Move&Connect: A Program for Youth With Concussion and Their Caregivers.

NCT05631301 | Active Not Recruiting

• 1 other identifier: 22-0513
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Post-Concussion Syndrome

Keywords

Concussion; Rehabilitation; Exercise; Education

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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

  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

  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

  Baseline, 8 weeks, 3-month follow-up

Secondary Outcomes (11)

• Semi-Structured Exit Interview

  Week 8

• Change from baseline Brief Illness Perception Questionnaire at 8-weeks and 3-month follow up

  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

  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

  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

  baseline, week 8, 3-month follow-up

Other Outcomes (1)

• Satisfaction Survey

  Week 8

Study Arms (6)

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.

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.

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.

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.

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.

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.

Other: Waitlist Control Surveys

Interventions

Exercise Circuits OTHER

Weekly exercise circuits with a focus on strength, balance, cardiovascular fitness, and coordination

Move&Connect-Youth; Move&Connect-Youth-Virtual

Goal Setting BEHAVIORAL

Goal setting focused on the management of persistent post concussion symptoms, exercise, and engagement in daily activities

Move&Connect-Youth; Move&Connect-Youth-Virtual

Psychoeducation-Youth BEHAVIORAL

Targeted educational sessions with a focus on the physical, cognitive, and psychological implications of persistent post-concussion symptoms.

Move&Connect-Youth; Move&Connect-Youth-Virtual

Psychoeducation-Caregiver BEHAVIORAL

Psychoeducational sessions focused on social support, in addition to addressing the implications of caring for youth experiencing persistent post concussion symptoms

Move&Connect-Caregiver; Move&Connect-Caregiver-Virtual

Waitlist Control Surveys OTHER

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 Waitlist control; Move&Connect-Youth Waitlist control

Eligibility Criteria

• Age: 8 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Holland Bloorview Kids Rehabilitation Hospital: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Holland Bloorview Kids Rehabilitation Hospital

East York, Ontario, M4G 1R8, Canada

Location

MeSH Terms

Conditions

Post-Concussion Syndrome; Brain Concussion; Motor Activity

Interventions

Organizational Objectives

Condition Hierarchy (Ancestors)

Head Injuries, Closed; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries; Wounds, Nonpenetrating; Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Organization and Administration; Health Services Administration

Study Officials

• Shannon Scratch, PhD, C Psych

  Holland Bloorview Kids Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

• Andrea Hickling, MScOT, OT Reg. (Ont.)

  Holland Bloorview Kids Rehabilitation Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Neuropsychologist

Model Details: 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.

Study Record Dates

• First Submitted: October 28, 2022
• First Posted: November 30, 2022
• Study Start: November 14, 2022
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 7, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)