Feasibility of a Cognitive Intervention for Youth Post Concussion

Not Applicable

Completed

• Conditions: Concussion, Mild; Mild Traumatic Brain Injury

• Registration Number: NCT03195738
• Lead Sponsor: Holland Bloorview Kids Rehabilitation Hospital

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.

Study Timeline

• Study Start: 2014-07-25
• Primary Completion: 2016-03-30
• Study Completion: 2016-07-01
• Status Verified: 2017-06
• Study First Submitted: 2017-06-14
• Study First Submitted QC: 2017-06-20
• Study First Posted: 2017-06-22
• Last Update Submitted: 2017-06-22
• Last Update Posted: 2017-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in Occupational Performance and Satisfaction (Canadian Occupational Performance Measure)	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 Outcome Measures

Name	Time	Method
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.	The 22-item Post-Concussion Symptom Inventory (PCSI) (Sady, Vaughan, Gioia, 2014) (adolescent version) measures the presence and severity (on a scale of 1 (not a problem)-6 (severe problem)) of concussion symptoms. The PCSI has moderate to good inter-rater reliability (r=0.4 to r=0.5), test-retest reliability (r=0.62 to 0.84) and internal consistency (r=0.72 to 0.93). Higher scores indicate presence of more/worse symptoms.
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.	The Beck Youth Inventories for children and adolescents-Second Edition (BYI-II) (Beck, Beck, Jolly, \& Steer, 2005) provides insight into youth's negative thoughts about their self, life and future, and feelings of sadness, worry, guilt, anger, disruptive behaviors and self-worth. The depression, anxiety and anger inventories were administered. Higher scores are associated with negative affect. Psychometric properties are strong with high internal consistency (Cronbach's alpha coefficients from .91-.96) and test-retest reliability (r=.83 to .93).

Trial Locations

Locations (1)

Bloorview Research Institute; 🇨🇦 Toronto, Ontario, Canada