Care for Post-Concussive Symptoms (CARE4PCS)
Primary Purpose
Concussion
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stepped Care
Sponsored by
About this trial
This is an interventional treatment trial for Concussion
Eligibility Criteria
Inclusion Criteria:
- Between ages 11 and 18
- Have sustained a head impact during sports participation
- Have incurred an onset or increase of at least three post-concussive symptoms following head impact
- Have increased post-concussive symptoms following head impact have continued for at least 4 weeks
- Live with their parents or legal guardians
- Live within commuting distance of Seattle Children's Hospital
- Willing to participate in assessment and treatment
- Have at least one parent/caregiver willing to participate in assessment and treatment
Exclusion Criteria:
- Meet Diagnostic and Statistical Manual of Mental Disorders (DSM - V) criteria for a psychotic disorder or bipolar disorder
- Active suicidality
- Substance dependence
Sites / Locations
- Seattle Childrens Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental
Control
Arm Description
Stepped Care
Usual Care
Outcomes
Primary Outcome Measures
Change in Concussion Symptoms
Health Behavior Inventory Assessment
Change in Depressive Symptoms
PHQ-9
Change in Anxiety Symptoms
PROMIS A-8
Change in Quality of Life
PedsQL
Secondary Outcome Measures
Change in School Functioning
Attendance and Grades
Change in Family Functioning
FAD-GF
Change in Parent Anxiety Symptoms
PROMIS A-8
Change in Parent Depressive Symptoms
PHQ-9
Change in ImPACT Assessment
ImPACT test scores
NIH Toolbox - Dimensional Card Sort Test
Dimensional Card Sort Test scores
Change in NIH Toolbox - Picture Memory Sequence Test
Picture Memory Sequence test scores
Change in King-Devick Test
King-Devick Test scores
Full Information
NCT ID
NCT02268240
First Posted
October 10, 2014
Last Updated
September 16, 2018
Sponsor
Seattle Children's Hospital
Collaborators
University of Washington
1. Study Identification
Unique Protocol Identification Number
NCT02268240
Brief Title
Care for Post-Concussive Symptoms
Acronym
CARE4PCS
Official Title
Care for Post-Concussive Symptoms
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seattle Children's Hospital
Collaborators
University of Washington
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The proposed study is a pilot randomized trial of a stepped collaborative care intervention designed to decrease post-concussive symptoms and improve post-injury functioning among sports-injured youth aged 11-17. Participants with persistent post-concussive symptoms (symptoms persisting at least two months post-injury) will be recruited from Seattle Children's Hospital departments of sports medicine and rehabilitation medicine. Consent and assent will be obtained in-person. Participants will be randomized to receive either the stepped collaborative care intervention, or treatment-as-usual. Participants will be assessed on a range of symptoms and areas of functioning at four time points: 0 months, 1 month, 3 months, and 6 months after enrollment. The primary hypothesis is that the intervention group athletes, when compared to usual care control group athletes, will demonstrate clinically and statistically significant reductions in postconcussive, anxiety, and depressive symptoms over the course of the 6-month study. Secondary analyses will assess the impact of the intervention on functional impairment including missed school days and other academic outcomes. Exploratory analyses will examine MRI findings that are characteristic of postconcussive neuropathology, if available in medical record, as predictors of treatment responses.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Concussion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Stepped Care
Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual Care
Intervention Type
Behavioral
Intervention Name(s)
Stepped Care
Intervention Description
Intervention will include : 1) care management; 2) cognitive-behavioral therapy (CBT); 3) psychiatric medication consultation in addition too receiving standard care through their medical team. Care management will include initial consultation to determine participants' and families' concerns and areas of difficulty, followed by brief interventions to connect them with care providers as needed . If participants do not show adequate symptom reduction, they will be engaged in structured CBT. CBT will be delivered in 4 to 12 structured sessions, each ranging from 30-60 minutes in length. Psychiatric medication consultation will be offered on an as-needed basis for participants not adequately responding to prior stepped care interventions. MD providers with expertise in psychopharmacological treatment of youth will provide consultation for participants' primary care provider regarding the prescription of psychiatric medications.
Primary Outcome Measure Information:
Title
Change in Concussion Symptoms
Description
Health Behavior Inventory Assessment
Time Frame
At enrollment, 1 month, 3 months, and 6 months
Title
Change in Depressive Symptoms
Description
PHQ-9
Time Frame
At enrollment, 1 month, 3 months, and 6 months
Title
Change in Anxiety Symptoms
Description
PROMIS A-8
Time Frame
At enrollment, 1 month, 3 months, and 6 months
Title
Change in Quality of Life
Description
PedsQL
Time Frame
At enrollment, 1 month, 3 months, and 6 months
Secondary Outcome Measure Information:
Title
Change in School Functioning
Description
Attendance and Grades
Time Frame
At enrollment, 1 month, 3 months, and 6 months
Title
Change in Family Functioning
Description
FAD-GF
Time Frame
At enrollment, 1 month, 3 months, and 6 months
Title
Change in Parent Anxiety Symptoms
Description
PROMIS A-8
Time Frame
At enrollment, 1 month, 3 months, and 6 months
Title
Change in Parent Depressive Symptoms
Description
PHQ-9
Time Frame
At enrollment, 1 month, 3 months, and 6 months
Title
Change in ImPACT Assessment
Description
ImPACT test scores
Time Frame
At enrollment and 6 months
Title
NIH Toolbox - Dimensional Card Sort Test
Description
Dimensional Card Sort Test scores
Time Frame
At enrollment and 6 months
Title
Change in NIH Toolbox - Picture Memory Sequence Test
Description
Picture Memory Sequence test scores
Time Frame
At enrollment and 6 months
Title
Change in King-Devick Test
Description
King-Devick Test scores
Time Frame
at enrollment and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Between ages 11 and 18
Have sustained a head impact during sports participation
Have incurred an onset or increase of at least three post-concussive symptoms following head impact
Have increased post-concussive symptoms following head impact have continued for at least 4 weeks
Live with their parents or legal guardians
Live within commuting distance of Seattle Children's Hospital
Willing to participate in assessment and treatment
Have at least one parent/caregiver willing to participate in assessment and treatment
Exclusion Criteria:
Meet Diagnostic and Statistical Manual of Mental Disorders (DSM - V) criteria for a psychotic disorder or bipolar disorder
Active suicidality
Substance dependence
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederick P Rivara, MD, MPH
Organizational Affiliation
Seattle Childrens Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seattle Childrens Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
27624513
Citation
McCarty CA, Zatzick D, Stein E, Wang J, Hilt R, Rivara FP; Seattle Sports Concussion Research Collaborative. Collaborative Care for Adolescents With Persistent Postconcussive Symptoms: A Randomized Trial. Pediatrics. 2016 Oct;138(4):e20160459. doi: 10.1542/peds.2016-0459. Epub 2016 Sep 13.
Results Reference
derived
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Care for Post-Concussive Symptoms
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