Move&Connect: A Program for Youth With Concussion and Their Caregivers. (NCT05631301) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Move&Connect: A Program for Youth With Concussion and Their Caregivers.
Canada150 participantsStarted 2022-11-14
Plain-language 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.
Who can participate
Age range
8 Years – 21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria Youth:
* 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.
Inclusion Criteria Caregivers:
* Caregiver to youth experiencing PPCS
* Fluent in English
* Have the capacity to consent
* Have access to a reliable internet connection.
Exclusion Criteria Youth:
* 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).
Exclusion Criteria Caregivers:
• Diagnosed with an acute psychiatric condition that resulted in a recent hospital admission (e.g. schizophrenia, suicidality, etc.).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1The Move&Connect program is no longer enrolling new participants — does that mean this isn't an option for us right now, and are there similar programs for youth with post-concussion syndrome that we could look into instead?
2This trial is measuring things like depression, anxiety, and how the whole family is functioning, not just the physical symptoms of concussion — does that match what you think my child most needs help with right now?
3The program seems to involve both the young person and their caregiver working together over about 8 weeks — how realistic is that kind of time commitment for our situation, and would you consider it a good fit alongside any other treatment we're already doing?
4Since this is listed as 'Phase NA,' meaning it's likely a behavioral or program-based study rather than a drug trial, what does that tell us about the kinds of risks or unknowns we'd be thinking about compared to a more traditional medical treatment?
5If my child's biggest struggles right now are returning to school and daily activities, does the Canadian Occupational Performance Measure — one of the main things this study tracks — suggest this program was designed to address exactly those kinds of goals?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline Canadian Occupational Performance Measure at 8 weeks and 3-month follow up
Timeframe: Baseline, 8 weeks, 3-month follow-up
2
Change from baseline Health and Behavior Inventory at 8-weeks and 3-month follow up
Timeframe: Baseline, 8 Weeks, 3-month follow-up
3
Change from baseline Family Assessment Device-General Functioning at 8-weeks and 3-month follow up
Timeframe: Baseline, 8 weeks, 3 month follow-up
4
Change from baseline Patient-Reported Outcomes Measurement Information System Bank v1.0- Depression at 8-weeks and 3-month follow up
Timeframe: Baseline, 8 weeks, 3-month follow-up
5
Change from baseline Patient-Reported Outcomes Measurement Information System Bank v1.0- Anxiety at 8-weeks and 3-month follow up