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Active Not RecruitingNCT05631301

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

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

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
150 (estimated)
Sponsor
Holland Bloorview Kids Rehabilitation Hospital · Academic / Other
Sex
All
Age
8 Years – 21 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERExercise CircuitsWeekly exercise circuits with a focus on strength, balance, cardiovascular fitness, and coordination
BEHAVIORALGoal SettingGoal setting focused on the management of persistent post concussion symptoms, exercise, and engagement in daily activities
BEHAVIORALPsychoeducation-YouthTargeted educational sessions with a focus on the physical, cognitive, and psychological implications of persistent post-concussion symptoms.
BEHAVIORALPsychoeducation-CaregiverPsychoeducational sessions focused on social support, in addition to addressing the implications of caring for youth experiencing persistent post concussion symptoms
OTHERWaitlist Control SurveysSurveys 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

Timeline

Start date
2022-11-14
Primary completion
2025-12-01
Completion
2026-12-01
First posted
2022-11-30
Last updated
2025-10-07

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT05631301. Inclusion in this directory is not an endorsement.