Clinical trial NCT03195738: Feasibility of a Cognitive Intervention for Youth Post Concussion
Official title: Feasibility and Effects of the CO-OP Approach for Post-concussion Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Traumatic Brain Injury
Concussion, Mild
Keywords: pediatrics
case series
feasibility
Lead sponsor: Holland Bloorview Kids Rehabilitation Hospital
Sponsor class: OTHER
Collaborators: name: Ontario Society of Occupational Therapists
First posted: 2017-06-22
Enrollment: 3
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the feasibility and effects of a cognitive intervention for youth following concussion

Detailed description: Concussion, a form of mild traumatic brain injury, is one of the most commonly reported injuries in youth. While most recover quickly, a substantial subset (30-58.5%) report symptoms that persist at one month with a reported 11-14% who continue to report symptoms beyond three months. Currently, there are no evidence-based guidelines for treatment that address occupational (meaningful activity) concerns for youth who are slower to recover post-concussion. It is postulated that a top-down rehabilitation approach with metacognitive strategy training as the core of the intervention might be effective.The Cognitive Orientation to Occupational Performance (CO-OP) Approach is a metacognitive strategy training approach with a growing body of literature supporting it's value in improving participation in meaningful activity and achieving self-selected occupation-based goals for adults with brain injury and youth with moderate to severe brain injury.Given the long-term occupational concerns in youth with persistent post-concussion symptoms, and the lack of evidence based interventions for these youth, it is hypothesized that the CO-OP Approach may facilitate return to meaningful occupation in this population.

Eligibility criteria: Inclusion Criteria:

* concussion diagnosed by a physician;
* presence of at least one post-concussion symptom for three months or more; -experiencing challenges with usual daily activities secondary to post-concussive symptoms;
* able to identify four or more occupation-based goals;
* 12-18 years of age;
* no concurrent serious medical or psychiatric diagnoses.
* has a parent who can support participation and participate in a post intervention interview

Exclusion Criteria:

* non English speaking

Primary outcomes:
measure: Change in Occupational Performance and Satisfaction (Canadian Occupational Performance Measure)
timeFrame: Measure will be administered at baseline, within one week post intervention (i.e. at 8 weeks) and again at 3 month follow up.
Secondary outcomes:
measure: Change in mood and self-concept (Beck Youth Inventories)
timeFrame: Measure will be administered at baseline, within one week post intervention (i.e. at 8 weeks) and again at 3 month follow up.
measure: Change in symptoms (Post Concussion Symptom Inventory)
timeFrame: Measure will be administered at baseline, within one week post intervention (i.e. at 8 weeks) and again at 3 month follow up.
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Bloorview Research Institute
state: Ontario
Study officials:
affiliation: Bloorview Research Institute
name: Anne W Hunt, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Law, M., Baptiste, S., Carswell, A., McColl, M., Polatajko, H., & Pollack N. (2014). Canadian Occupational Performance Measure (5th ed.). Ottawa: CAOT Publications.
citation: McColl, MA., Carswell, A., Law, M., Pollock, N., Baptiste, S., & Polatajko, H. (2006). Research on the Canadian Occupational Performance Measure: an annotated resource. Ottawa: CAOT Publications.
citation: Sady MD, Vaughan CG, Gioia GA. Psychometric characteristics of the postconcussion symptom inventory in children and adolescents. Arch Clin Neuropsychol. 2014 Jun;29(4):348-63. doi: 10.1093/arclin/acu014. Epub 2014 Apr 15.
citation: Beck, J., Beck, A., Jolly, J., & Steer, R. (2005). Beck Youth Inventories for Children and Adolescents. 2nd Ed. San Antonio: Harcourt Assessment Inc.