ConcussionCARE4PCSNCT02268240
Care for Post-Concussive Symptoms
A study testing Stepped Care in people with Concussion, run by Seattle Children's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 18 years
- Conditions the study is for
- Concussion
- What is being tested?
- Stepped Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Jan 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 11 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Meet Diagnostic and Statistical Manual of Mental Disorders (DSM - V) criteria for a psychotic disorder or bipolar disorder
- Active suicidality
- Substance dependence
Trial locations and contacts
1 site in 1 country.
United States1 site
Seattle Childrens Hospital
Seattle, Washington, 98105
About this study
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.
- Conditions
- Concussion
- Being tested
- Stepped Care
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stepped CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Stepped Care Receives: Behavioral: Stepped Care |
| Control | No intervention | Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Concussion Symptoms
Health Behavior Inventory Assessment
Measured: At enrollment, 1 month, 3 months, and 6 months
Change in Depressive Symptoms
PHQ-9
Measured: At enrollment, 1 month, 3 months, and 6 months
Change in Anxiety Symptoms
PROMIS A-8
Measured: At enrollment, 1 month, 3 months, and 6 months
Change in Quality of Life
PedsQL
Measured: At enrollment, 1 month, 3 months, and 6 months
Secondary outcomes (8)
Change in School Functioning
Attendance and Grades
Measured: At enrollment, 1 month, 3 months, and 6 months
Change in Family Functioning
FAD-GF
Measured: At enrollment, 1 month, 3 months, and 6 months
Change in Parent Anxiety Symptoms
PROMIS A-8
Measured: At enrollment, 1 month, 3 months, and 6 months
Change in Parent Depressive Symptoms
PHQ-9
Measured: At enrollment, 1 month, 3 months, and 6 months
Change in ImPACT Assessment
ImPACT test scores
Measured: At enrollment and 6 months
NIH Toolbox - Dimensional Card Sort Test
Dimensional Card Sort Test scores
Measured: At enrollment and 6 months
Change in NIH Toolbox - Picture Memory Sequence Test
Picture Memory Sequence test scores
Measured: At enrollment and 6 months
Change in King-Devick Test
King-Devick Test scores
Measured: at enrollment and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ConcussionStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington
- Responsible party
- Principal investigator, Fred Rivara, Seattle Children's Hospital
- Investigators
- Frederick P Rivara, MD, MPH, Principal investigator, Seattle Childrens Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02268240
- Sponsor's protocol ID
- RS_CARE4PCS
- Acronym
- CARE4PCS
- Status last verified
- Sep 2018
- First submitted
- 10 Oct 2014
- Last updated
- 18 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27624513
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Care for Post-Concussive Symptoms
- ClinicalTrials.gov ID
- NCT02268240
- Acronym / sponsor ID
- CARE4PCS / RS_CARE4PCS
- Conditions
- Concussion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Collaborators
- University of Washington
- Study start
- Oct 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 20 Oct 2014 (estimated)
- 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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Stepped CareStepped Care |
| Control | No intervention | –Usual Care |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- Meet Diagnostic and Statistical Manual of Mental Disorders (DSM - V) criteria for a psychotic disorder or bipolar disorder
- Active suicidality
- Substance dependence
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 |
|---|---|---|
| Stepped CareIntervention 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. | Behavioural | Experimental |
Primary outcome
Change in Concussion Symptoms
Time frame: At enrollment, 1 month, 3 months, and 6 months
Health Behavior Inventory Assessment
Change in Depressive Symptoms
Time frame: At enrollment, 1 month, 3 months, and 6 months
PHQ-9
Change in Anxiety Symptoms
Time frame: At enrollment, 1 month, 3 months, and 6 months
PROMIS A-8
Change in Quality of Life
Time frame: At enrollment, 1 month, 3 months, and 6 months
PedsQL
8 secondary outcomes
Change in School Functioning
Time frame: At enrollment, 1 month, 3 months, and 6 months
Change in Family Functioning
Time frame: 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
Change in Parent Depressive Symptoms
Time frame: At enrollment, 1 month, 3 months, and 6 months
Change in ImPACT Assessment
Time frame: At enrollment and 6 months
NIH Toolbox - Dimensional Card Sort Test
Time frame: At enrollment and 6 months
Change in NIH Toolbox - Picture Memory Sequence Test
Time frame: At enrollment and 6 months
Change in King-Devick Test
Time frame: at enrollment and 6 months
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 18 Sep 2018.
- Derived from this study: PubMed 27624513McCarty 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.
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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.
Frederick P Rivara, MD, MPH principal investigator
Seattle Childrens Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stepped Care in people with Concussion, run by Seattle Children's Hospital at 1 site in United States.
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 8 inclusion and 3 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 18 Sep 2018. 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 United States. 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 Concussion Symptoms (time frame: At enrollment, 1 month, 3 months, and 6 months). The study lists 4 primary outcomes in all. 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 NCT02268240, which also lists 1 linked publication.
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 18 Sep 2018.