Clinical trial NCT05631301: 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
Overall status: RECRUITING
Phase: NA
Conditions: Post-Concussion Syndrome
Keywords: Concussion
Rehabilitation
Exercise
Education
Lead sponsor: Holland Bloorview Kids Rehabilitation Hospital
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2022-11-30
Enrollment: 150
Sex: ALL
Minimum age (years): 8
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.).

Primary outcomes:
measure: Change from baseline Canadian Occupational Performance Measure at 8 weeks and 3-month follow up
timeFrame: Baseline, 8 weeks, 3-month follow-up
measure: Change from baseline Health and Behavior Inventory at 8-weeks and 3-month follow up
timeFrame: Baseline, 8 Weeks, 3-month follow-up
measure: Change from baseline Family Assessment Device-General Functioning at 8-weeks and 3-month follow up
timeFrame: Baseline, 8 weeks, 3 month follow-up
measure: 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
measure: Change from baseline Patient-Reported Outcomes Measurement Information System Bank v1.0- Anxiety at 8-weeks and 3-month follow up
timeFrame: Baseline, 8 weeks, 3-month follow-up
Secondary outcomes:
measure: Semi-Structured Exit Interview
timeFrame: Week 8
measure: Change from baseline Brief Illness Perception Questionnaire at 8-weeks and 3-month follow up
timeFrame: baseline, week 8, 3-month follow-up
measure: Change from baseline Patient-Reported Outcomes Measurement Information System Pediatric Bank v2.0- Depression at 8-weeks and 3-month follow up
timeFrame: baseline, week 8, 3-month follow-up
measure: Change from baseline Patient-Reported Outcomes Measurement Information System Pediatric Bank v2.0- Anxiety at 8-weeks and 3-month follow up
timeFrame: baseline, week 8, 3-month follow-up
measure: 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
timeFrame: baseline, week 8, 3-month follow-up
measure: Change from baseline Healthy Lifestyle and Behaviours Checklist at 8-weeks and 3-month follow up
timeFrame: baseline, week 8, 3-month follow-up
measure: Change from baseline Progressive Activities of Controlled Exertion- Self Efficacy at 8-weeks and 3-month follow up
timeFrame: baseline, week 8, 3-month follow-up
measure: Change from baseline University of California, Los Angeles Loneliness Scale at 8-weeks and 3-month follow up
timeFrame: baseline, week 8, 3-month follow-up
measure: Change from baseline Pediatric Quality of Life Index: Generic Core Scales at 8-weeks and 3-month follow up
timeFrame: baseline, week 8, 3-month follow-up
measure: 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
timeFrame: baseline, week 8, 3-month follow-up
measure: 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.
timeFrame: baseline, week 8, 3-month follow-up
Other outcomes:
measure: Satisfaction Survey
timeFrame: Week 8
Locations:
city: East York
country: Canada
facility: Holland Bloorview Kids Rehabilitation Hospital
state: Ontario
Study officials:
affiliation: Holland Bloorview Kids Rehabilitation Hospital
name: Shannon Scratch, PhD, C Psych
role: PRINCIPAL_INVESTIGATOR
affiliation: Holland Bloorview Kids Rehabilitation Hospital
name: Andrea Hickling, MScOT, OT Reg. (Ont.)
role: STUDY_DIRECTOR
References: