Mild Traumatic Brain InjuryNCT03195738

Feasibility of a Cognitive Intervention for Youth Post Concussion

A study testing Cognitive Orientation to Occupational Performance (CO-OP) in people with Mild Traumatic Brain Injury and Concussion, Mild, run by Holland Bloorview Kids Rehabilitation Hospital at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 12 to 18 years
Conditions the study is for: Mild Traumatic Brain Injury, Concussion, Mild
What is being tested?: Cognitive Orientation to Occupational Performance (CO-OP)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 3 participants
Where: 1 siteCanada
Study dates: 25 Jul 2014to 1 Jul 2016
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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

Who cannot join

non English speaking

Trial locations and contacts

1 site in 1 country.

Canada1 site

Bloorview Research Institute
Toronto, Ontario, M5G1R8

Other trials in Canada

About this study

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

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

Read the 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.

Conditions: Mild Traumatic Brain Injury, Concussion, Mild
Being tested: Cognitive Orientation to Occupational Performance (CO-OP)
Keywords: pediatrics, case series, feasibility
Medical subject headings: Brain Concussion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.

Study groups in NCT03195738
Study group	Role	What they receive
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. Receives: Other: Cognitive Orientation to Occupational Performance (CO-OP)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Jul 20141 Jul 2016

First posted22 Jun 2017
Study start25 Jul 2014
Primary completion30 Mar 2016
Study completion1 Jul 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Mild Traumatic Brain InjuryStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 3 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03195738
Sponsor's protocol ID: REB14-485
Status last verified: Jun 2017
First submitted: 14 Jun 2017
Last updated: 23 Jun 2017
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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.
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.
PubMed 24739735
Beck, J., Beck, A., Jolly, J., & Steer, R. (2005). Beck Youth Inventories for Children and Adolescents. 2nd Ed. San Antonio: Harcourt Assessment Inc.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Mild Traumatic Brain Injury trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Feasibility and Effects of the CO-OP Approach for Post-concussion Rehabilitation
ClinicalTrials.gov ID: NCT03195738
Acronym / sponsor ID: REB14-485
Conditions: Mild Traumatic Brain Injury, Concussion, Mild
Keywords: pediatrics, case series, feasibility
Study type: Interventional
Recruitment status: Completed
Enrolment: 3 participants (actual)
Lead sponsor: Holland Bloorview Kids Rehabilitation HospitalUniversity, hospital or other
Collaborators: Ontario Society of Occupational Therapists
Study start: 25 Jul 2014 (actual)
Primary completion: 30 Mar 2016 (actual)
Study completion: 1 Jul 2016 (actual)
First posted: 22 Jun 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Intervention arm	Experimental	Other: Cognitive Orientation to Occupational Performance (CO-OP)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.

Who may qualify

Ages: 12 to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (1 listed)

non English speaking

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Other	Intervention arm

Primary outcome

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).

2 secondary outcomes

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.
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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2017.
BackgroundLaw, M., Baptiste, S., Carswell, A., McColl, M., Polatajko, H., & Pollack N. (2014). Canadian Occupational Performance Measure (5th ed.). Ottawa: CAOT Publications.
BackgroundMcColl, 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: PubMed 24739735Sady 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.
BackgroundBeck, J., Beck, A., Jolly, J., & Steer, R. (2005). Beck Youth Inventories for Children and Adolescents. 2nd Ed. San Antonio: Harcourt Assessment Inc.
Individual participant dataSharing planned: No

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Not yet recruitingObservational study
Cognitive Effects of Hyperbaric Oxygen Therapy (HBOT) After a Traumatic Brain Injury
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Anne W Hunt, PhD principal investigator

Bloorview Research Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03195738, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2017.