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Care for Post-Concussive Symptoms (CARE4PCS)

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ClinicalTrials.gov Identifier: NCT02268240
Recruitment Status : Completed
First Posted : October 20, 2014
Last Update Posted : January 14, 2016
Sponsor:
Collaborator:
University of Washington
Information provided by (Responsible Party):
Fred Rivara, Seattle Children's Hospital

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.

Condition or disease Intervention/treatment
Concussion Behavioral: Stepped Care

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Care for Post-Concussive Symptoms
Study Start Date : October 2014
Primary Completion Date : January 2016
Study Completion Date : January 2016

Arm Intervention/treatment
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.
No Intervention: Control
Usual Care



Primary Outcome Measures :
  1. Change in Concussion Symptoms [ Time Frame: At enrollment, 1 month, 3 months, and 6 months ]
    Health Behavior Inventory Assessment

  2. Change in Depressive Symptoms [ Time Frame: At enrollment, 1 month, 3 months, and 6 months ]
    PHQ-9

  3. Change in Anxiety Symptoms [ Time Frame: At enrollment, 1 month, 3 months, and 6 months ]
    PROMIS A-8

  4. Change in Quality of Life [ Time Frame: At enrollment, 1 month, 3 months, and 6 months ]
    PedsQL


Secondary Outcome Measures :
  1. Change in School Functioning [ Time Frame: At enrollment, 1 month, 3 months, and 6 months ]
    Attendance and Grades

  2. Change in Family Functioning [ Time Frame: At enrollment, 1 month, 3 months, and 6 months ]
    FAD-GF

  3. Change in Parent Anxiety Symptoms [ Time Frame: At enrollment, 1 month, 3 months, and 6 months ]
    PROMIS A-8

  4. Change in Parent Depressive Symptoms [ Time Frame: At enrollment, 1 month, 3 months, and 6 months ]
    PHQ-9

  5. Change in ImPACT Assessment [ Time Frame: At enrollment and 6 months ]
    ImPACT test scores

  6. NIH Toolbox - Dimensional Card Sort Test [ Time Frame: At enrollment and 6 months ]
    Dimensional Card Sort Test scores

  7. Change in NIH Toolbox - Picture Memory Sequence Test [ Time Frame: At enrollment and 6 months ]
    Picture Memory Sequence test scores

  8. Change in King-Devick Test [ Time Frame: at enrollment and 6 months ]
    King-Devick Test scores



Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02268240


Locations
United States, Washington
Seattle Childrens Hospital
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Seattle Children's Hospital
University of Washington
Investigators
Principal Investigator: Frederick P Rivara, MD, MPH Seattle Childrens Hospital

Responsible Party: Fred Rivara, Seattle Children's Guild Endowed Chair in Pediatrics, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT02268240     History of Changes
Other Study ID Numbers: RS_CARE4PCS
First Posted: October 20, 2014    Key Record Dates
Last Update Posted: January 14, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
Post-Concussion Syndrome
Brain Concussion
Head Injuries, Closed
Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases
Wounds and Injuries
Wounds, Nonpenetrating