Feasibility of a Cognitive Intervention for Youth Post Concussion

NCT03195738 | Completed

• 1 other identifier: REB14-485
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Mild Traumatic Brain Injury; Concussion, Mild

Keywords

pediatrics; case series; feasibility

Outcome Measures

Primary Outcomes (1)

• 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).

  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 (2)

• 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.

• 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.

Study Arms (1)

Intervention arm

EXPERIMENTAL

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)

Interventions

Cognitive Orientation to Occupational Performance (CO-OP) OTHER

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.

Intervention arm

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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;
• years of age;
• no concurrent serious medical or psychiatric diagnoses.
• has a parent who can support participation and participate in a post intervention interview

You may not qualify if:

• non English speaking

Sponsors & Collaborators

• Holland Bloorview Kids Rehabilitation Hospital: lead
• Ontario Society of Occupational Therapists: collaborator

Study Sites (1)

Bloorview Research Institute

Toronto, Ontario, M5G1R8, Canada

Location

Related Publications (4)

• Law, M., Baptiste, S., Carswell, A., McColl, M., Polatajko, H., & Pollack N. (2014). Canadian Occupational Performance Measure (5th ed.). Ottawa: CAOT Publications.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 24739735 BACKGROUND

• Beck, J., Beck, A., Jolly, J., & Steer, R. (2005). Beck Youth Inventories for Children and Adolescents. 2nd Ed. San Antonio: Harcourt Assessment Inc.

  BACKGROUND

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Anne W Hunt, PhD

  Bloorview Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2017
• First Posted: June 22, 2017
• Study Start: July 25, 2014
• Primary Completion: March 30, 2016
• Study Completion: July 1, 2016
• Last Updated: June 23, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)