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

NCT04254302 | Completed

• 1 other identifier: 2020-3429
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

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.

Conditions

Motor Disorders

Keywords

Tele-intervention; Motor delay; Child; Parental support

Outcome Measures

Primary Outcomes (1)

• Canadian Occupational Performance Measure (COPM)

  The COPM uses a structured interview to identify intervention goals. Ten-point numerical rating scales are then used to identify importance, actual performance and satisfaction with performance for each selected goal. Higher scores indicate higher importance, better performance and higher satisfaction with the child's performance. An increase of more than 2 points on the 10-point numerical rating scale is considered as a meaningful clinical difference and will be used as an indication of the attainment of the child's motor performance goal. The COPM does not require any physical or hands-on materials, which is consistent with an online trial.

  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 (5)

• Pediatric Evaluation of Disability Inventory - computer adaptive test (PEDI-CAT)

  Baseline and 1 year after the beggining of the intervention (pre- and post-intervention]

• Parental Knowledge and Skills Questionnaire (PKSQ)

  Baseline and 1 year after the beggining of the intervention (pre- and post-intervention]

• Parental Stress Scale (PSS)

  Baseline and 1 year after the beggining of the intervention (pre- and post-intervention]

• Six Dimension Short-Form Health Survey (SF-6D)

  Baseline and 1 year after the beggining of the intervention (pre- and post-intervention]

• Health-Related Quality of Life Utility Measure for Pre-School Children (HuPS)

  Baseline and 1 year after the beggining of the intervention (pre- and post-intervention]

Study Arms (2)

Control

NO INTERVENTION

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.

Experimental

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.

Other: WECARE web platform

Interventions

WECARE web platform 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.

Experimental

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Université de Sherbrooke: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Centre de recherche du CHUS

Sherbrooke, Quebec, J1E3A4, Canada

Location

MeSH Terms

Conditions

Motor Disorders; Psychomotor Disorders

Condition Hierarchy (Ancestors)

Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Chantal Camden, PhD

  Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinded data collection specialists will conduct pre-intervention COPM and PEDI-CAT interviews, as well as post-intervention PEDI-CAT interviews. All other measures are self-completed online. The researchers and data analyst will also be blinded to participant allocation. Participants will be made aware of their allocation group following goals selection.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 24, 2020
• First Posted: February 5, 2020
• Study Start: February 20, 2020
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: February 1, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)