Move&Connect: A Program for Youth With Concussion and Their Caregivers.
NCT ID: NCT05631301
Last Updated: 2025-10-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
150 participants
INTERVENTIONAL
2022-11-14
2026-12-31
Brief Summary
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Detailed Description
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M\&C-Y is a group-based exercise (active rehabilitation) program designed for youth with persistent post-concussion symptoms (PPCS) to exercise, learn new skills to manage concussion symptoms in daily life, and meet others with similar experiences. Program elements include: Goal setting, icebreakers, a circuit exercise program, and psychoeducation about concussion and symptoms. M\&C-Y will be delivered/supervised by an Occupational Therapist and Physiotherapist with experience working with youth with concussion.
M\&C-C is a group-based psychoeducational support group designed for caregivers who have a child experiencing PPCS. It is designed to provide education centered around advocacy skills, familial and child well-being, and parenting support. M\&C-C will be delivered by a Clinical Neuropsychologist and Social Worker with experience working with youth with concussion.
The M\&C-Y \& M\&C-C intervention will both run for six weeks in one of three conditions ((1) direct treatment; (2) virtual treatment; (3) waitlist control). The treatment sessions run once a week and last approximately one hour. Participants will provide electronic consent and complete the pre-intervention (baseline/week 1) measures one week before the intervention begins. Data collection will also occur post-intervention (week 8) and at 3-month follow-up.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Move&Connect-Youth
* Sessions run weekly at the Bloorview Research Institute by a registered physiotherapist and occupational therapist for one hour. Participants will provide electronic consent and complete the pre-intervention measures one week before the intervention begins. Data collection will also occur on week 8 (post intervention) and at 3-month follow-up.
* Weekly sessions will include an active rehabilitation component including exercises focused on cardiovascular fitness, balance, co-ordination and strength.
* Weekly sessions will also include an educational component through focused discussions on topics including headache management, stress coping skills, fatigue management, advocacy skills, and goal setting.
* Data collection sessions will include a series of questionnaires and surveys to acquire consent, demographic information, and assess pre-post changes in concussion symptoms, self-efficacy, quality of life, mental health and social support.
Exercise Circuits
Weekly exercise circuits with a focus on strength, balance, cardiovascular fitness, and coordination
Goal Setting
Goal setting focused on the management of persistent post concussion symptoms, exercise, and engagement in daily activities
Psychoeducation-Youth
Targeted educational sessions with a focus on the physical, cognitive, and psychological implications of persistent post-concussion symptoms.
Move&Connect-Youth-Virtual
* Sessions run weekly via Zoom videoconferencing by a registered physiotherapist and occupational therapist for one hour. Participants will provide electronic consent and complete the pre-intervention measures one week before the intervention begins. Data collection will also occur on week 8 (post intervention) and at 3-month follow-up.
* Weekly sessions taking place over Zoom will include an active rehabilitation component including exercises focused on cardiovascular fitness, balance, co-ordination and strength.
* Weekly sessions will also include an educational component through focused discussions on topics including headache management, stress coping skills, mood coping skills, fatigue management, advocacy skills, and goal setting.
* Data collection sessions will include a series of questionnaires and surveys to acquire consent, demographic information, and assess pre-post changes in concussion symptoms, self-efficacy, quality of life, mental health and social support.
Exercise Circuits
Weekly exercise circuits with a focus on strength, balance, cardiovascular fitness, and coordination
Goal Setting
Goal setting focused on the management of persistent post concussion symptoms, exercise, and engagement in daily activities
Psychoeducation-Youth
Targeted educational sessions with a focus on the physical, cognitive, and psychological implications of persistent post-concussion symptoms.
Move&Connect-Youth Waitlist control
The control group will be recruited from the waitlist for the Persistent Concussion Clinic and the Early Care Concussion Clinic at Holland Bloorview, in addition to partnered community medical offices and organizations.
For the control group, the research assistant will schedule the participants first session to obtain consent and provide youth/caregivers with week 1 questionnaires. At this time, the participants will be able to ask any questions related to the study. After eight weeks the control group will be asked to complete the post measures in order to mimic the length of the intervention. The control group will then be given the opportunity to enroll in one of the intervention arms of the Move\&Connect study. They will then follow the same approved procedures for the intervention treatment group. Youth and their caregivers will be able to participate as waitlist controls without completing the intervention, if they choose.
Waitlist Control Surveys
Surveys completed in week 1, and 8 for a subset of participants who are not involved in the study intervention to mirror study timeline and serve as control data for outcome measures assessed during experimental intervention
Move&Connect-Caregiver
* The treatment sessions run once a week at the Bloorview Research Institute and last approximately one hour. Participants will provide electronic consent and complete the pre-intervention measures one week before the intervention begins. Data collection will also occur on week 8 (post intervention) and at 3-month follow-up.
* Caregivers will participate in a group-based psychoeducational support group with sessions consisting of focused discussions on topics including: the ripple effect, school advocacy, child well-being, family functioning, parenting, and stress \& daily challenges. The sessions will be run by a clinical neuropsychologist and social worker.
* Data collection sessions will include a series of questionnaires and surveys to acquire consent, demographic information, and assess pre-post changes in their youth's concussion symptoms, and mental health, as well as parental self-efficacy, quality of life, mental health and social support.
Psychoeducation-Caregiver
Psychoeducational sessions focused on social support, in addition to addressing the implications of caring for youth experiencing persistent post concussion symptoms
Move&Connect-Caregiver-Virtual
* The treatment sessions run once a week using Zoom videoconferencing and last approximately one hour. Participants will provide electronic consent and complete the pre-intervention measures one week before the intervention begins. Data collection will also occur on week 8 (post intervention) and at 3-month follow-up.
* Caregivers will participate in a group-based psychoeducational support group with sessions consisting of focused discussions on topics including: the ripple effect, school advocacy, child well-being, family functioning, parenting, and stress \& daily challenges. The sessions will be run by a clinical neuropsychologist and social worker.
* Data collection sessions will include a series of questionnaires and surveys to acquire consent, demographic information, and assess pre-post changes in their youth's concussion symptoms, and mental health, as well as parental self-efficacy, quality of life, mental health and social support.
Psychoeducation-Caregiver
Psychoeducational sessions focused on social support, in addition to addressing the implications of caring for youth experiencing persistent post concussion symptoms
Move&Connect-Caregiver Waitlist control
The control group will be recruited from the waitlist for the Persistent Concussion Clinic and the Early Care Concussion Clinic at Holland Bloorview, in addition to partnered community medical offices and organizations.
For the control group, the research assistant will schedule the participants first session to obtain consent and provide youth/caregivers with week 1 questionnaires. At this time, the participants will be able to ask any questions related to the study. After eight weeks the control group will be asked to complete the post measures in order to mimic the length of the intervention. The control group will then be given the opportunity to enroll in one of the intervention arms of the Move\&Connect study. They will then follow the same approved procedures for the intervention treatment group. Youth and their caregivers will be able to participate as waitlist controls without completing the intervention, if they choose.
Waitlist Control Surveys
Surveys completed in week 1, and 8 for a subset of participants who are not involved in the study intervention to mirror study timeline and serve as control data for outcome measures assessed during experimental intervention
Interventions
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Exercise Circuits
Weekly exercise circuits with a focus on strength, balance, cardiovascular fitness, and coordination
Goal Setting
Goal setting focused on the management of persistent post concussion symptoms, exercise, and engagement in daily activities
Psychoeducation-Youth
Targeted educational sessions with a focus on the physical, cognitive, and psychological implications of persistent post-concussion symptoms.
Psychoeducation-Caregiver
Psychoeducational sessions focused on social support, in addition to addressing the implications of caring for youth experiencing persistent post concussion symptoms
Waitlist Control Surveys
Surveys completed in week 1, and 8 for a subset of participants who are not involved in the study intervention to mirror study timeline and serve as control data for outcome measures assessed during experimental intervention
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with a concussion by a physician or nurse practitioner and are experiencing concussion symptoms for ≥ 4 weeks post concussion.
* Willing to engage in weekly sessions
* Have access to reliable internet connection.
* Caregiver to youth experiencing PPCS
* Fluent in English
* Have the capacity to consent
* Have access to a reliable internet connection.
Exclusion Criteria
* Unable to provide informed consent.
* Diagnosed with autism spectrum disorder (ASD), a physical disability (requiring a-mobility device) and and/or intellectual disabilities.
* Diagnosed with a functional neurological disorder (e.g. conversion disorder, somatization, personality disorder) or an acute psychiatric condition (e.g. schizophrenia, suicidality, or a recent hospital admission for another psychiatric condition).
• Diagnosed with an acute psychiatric condition that resulted in a recent hospital admission (e.g. schizophrenia, suicidality, etc.).
8 Years
21 Years
ALL
Yes
Sponsors
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Canadian Institutes of Health Research (CIHR)
OTHER_GOV
Holland Bloorview Kids Rehabilitation Hospital
OTHER
Responsible Party
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Shannon Scratch
Clinical Neuropsychologist
Principal Investigators
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Shannon Scratch, PhD, C Psych
Role: PRINCIPAL_INVESTIGATOR
Holland Bloorview Kids Rehabilitation Hospital
Andrea Hickling, MScOT, OT Reg. (Ont.)
Role: STUDY_DIRECTOR
Holland Bloorview Kids Rehabilitation Hospital
Locations
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Holland Bloorview Kids Rehabilitation Hospital
East York, Ontario, Canada
Countries
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Other Identifiers
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22-0513
Identifier Type: -
Identifier Source: org_study_id
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