherapist who will have one day a week to deliver the intervention. The therapist will act as case manager to connect families with community-based services available in their region and work, according to a transdisciplinary model, with an interdisciplinary team on a needs-based basis. Patient engagement with the therapists and in the WECARE intervention will be ensured by the collaborative coaching approach used by therapists to attain meaningful motor outcomes, as selected by the primary respondent.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Université de Sherbrooke

OTHER

Sponsor Role: lead

Responsible Party

Chantal Camden

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chantal Camden, PhD

Role: PRINCIPAL_INVESTIGATOR

Université de Sherbrooke

Locations

Centre de recherche du CHUS

Sherbrooke, Quebec, Canada

Countries

Canada

Other Identifiers

2020-3429

Identifier Type: -

Identifier Source: org_study_id