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

Primary Purpose

Post-Concussion Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Exercise Circuits
Goal Setting
Psychoeducation-Youth
Psychoeducation-Caregiver
Waitlist Control Surveys
Sponsored by
Holland Bloorview Kids Rehabilitation Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-Concussion Syndrome focused on measuring Concussion, Rehabilitation, Exercise, Education

Eligibility Criteria

8 Years - 21 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.).

Sites / Locations

  • Holland Bloorview Kids Rehabilitation HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Other

Experimental

Experimental

Other

Arm Label

Move&Connect-Youth

Move&Connect-Youth-Virtual

Move&Connect-Youth Waitlist control

Move&Connect-Caregiver

Move&Connect-Caregiver-Virtual

Move&Connect-Caregiver Waitlist control

Arm Description

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.

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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
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
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

Secondary Outcome Measures

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
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
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
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
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
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.
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.
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.
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.
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
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

Full Information

First Posted
October 28, 2022
Last Updated
November 25, 2022
Sponsor
Holland Bloorview Kids Rehabilitation Hospital
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT05631301
Brief Title
Move&Connect: A Program for Youth With Concussion and Their Caregivers.
Official Title
Move&Connect: A Holistic Interdisciplinary Program of Care for Youth Experiencing Persistent Symptoms Post-concussion and Their Caregivers
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 14, 2022 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Holland Bloorview Kids Rehabilitation Hospital
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Concussion Syndrome
Keywords
Concussion, Rehabilitation, Exercise, Education

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Move&Connect-Youth
Arm Type
Experimental
Arm Description
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.
Arm Title
Move&Connect-Youth-Virtual
Arm Type
Experimental
Arm Description
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.
Arm Title
Move&Connect-Youth Waitlist control
Arm Type
Other
Arm Description
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.
Arm Title
Move&Connect-Caregiver
Arm Type
Experimental
Arm Description
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.
Arm Title
Move&Connect-Caregiver-Virtual
Arm Type
Experimental
Arm Description
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.
Arm Title
Move&Connect-Caregiver Waitlist control
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Exercise Circuits
Intervention Description
Weekly exercise circuits with a focus on strength, balance, cardiovascular fitness, and coordination
Intervention Type
Behavioral
Intervention Name(s)
Goal Setting
Intervention Description
Goal setting focused on the management of persistent post concussion symptoms, exercise, and engagement in daily activities
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducation-Youth
Intervention Description
Targeted educational sessions with a focus on the physical, cognitive, and psychological implications of persistent post-concussion symptoms.
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducation-Caregiver
Intervention Description
Psychoeducational sessions focused on social support, in addition to addressing the implications of caring for youth experiencing persistent post concussion symptoms
Intervention Type
Other
Intervention Name(s)
Waitlist Control Surveys
Intervention Description
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 Outcome Measure Information:
Title
Change from baseline Canadian Occupational Performance Measure at 8 weeks and 3-month follow up
Description
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.
Time Frame
Baseline, 8 weeks, 3-month follow-up
Title
Change from baseline Health and Behavior Inventory at 8-weeks and 3-month follow up
Description
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.
Time Frame
Baseline, 8 Weeks, 3-month follow-up
Title
Change from baseline Family Assessment Device-General Functioning at 8-weeks and 3-month follow up
Description
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
Time Frame
Baseline, 8 weeks, 3 month follow-up
Title
Change from baseline Patient-Reported Outcomes Measurement Information System Bank v1.0- Depression at 8-weeks and 3-month follow up
Description
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
Time Frame
Baseline, 8 weeks, 3-month follow-up
Title
Change from baseline Patient-Reported Outcomes Measurement Information System Bank v1.0- Anxiety at 8-weeks and 3-month follow up
Description
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
Time Frame
Baseline, 8 weeks, 3-month follow-up
Secondary Outcome Measure Information:
Title
Semi-Structured Exit Interview
Description
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
Time Frame
Week 8
Title
Change from baseline Brief Illness Perception Questionnaire at 8-weeks and 3-month follow up
Description
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
Time Frame
baseline, week 8, 3-month follow-up
Title
Change from baseline Patient-Reported Outcomes Measurement Information System Pediatric Bank v2.0- Depression at 8-weeks and 3-month follow up
Description
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
Time Frame
baseline, week 8, 3-month follow-up
Title
Change from baseline Patient-Reported Outcomes Measurement Information System Pediatric Bank v2.0- Anxiety at 8-weeks and 3-month follow up
Description
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
Time Frame
baseline, week 8, 3-month follow-up
Title
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
Description
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
Time Frame
baseline, week 8, 3-month follow-up
Title
Change from baseline Healthy Lifestyle and Behaviours Checklist at 8-weeks and 3-month follow up
Description
A self-report questionnaire of an individual's physical activity, and sleep behaviors.
Time Frame
baseline, week 8, 3-month follow-up
Title
Change from baseline Progressive Activities of Controlled Exertion- Self Efficacy at 8-weeks and 3-month follow up
Description
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.
Time Frame
baseline, week 8, 3-month follow-up
Title
Change from baseline University of California, Los Angeles Loneliness Scale at 8-weeks and 3-month follow up
Description
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.
Time Frame
baseline, week 8, 3-month follow-up
Title
Change from baseline Pediatric Quality of Life Index: Generic Core Scales at 8-weeks and 3-month follow up
Description
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.
Time Frame
baseline, week 8, 3-month follow-up
Title
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
Description
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
Time Frame
baseline, week 8, 3-month follow-up
Title
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.
Description
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
Time Frame
baseline, week 8, 3-month follow-up
Other Pre-specified Outcome Measures:
Title
Satisfaction Survey
Description
To collect general feedback related to the structure and delivery of the Move&Connect intervention
Time Frame
Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrew J Lovell, MSc
Phone
416-425-6220
Ext
3261
Email
alovell@hollandbloorview.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Hiba Al-Hakeem, MA
Phone
416-425-6220
Ext
3261
Email
halhakeem@hollandbloorview.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shannon Scratch, PhD, C Psych
Organizational Affiliation
Holland Bloorview Kids Rehabilitation Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrea Hickling, MScOT, OT Reg. (Ont.)
Organizational Affiliation
Holland Bloorview Kids Rehabilitation Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Holland Bloorview Kids Rehabilitation Hospital
City
East York
State/Province
Ontario
ZIP/Postal Code
M4G 1R8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shannon E Scratch, PhD, C. Psych
Phone
416-425-6220
Ext
3261
Email
sscratch@hollandbloorview.ca
First Name & Middle Initial & Last Name & Degree
Andrew J Lovell, MSc
Phone
416-425-6220
Ext
3360
Email
alovell@hollandbloorview.ca

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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