Post-Concussion SyndromeNCT05631301
Move&Connect: A Program for Youth With Concussion and Their Caregivers.
A study testing Exercise Circuits, Goal Setting and Psychoeducation-Youth in people with Post-Concussion Syndrome, run by Holland Bloorview Kids Rehabilitation Hospital at 1 site in Canada.
Trial summary
Move\&Connect is an interdisciplinary group-based program co-designed with youth and caregivers that provides skills training, mental health support, and psychoeducation to caregivers and combines these tenets with active rehabilitation for youth with concussion. Read more about this study
- Who is it for?
- Ages 8 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-Concussion Syndrome
- What is being tested?
- Exercise Circuits, Goal Setting and Psychoeducation-Youth
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- 14 Nov 2022to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Between the ages of 8-21 years old with capacity to provide consent/assent.
- 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.
Who cannot join
- Unable to read and speak English
- 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.).
Trial locations and contacts
1 site in 1 country.
Canada1 site
Holland Bloorview Kids Rehabilitation Hospital
East York, Ontario, M4G 1R8
About this study
Official title: Move&Connect: A Holistic Interdisciplinary Program of Care for Youth Experiencing Persistent Symptoms Post-concussion and Their Caregivers
Move\&Connect is an interdisciplinary group-based program co-designed with youth and caregivers that provides skills training, mental health support, and psychoeducation to caregivers and combines these tenets with active rehabilitation for youth with concussion.
Read the detailed description
The overall purpose of this project is to pilot the Move\&Connect intervention to examine intervention effects of both Move\&Connect youth (M\&C-Y) and caregiver (M\&C-C) arms in comparison to waitlist control when conducted either virtually or in-person.
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
- Post-Concussion Syndrome
- Being tested
- Exercise Circuits, Goal Setting, Psychoeducation-Youth, Psychoeducation-Caregiver, Waitlist Control Surveys
- Keywords
- Concussion, Rehabilitation, Exercise, Education
- Medical subject headings
- Post-Concussion Syndrome, Brain Concussion, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise CircuitsOther
Weekly exercise circuits with a focus on strength, balance, cardiovascular fitness, and coordination
Goal SettingBehavioural
Goal setting focused on the management of persistent post concussion symptoms, exercise, and engagement in daily activities
Psychoeducation-YouthBehavioural
Targeted educational sessions with a focus on the physical, cognitive, and psychological implications of persistent post-concussion symptoms.
Psychoeducation-CaregiverBehavioural
Psychoeducational sessions focused on social support, in addition to addressing the implications of caring for youth experiencing persistent post concussion symptoms
Waitlist Control SurveysOther
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
| Study group | Role | What they receive |
|---|---|---|
| Move&Connect-Youth | Experimental | * 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. Receives: Other: Exercise Circuits; Behavioral: Goal Setting; Behavioral: Psychoeducation-Youth |
| Move&Connect-Youth-Virtual | Experimental | * 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. Receives: Other: Exercise Circuits; Behavioral: Goal Setting; Behavioral: Psychoeducation-Youth |
| Move&Connect-Youth Waitlist control | Other | 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. Receives: Other: Waitlist Control Surveys |
| Move&Connect-Caregiver | Experimental | * 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. Receives: Behavioral: Psychoeducation-Caregiver |
| Move&Connect-Caregiver-Virtual | Experimental | * 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. Receives: Behavioral: Psychoeducation-Caregiver |
| Move&Connect-Caregiver Waitlist control | Other | 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. Receives: Other: Waitlist Control Surveys |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Canadian Occupational Performance Measure at 8 weeks and 3-month follow up
An evidence-based outcome measure designed to capture a client's self-perception of performance in everyday living (satisfaction in self-care, productivity and leisure). It assists therapists in using a client-centred approach to service delivery by indicating the family's priorities.
Measured: Baseline, 8 weeks, 3-month follow-up
Change from baseline Health and Behavior Inventory at 8-weeks and 3-month follow up
A 20-item self-report form that focuses on concussion symptoms in the cognitive, emotional, and somatic domains. Questions are scored on a scale from 0-3 with higher scores indicating higher symptom frequency.
Measured: Baseline, 8 Weeks, 3-month follow-up
Change from baseline Family Assessment Device-General Functioning at 8-weeks and 3-month follow up
A 12-item measure of family functioning. Each item is a statement about a family and participants rate how well it describes their own family. Each item is scored based on the level of agreement with each statement with four options from strongly agree, to strongly disagree
Measured: Baseline, 8 weeks, 3 month follow-up
Change from baseline Patient-Reported Outcomes Measurement Information System Bank v1.0- Depression at 8-weeks and 3-month follow up
A 28-item self-report form that focuses on negative mood, social cognition and decreased positive affect and engagement. Each item is scored on a scale from 1-5 with higher scores indicating increased frequency of depressive symptoms
Measured: Baseline, 8 weeks, 3-month follow-up
Change from baseline Patient-Reported Outcomes Measurement Information System Bank v1.0- Anxiety at 8-weeks and 3-month follow up
A 29-item self-report form that focuses on feelings of fear, anxiousness, hyperarousal, and somatic symptoms related to arousal. Each item is scored on a scale from 1-5 with higher scores indicating increased frequency of symptoms of anxiety
Measured: Baseline, 8 weeks, 3-month follow-up
Secondary outcomes (11)
Semi-Structured Exit Interview
To assess perceived changes in persistent concussion symptoms, education, and social support a participant may/may not have experienced during the intervention and to gather feedback on the structure and delivery of the intervention
Measured: Week 8
Change from baseline Brief Illness Perception Questionnaire at 8-weeks and 3-month follow up
An 8-item questionnaire to assess cognitive and emotional representations of illness.
Each item represents one domain of illness perception and each item is scored on a scale from 1-10. Items 3,4, and 7 are reverse scored and all scores are added together with a higher score indicating a more threatening view of illness
Measured: baseline, week 8, 3-month follow-up
Change from baseline Patient-Reported Outcomes Measurement Information System Pediatric Bank v2.0- Depression at 8-weeks and 3-month follow up
A 14-item self-report form that focuses on negative mood, social cognition and decreased positive affect and engagement. Each item is scored on a scale from 1-5 with higher scores indicating increased frequency of depressive symptoms
Measured: baseline, week 8, 3-month follow-up
Change from baseline Patient-Reported Outcomes Measurement Information System Pediatric Bank v2.0- Anxiety at 8-weeks and 3-month follow up
A 15-item self-report form that focuses on feelings of fear, anxiousness, hyperarousal, and somatic symptoms related to arousal. Each item is scored on a scale from 1-5 with higher scores indicating increased frequency of symptoms of anxiety
Measured: baseline, week 8, 3-month follow-up
Change from baseline Patient-Reported Outcomes Measurement Information System Pediatric Bank v2.0 Fatigue Short form 10a at 8-weeks and 3-month follow up
Assesses a range of symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion. Each item is scored on a scale from 1-5 with higher scores indicating increased frequency of symptoms of fatigue
Measured: baseline, week 8, 3-month follow-up
Change from baseline Healthy Lifestyle and Behaviours Checklist at 8-weeks and 3-month follow up
A self-report questionnaire of an individual's physical activity, and sleep behaviors.
Measured: baseline, week 8, 3-month follow-up
Change from baseline Progressive Activities of Controlled Exertion- Self Efficacy at 8-weeks and 3-month follow up
A 17-item measure that assesses children's perceptions of self-efficacy for an active approach toward pediatric concussion recovery. Each item is scored on a scale of 1-10 with higher scores indicating greater perceived self efficacy.
Measured: baseline, week 8, 3-month follow-up
Change from baseline University of California, Los Angeles Loneliness Scale at 8-weeks and 3-month follow up
A 20-item scale designed to measure one's subjective feelings of loneliness as well as feelings of social isolation. each item is scored on a scale of 1 (never) to 4 (often). Items 1, 5, 6, 9, 10, 15, 16, 19, 20 are all reverse scored. Higher total scores indicate elevated feelings loneliness and likelihood of interpersonal problems.
Measured: baseline, week 8, 3-month follow-up
Change from baseline Pediatric Quality of Life Index: Generic Core Scales at 8-weeks and 3-month follow up
a 23-item measure that assesses the core dimensions of health as delineated by the World Health Organization including Physical Functioning, Emotional Functioning, Social Functioning and School Functioning. Each item is scored from 0 (never) to 4 (almost always) with higher scores representing worse outcomes in each domain.
Measured: baseline, week 8, 3-month follow-up
Change from baseline Patient-Reported Outcomes Measurement Information System Parent Proxy Bank v2.0-Depressive Symptoms short form 6a at 8-weeks and 3-month follow up
A 6 item parent proxy-report that focuses on negative mood, social cognition and decreased positive affect and engagement in their child. Each item is scored on a scale from 1-5 with higher scores indicating increased frequency of depressive symptoms reported in their child
Measured: baseline, week 8, 3-month follow-up
Change from baseline Patient-Reported Outcomes Measurement Information System Parent Proxy Bank v2.0 - Anxiety short form 8a at 8-weeks and 3-month follow up.
A 8 item parent proxy-report form that focuses on feelings of fear, anxiousness, hyperarousal, and somatic symptoms related to arousal in their child. Each item is scored on a scale from 1-5 with higher scores indicating increased frequency of symptoms of anxiety in their child
Measured: baseline, week 8, 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study start14 Nov 2022
- Primary completion15 Jul 2026
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Concussion SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The M\&C-Youth \& M\&C-Caregiver intervention will both run for six weeks in one of three groups (Two treatments: direct, virtual; One control: waitlist). The treatment sessions run once a week and last approximately one hour. Individuals initially enrolled in the waitlist control arm will be subsequently be invited to participate in the intervention arm of the study.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Holland Bloorview Kids Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Shannon Scratch, Holland Bloorview Kids Rehabilitation Hospital
- Investigators
- Shannon Scratch, PhD, C Psych, Principal investigator, Holland Bloorview Kids Rehabilitation HospitalAndrea Hickling, MScOT, OT Reg. (Ont.), Study director, Holland Bloorview Kids Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05631301
- Sponsor's protocol ID
- 22-0513
- Status last verified
- Oct 2026
- First submitted
- 28 Oct 2022
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Move&Connect: A Holistic Interdisciplinary Program of Care for Youth Experiencing Persistent Symptoms Post-concussion and Their Caregivers
- ClinicalTrials.gov ID
- NCT05631301
- Acronym / sponsor ID
- 22-0513
- Conditions
- Post-Concussion Syndrome
- Keywords
- Concussion, Rehabilitation, Exercise, Education
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Holland Bloorview Kids Rehabilitation HospitalUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 14 Nov 2022 (actual)
- Primary completion
- 15 Jul 2026 (actual)
- Study completion
- Dec 2027 (estimated)
- First posted
- 30 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Move\&Connect is an interdisciplinary group-based program co-designed with youth and caregivers that provides skills training, mental health support, and psychoeducation to caregivers and combines these tenets with active rehabilitation for youth with concussion.
Detailed description
The overall purpose of this project is to pilot the Move\&Connect intervention to examine intervention effects of both Move\&Connect youth (M\&C-Y) and caregiver (M\&C-C) arms in comparison to waitlist control when conducted either virtually or in-person.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- The M\&C-Youth \& M\&C-Caregiver intervention will both run for six weeks in one of three groups (Two treatments: direct, virtual; One control: waitlist). The treatment sessions run once a week and last approximately one hour. Individuals initially enrolled in the waitlist control arm will be subsequently be invited to participate in the intervention arm of the study.
| Arm | Type | Receives |
|---|---|---|
| Move&Connect-Youth | Experimental | Other: Exercise Circuits, Behavioral: Goal Setting, Behavioral: Psychoeducation-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. |
| Move&Connect-Youth-Virtual | Experimental | Other: Exercise Circuits, Behavioral: Goal Setting, Behavioral: Psychoeducation-Youth* 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. |
| Move&Connect-Youth Waitlist control | Other | Other: Waitlist Control SurveysThe 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. |
| Move&Connect-Caregiver | Experimental | Behavioral: Psychoeducation-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. |
| Move&Connect-Caregiver-Virtual | Experimental | Behavioral: Psychoeducation-Caregiver* 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. |
| Move&Connect-Caregiver Waitlist control | Other | Other: Waitlist Control SurveysThe 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. |
Who may qualify
- Ages
- 8 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Between the ages of 8-21 years old with capacity to provide consent/assent.
- 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
Key exclusion criteria (5 listed)
- Unable to read and speak English
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise CircuitsWeekly exercise circuits with a focus on strength, balance, cardiovascular fitness, and coordination | Other | Move&Connect-Youth, Move&Connect-Youth-Virtual |
| Goal SettingGoal setting focused on the management of persistent post concussion symptoms, exercise, and engagement in daily activities | Behavioural | Move&Connect-Youth, Move&Connect-Youth-Virtual |
| Psychoeducation-YouthTargeted educational sessions with a focus on the physical, cognitive, and psychological implications of persistent post-concussion symptoms. | Behavioural | Move&Connect-Youth, Move&Connect-Youth-Virtual |
| Psychoeducation-CaregiverPsychoeducational sessions focused on social support, in addition to addressing the implications of caring for youth experiencing persistent post concussion symptoms | Behavioural | Move&Connect-Caregiver, Move&Connect-Caregiver-Virtual |
| Waitlist Control SurveysSurveys 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 | Other | Move&Connect-Caregiver Waitlist control, Move&Connect-Youth Waitlist control |
Primary outcome
Change from baseline Canadian Occupational Performance Measure at 8 weeks and 3-month follow up
Time frame: Baseline, 8 weeks, 3-month follow-up
An evidence-based outcome measure designed to capture a client's self-perception of performance in everyday living (satisfaction in self-care, productivity and leisure). It assists therapists in using a client-centred approach to service delivery by indicating the family's priorities.
Change from baseline Health and Behavior Inventory at 8-weeks and 3-month follow up
Time frame: Baseline, 8 Weeks, 3-month follow-up
A 20-item self-report form that focuses on concussion symptoms in the cognitive, emotional, and somatic domains. Questions are scored on a scale from 0-3 with higher scores indicating higher symptom frequency.
Change from baseline Family Assessment Device-General Functioning at 8-weeks and 3-month follow up
Time frame: Baseline, 8 weeks, 3 month follow-up
A 12-item measure of family functioning. Each item is a statement about a family and participants rate how well it describes their own family. Each item is scored based on the level of agreement with each statement with four options from strongly agree, to strongly disagree
Change from baseline Patient-Reported Outcomes Measurement Information System Bank v1.0- Depression at 8-weeks and 3-month follow up
Time frame: Baseline, 8 weeks, 3-month follow-up
A 28-item self-report form that focuses on negative mood, social cognition and decreased positive affect and engagement. Each item is scored on a scale from 1-5 with higher scores indicating increased frequency of depressive symptoms
Change from baseline Patient-Reported Outcomes Measurement Information System Bank v1.0- Anxiety at 8-weeks and 3-month follow up
Time frame: Baseline, 8 weeks, 3-month follow-up
A 29-item self-report form that focuses on feelings of fear, anxiousness, hyperarousal, and somatic symptoms related to arousal. Each item is scored on a scale from 1-5 with higher scores indicating increased frequency of symptoms of anxiety
11 secondary outcomes
Semi-Structured Exit Interview
Time frame: Week 8
Change from baseline Brief Illness Perception Questionnaire at 8-weeks and 3-month follow up
Time frame: baseline, week 8, 3-month follow-up
Change from baseline Patient-Reported Outcomes Measurement Information System Pediatric Bank v2.0- Depression at 8-weeks and 3-month follow up
Time frame: baseline, week 8, 3-month follow-up
Change from baseline Patient-Reported Outcomes Measurement Information System Pediatric Bank v2.0- Anxiety at 8-weeks and 3-month follow up
Time frame: baseline, week 8, 3-month follow-up
Change from baseline Patient-Reported Outcomes Measurement Information System Pediatric Bank v2.0 Fatigue Short form 10a at 8-weeks and 3-month follow up
Time frame: baseline, week 8, 3-month follow-up
Change from baseline Healthy Lifestyle and Behaviours Checklist at 8-weeks and 3-month follow up
Time frame: baseline, week 8, 3-month follow-up
Change from baseline Progressive Activities of Controlled Exertion- Self Efficacy at 8-weeks and 3-month follow up
Time frame: baseline, week 8, 3-month follow-up
Change from baseline University of California, Los Angeles Loneliness Scale at 8-weeks and 3-month follow up
Time frame: baseline, week 8, 3-month follow-up
Change from baseline Pediatric Quality of Life Index: Generic Core Scales at 8-weeks and 3-month follow up
Time frame: baseline, week 8, 3-month follow-up
Change from baseline Patient-Reported Outcomes Measurement Information System Parent Proxy Bank v2.0-Depressive Symptoms short form 6a at 8-weeks and 3-month follow up
Time frame: baseline, week 8, 3-month follow-up
Change from baseline Patient-Reported Outcomes Measurement Information System Parent Proxy Bank v2.0 - Anxiety short form 8a at 8-weeks and 3-month follow up.
Time frame: baseline, week 8, 3-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shannon Scratch, PhD, C Psych principal investigator
Holland Bloorview Kids Rehabilitation Hospital
Andrea Hickling, MScOT, OT Reg. (Ont.) study director
Holland Bloorview Kids Rehabilitation Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Circuits, Goal Setting and Psychoeducation-Youth in people with Post-Concussion Syndrome, run by Holland Bloorview Kids Rehabilitation Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Canadian Occupational Performance Measure at 8 weeks and 3-month follow up (time frame: Baseline, 8 weeks, 3-month follow-up). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.