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Clinical Trials/NCT03195738
NCT03195738
Completed
Not Applicable

Feasibility and Effects of the CO-OP Approach for Post-concussion Rehabilitation

Holland Bloorview Kids Rehabilitation Hospital1 site in 1 country3 target enrollmentJuly 25, 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mild Traumatic Brain Injury
Sponsor
Holland Bloorview Kids Rehabilitation Hospital
Enrollment
3
Locations
1
Primary Endpoint
Change in Occupational Performance and Satisfaction (Canadian Occupational Performance Measure)
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 25, 2014
End Date
July 1, 2016
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Change in Occupational Performance and Satisfaction (Canadian Occupational Performance Measure)

Time Frame: Measure will be administered at baseline, within one week post intervention (i.e. at 8 weeks) and again at 3 month follow up.

A change score of two points is considered clinically significant (McColl, Carswell, Law, Pollock, Baptiste, \& Polatajko 2006). During a semi-structured interview, clients are asked to identify a minimum of five occupational performance issues (OPI's). The five most important OPI's as determined by the client are identified using a ranking scale (1=not important at all to 10=extremely important) and then ranked according to performance and satisfaction with performance using 10 point scales (Performance score of 1=not able to do it to 10=able to do it extremely well; Satisfaction score of 1=not at all satisfied to 10=extremely satisfied).

Secondary Outcomes

  • Change in symptoms (Post Concussion Symptom Inventory)(Measure will be administered at baseline, within one week post intervention (i.e. at 8 weeks) and again at 3 month follow up.)
  • Change in mood and self-concept (Beck Youth Inventories)(Measure will be administered at baseline, within one week post intervention (i.e. at 8 weeks) and again at 3 month follow up.)

Study Sites (1)

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