Care for Post-Concussive Symptoms (CARE4PCS)

September 16, 2018 updated by: Fred Rivara, Seattle Children's Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98105
        • Seattle Childrens Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Usual Care
Experimental: Experimental
Stepped Care
Behavioral: Stepped Care
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Concussion Symptoms
Time Frame: At enrollment, 1 month, 3 months, and 6 months
Health Behavior Inventory Assessment
At enrollment, 1 month, 3 months, and 6 months
Change in Depressive Symptoms
Time Frame: At enrollment, 1 month, 3 months, and 6 months
PHQ-9
At enrollment, 1 month, 3 months, and 6 months
Change in Anxiety Symptoms
Time Frame: At enrollment, 1 month, 3 months, and 6 months
PROMIS A-8
At enrollment, 1 month, 3 months, and 6 months
Change in Quality of Life
Time Frame: At enrollment, 1 month, 3 months, and 6 months
PedsQL
At enrollment, 1 month, 3 months, and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in School Functioning
Time Frame: At enrollment, 1 month, 3 months, and 6 months
Attendance and Grades
At enrollment, 1 month, 3 months, and 6 months
Change in Family Functioning
Time Frame: At enrollment, 1 month, 3 months, and 6 months
FAD-GF
At enrollment, 1 month, 3 months, and 6 months
Change in Parent Anxiety Symptoms
Time Frame: At enrollment, 1 month, 3 months, and 6 months
PROMIS A-8
At enrollment, 1 month, 3 months, and 6 months
Change in Parent Depressive Symptoms
Time Frame: At enrollment, 1 month, 3 months, and 6 months
PHQ-9
At enrollment, 1 month, 3 months, and 6 months
Change in ImPACT Assessment
Time Frame: At enrollment and 6 months
ImPACT test scores
At enrollment and 6 months
NIH Toolbox - Dimensional Card Sort Test
Time Frame: At enrollment and 6 months
Dimensional Card Sort Test scores
At enrollment and 6 months
Change in NIH Toolbox - Picture Memory Sequence Test
Time Frame: At enrollment and 6 months
Picture Memory Sequence test scores
At enrollment and 6 months
Change in King-Devick Test
Time Frame: at enrollment and 6 months
King-Devick Test scores
at enrollment and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seattle Children's Hospital

Collaborators

University of Washington

Investigators

  • Principal Investigator: Frederick P Rivara, MD, MPH, Seattle Childrens Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

October 10, 2014

First Submitted That Met QC Criteria

October 15, 2014

First Posted (Estimate)

October 20, 2014

Study Record Updates

Last Update Posted (Actual)

September 18, 2018

Last Update Submitted That Met QC Criteria

September 16, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RS_CARE4PCS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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