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Active, Not Recruiting

NCT Number: NCT05631301

Move&Connect: A Program for Youth With 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Post-Concussion Syndrome Behavior Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Head Injuries, Closed Motor Activity Nervous System Diseases Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

8 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Holland Bloorview Kids Rehabilitation Hospital

East York, Ontario, M4G 1R8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.).

Treatment and study plan

Exercise Circuits

Other

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

Goal setting

Behavioral

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

Psychoeducation-Youth

Behavioral

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

Psychoeducation-Caregiver

Behavioral

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

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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

  5. 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

Secondary outcomes

  1. Semi-Structured Exit Interview

    Time frame: Week 8

    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

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

    Time frame: baseline, week 8, 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

  3. 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

    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

  4. 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

    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

  5. 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

    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

  6. 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

    A self-report questionnaire of an individual's physical activity, and sleep behaviors.

  7. 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

    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.

  8. 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

    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.

  9. 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

    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.

  10. 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

    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

  11. 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

    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

Other outcomes

  1. Satisfaction Survey

    Time frame: Week 8

    To collect general feedback related to the structure and delivery of the Move&Connect intervention

Sponsors and collaborators

Lead sponsor

Holland Bloorview Kids Rehabilitation Hospital

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

Move&Connect: A Holistic Interdisciplinary Program of Care for Youth Experiencing Persistent Symptoms Post-concussion and Their Caregivers

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Nov 30, 2022
Registry last updated
Oct 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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