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

Post-Concussion Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05631301
• Other study ID #: 22-0513
• Status: Recruiting
• Phase: N/A
• Start date: November 14, 2022
• Est. completion date: September 2024

Study information

• Verified date: March 2024
• Source: Holland Bloorview Kids Rehabilitation Hospital
• Contact: Andrew J Lovell, MSc
• Phone: 416-425-6220
• Email: alovell[@]hollandbloorview.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 21 Years

Eligibility

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.).

Related Conditions & MeSH terms

• Post-Concussion Syndrome

Intervention

Other:
• Exercise Circuits
Weekly exercise circuits with a focus on strength, balance, cardiovascular fitness, and coordination

Behavioral:
• Goal Setting
Goal setting focused on the management of persistent post concussion symptoms, exercise, and engagement in daily activities
• Psychoeducation-Youth
Targeted educational sessions with a focus on the physical, cognitive, and psychological implications of persistent post-concussion symptoms.
• Psychoeducation-Caregiver
Psychoeducational sessions focused on social support, in addition to addressing the implications of caring for youth experiencing persistent post concussion symptoms

Other:
• Waitlist Control Surveys
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

Locations

Country	Name	City	State
Canada	Holland Bloorview Kids Rehabilitation Hospital	East York	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Holland Bloorview Kids Rehabilitation Hospital	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Satisfaction Survey	To collect general feedback related to the structure and delivery of the Move&Connect intervention	Week 8
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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	Week 8
Secondary	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	baseline, week 8, 3-month follow-up
Secondary	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	baseline, week 8, 3-month follow-up
Secondary	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	baseline, week 8, 3-month follow-up
Secondary	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	baseline, week 8, 3-month follow-up
Secondary	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.	baseline, week 8, 3-month follow-up
Secondary	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.	baseline, week 8, 3-month follow-up
Secondary	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.	baseline, week 8, 3-month follow-up
Secondary	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.	baseline, week 8, 3-month follow-up
Secondary	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	baseline, week 8, 3-month follow-up
Secondary	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	baseline, week 8, 3-month follow-up