search
Back to results

Feasibility of a Cognitive Intervention for Youth Post Concussion

Primary Purpose

Mild Traumatic Brain Injury, Concussion, Mild

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cognitive Orientation to Occupational Performance (CO-OP)
Sponsored by
Holland Bloorview Kids Rehabilitation Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Traumatic Brain Injury focused on measuring pediatrics, case series, feasibility

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bloorview Research Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention arm

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Change in mood and self-concept (Beck Youth Inventories)
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).
Change in symptoms (Post Concussion Symptom Inventory)
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.

Full Information

First Posted
June 14, 2017
Last Updated
June 22, 2017
Sponsor
Holland Bloorview Kids Rehabilitation Hospital
Collaborators
Ontario Society of Occupational Therapists
search

1. Study Identification

Unique Protocol Identification Number
NCT03195738
Brief Title
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

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
July 25, 2014 (Actual)
Primary Completion Date
March 30, 2016 (Actual)
Study Completion Date
July 1, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Holland Bloorview Kids Rehabilitation Hospital
Collaborators
Ontario Society of Occupational Therapists

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Traumatic Brain Injury, Concussion, Mild
Keywords
pediatrics, case series, feasibility

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Cognitive Orientation to Occupational Performance (CO-OP)
Intervention Description
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 Measure Information:
Title
Change in Occupational Performance and Satisfaction (Canadian Occupational Performance Measure)
Description
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).
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.
Secondary Outcome Measure Information:
Title
Change in mood and self-concept (Beck Youth Inventories)
Description
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).
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.
Title
Change in symptoms (Post Concussion Symptom Inventory)
Description
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.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne W Hunt, PhD
Organizational Affiliation
Bloorview Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bloorview Research Institute
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G1R8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Law, M., Baptiste, S., Carswell, A., McColl, M., Polatajko, H., & Pollack N. (2014). Canadian Occupational Performance Measure (5th ed.). Ottawa: CAOT Publications.
Results Reference
background
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.
Results Reference
background
PubMed Identifier
24739735
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.
Results Reference
background
Citation
Beck, J., Beck, A., Jolly, J., & Steer, R. (2005). Beck Youth Inventories for Children and Adolescents. 2nd Ed. San Antonio: Harcourt Assessment Inc.
Results Reference
background

Learn more about this trial

Feasibility of a Cognitive Intervention for Youth Post Concussion

We'll reach out to this number within 24 hrs