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Feasibility of a Cognitive Intervention for Youth Post Concussion

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ClinicalTrials.gov Identifier: NCT03195738
Recruitment Status : Completed
First Posted : June 22, 2017
Last Update Posted : June 23, 2017
Sponsor:
Collaborator:
Ontario Society of Occupational Therapists
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Mild Traumatic Brain Injury Concussion, Mild Other: Cognitive Orientation to Occupational Performance (CO-OP) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility and Effects of the CO-OP Approach for Post-concussion Rehabilitation
Actual Study Start Date : July 25, 2014
Actual Primary Completion Date : March 30, 2016
Actual Study Completion Date : July 1, 2016

Arm Intervention/treatment
Experimental: Intervention arm
The Cognitive Orientation to Occupational Performance (CO-OP) Approach will be delivered over 10 30-60 minute sessions over a seven week period as follows: 2 sessions/week for 3 weeks, then 1 session per week for 4 weeks. In the CO-OP intervention participants are first assisted to identify 3-5 occupation based goals which will be the focus of the intervention sessions. Over the course of the 10 intervention sessions, participants are guided to learn and practice problem solving using a metacognitive strategy, "Goal-Plan-Do-Check" applied to their self-identified goals. Study therapists use 'guided discovery' an iterative technique to facilitate problem solving by the participant to develop plans to work toward their goals and to evaluate their progress. Intervention takes place in the location that is most meaningful for the participant's selected goal (e.g. home, school, playground etc.). Participants are provided with a work book to track progress.
Other: Cognitive Orientation to Occupational Performance (CO-OP)
In the CO-OP intervention participants are first assisted to identify 3-5 occupation based goals which then become the focus of the intervention sessions. Over the course of the 10 intervention sessions, participants are guided to learn and practice problem solving using a metacognitive strategy, "Goal-Plan-Do-Check" applied to their self-identified goals. Study therapists use 'guided discovery' an iterative technique to facilitate problem solving by the participant to develop plans to work toward their goals and to evaluate their progress. Intervention takes place in the location that is most meaningful for the participant's selected goal (e.g. home, school, playground etc.). Participants are provided with a work book to track progress.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Change in mood and self-concept (Beck Youth Inventories) [ 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. ]
    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).

  2. Change in symptoms (Post Concussion Symptom Inventory) [ 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. ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03195738


Locations
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Canada, Ontario
Bloorview Research Institute
Toronto, Ontario, Canada, M5G1R8
Sponsors and Collaborators
Holland Bloorview Kids Rehabilitation Hospital
Ontario Society of Occupational Therapists
Investigators
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Principal Investigator: Anne W Hunt, PhD Bloorview Research Institute

Publications:
Law, M., Baptiste, S., Carswell, A., McColl, M., Polatajko, H., & Pollack N. (2014). Canadian Occupational Performance Measure (5th ed.). Ottawa: CAOT Publications.
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.
Beck, J., Beck, A., Jolly, J., & Steer, R. (2005). Beck Youth Inventories for Children and Adolescents. 2nd Ed. San Antonio: Harcourt Assessment Inc.

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Responsible Party: Holland Bloorview Kids Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT03195738     History of Changes
Other Study ID Numbers: REB14-485
First Posted: June 22, 2017    Key Record Dates
Last Update Posted: June 23, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Holland Bloorview Kids Rehabilitation Hospital:
pediatrics
case series
feasibility
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Concussion
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Head Injuries, Closed
Wounds, Nonpenetrating