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Completed

NCT Number: NCT02268240

Care for Post-Concussive Symptoms

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.

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Key information

Age range

11 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seattle Childrens Hospital

Seattle, Washington, 98105, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stepped Care

Behavioral

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Seattle Children's Hospital

Other

Collaborators

  • University of Washington

Registry information

Acronym: CARE4PCS

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Oct 20, 2014
Registry last updated
Sep 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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