Concussion, BrainNCT03034720
Collaborative Care Model for the Treatment of Persistent Symptoms After Concussion Among Youth
A study testing Collaborative Care in people with Concussion, Brain and TBI, run by Seattle Children's Hospital at 1 site in United States.
Trial summary
SPECIFIC AIMS While post-concussive symptoms following sports-related concussion are typically transient and resolve spontaneously within two weeks of concussive injury, 14% or more of youth who sustain concussion experience significant morbidity that can persist well beyond the normal disease course.Furthermore… Read more about this study
- Who is it for?
- Ages 11 to 18 years
- Conditions the study is for
- Concussion, Brain, TBI, Depression
- What is being tested?
- Collaborative Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2017to 29 May 2020
- 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
- English speaking male and female sports-injured adolescents
- ages 11-18
- health care provider diagnosed concussion and with ≥ 3 HBI symptoms that have endured or worsened for at least 1-month but less than 9 months since injury will be included in the investigation.
Who cannot join
- Adolescents who require immediate intervention (e.g., acute suicidal ideation) will be excluded.
- Adolescents whose parents report that their child has ever had a diagnosis of schizophrenia or psychosis will be excluded from the study.
- Adolescents whose parents report concerns about their child's ability to communicate may be excluded from the study (pending consult with PIs).
- Adolescents who have suffered spinal cord or other severe injuries that prevent participation will be excluded from the study.
- Adults unable to consent are not included in this research
- Adolescents and parents who do not read and speak English will not be included
Show all 9Show fewer
- Wards of the state are not included in this research
- Pregnant women are not included in this research
- Prisoners are not included in this research
Trial locations and contacts
1 site in 1 country.
United States1 site
Seattle Childrens Hospital
Seattle, Washington, 98105
About this study
SPECIFIC AIMS
While post-concussive symptoms following sports-related concussion are typically transient and resolve spontaneously within two weeks of concussive injury, 14% or more of youth who sustain concussion experience significant morbidity that can persist well beyond the normal disease course.Furthermore, post-concussive symptoms commonly co-occur with affective symptoms including depression and anxiety which when present can prolong recovery from primary post-concussive symptoms. Together, persistent physical and psychological symptoms confer protracted functional impairment and create a significant burden for affected youth, their family, and school. Currently, there are no evidence-based guidelines to inform treatment of persistent post-concussive symptoms in youth and adolescents.
In response to the dearth of evidence-based treatment approaches for youth with persistent post-concussive symptoms, the investigators developed a novel collaborative care treatment model that simultaneously targets post-concussive symptoms and co-occurring depression and anxiety. Athletes and their family members receive patient navigator care management services that bridge post-injury care across acute care, specialist and primary care health service delivery sectors, in addition to cognitive behavioral psychotherapy. Patients who remain symptomatic after initial treatment efforts receive stepped-up care that may include psychopharmacologic consultation. The Investigators have demonstrated feasibility of the intervention model through a pilot randomized-control trial of 49 adolescents with persistent post-concussive symptoms recruited from a regional children's hospital. Participants assigned to the intervention condition demonstrated significant and clinically-meaningful reductions in post-concussive and depressive symptoms as well as health-related quality of life as compared to adolescents in the usual care arm of the trial.
Read the detailed description
The proposed study will expand upon the pilot trial in order to further develop, implement, and test the impact of an innovative collaborative care approach tailored to the needs of a patient population who currently have no evidence-based options. The investigators propose a broad reach intervention strategy that is designed to be readily implemented in acute, specialty and primary care medical settings, as well as over the telephone. The investigators will conduct a randomized comparative effectiveness trial with 200 youth, ages 11-18, suffering from ≥ 3 post-concussive symptoms at least 1 month after their sports-related injury. Athletes will be randomized to collaborative care (intervention) or post-sports injury care as usual (control group) conditions. The study is designed with the following aims:
Aim 1. To determine the effectiveness of a stepped-collaborative care intervention model in reducing post-concussive and co-occurring psychological symptoms in youth with persistent post-concussive symptoms after sports-related concussion H1: Youth receiving a collaborative care intervention will demonstrate clinically and statistically significant reductions in post-concussive symptoms, depressive and anxiety symptoms over the course of the 12-month study, compared to usual care control group athletes Aim 2. To examine the effectiveness of the intervention in improving function and health-related quality of life amongst youth with persistent symptoms after sports-related concussion H2: Adolescents who receive a collaborative care intervention will exhibit a clinically meaningful improvement in function and health-related quality life Exploratory Aim 3. To explore differences in school performance between groups H3: Adolescents who receive the collaborative care intervention will receive individualized treatment and community resource linkages which will improve their school performance as compared to adolescents receiving treatment as usual Aim 4. To explore the heterogeneity of treatment effects in the primary and secondary outcomes by examining the interaction of the treatment effect with group membership in distinct subgroups of the population. H4: Three distinct subgroups are expected to emerge from the study population: adolescents who recover from symptoms, adolescents with chronic psychosocial problems, and adolescents whose symptoms wax and wane over time. A greater proportion of adolescents who recover from symptoms will emerge in the treatment group, compared to controls.
IMPACT: By broadly targeting the constellation of post-concussive physical and psychological symptoms and integrating care amongst primary care, pediatric sub-specialist, and behavioral health providers, the collaborative care health services intervention could accelerate the rate of recovery from persistent post-concussive symptoms and attenuate the degree and duration of disability during adolescence, a critical period for healthy development. Validation of this treatment through a scaled up clinical trial will serve as a foundation for broader dissemination of this collaborative care treatment model. The multidisciplinary sports concussion research team will simultaneously work nationally and internationally to ensure study results are expediently translated into effective policy for youth athletes suffering from enduring symptoms and functional impairments in the wake of sports-related concussions.
- Conditions
- Concussion, Brain, TBI, Depression, Anxiety
- Being tested
- Collaborative Care
- Keywords
- Concussion, persistent post-concussive symptoms, CBT, collaborative care, Depression, Anxiety
- Medical subject headings
- Brain Concussion, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collaborative CareBehavioural
Intervention subjects will receive treatment from an MSW-trained care manager over the course of 6-months after randomization. Intervention team members will work collaboratively with primary care providers to link physical and mental health care longitudinally through outpatient follow-up and community rehabilitation. Intervention subjects and their families and collaborative team members will share information and deliberate treatment decisions with each other in order to develop an individually tailored treatment plan. Stepped, higher intensity care will be available for intervention subjects with recurrent symptoms. Stepped up care will include CBT booster sessions targeting post-concussive and related symptom comorbidity as well as psychopharmacologic assessment and treatment.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Intervention subjects will receive treatment from an MSW-trained care manager over the course of 6-months after randomization. Intervention team members will work collaboratively with primary care providers to link physical and mental health care longitudinally through outpatient follow-up and community rehabilitation. Intervention subjects and their families and collaborative team members will share information and deliberate treatment decisions with each other in order to develop an individually tailored treatment plan. Stepped, higher intensity care will be available for intervention subjects with recurrent symptoms. Stepped up care will include CBT booster sessions targeting post-concussive and related symptom comorbidity as well as psychopharmacologic assessment and treatment. Receives: Behavioral: Collaborative Care |
| Control | No intervention | Adolescent subjects in the control group will receive care as usual from their health care providers, a standard that is ethically acceptable. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-concussive symptoms measured with the HBI
The central hypothesis is that the two groups will have different patterns of HBI scores over time, with the intervention group showing significant. reductions when compared to controls.
Measured: During the12 months after enrollment.
Health related quality of life as measured with the PedsQL
The hypothesis is that the two groups will have different patterns of PEDSQL scores over time, with the intervention group showing significant reductions when compared to controls.
Measured: During the 12 months after enrollment
Depressive symptoms measured by the PHQ-9
The hypothesis is that the two groups will have different patterns of PHQ-9 scores over time, with the intervention group showing significant. reductions when compared to controls.
Measured: During the12 months after enrollment.
Anxiety symptoms measured by the GAD-7
The hypothesis is that the two groups will have different patterns of GAD-7 scores over time, with the intervention group showing significant reductions when compared to controls.
Measured: During the 12 months after enrollment
Anxiety symptoms measured by the RCADS
The hypothesis is that the two groups will have different patterns of RCADS scores over time, with the intervention group showing significant reductions when compared to controls.
Measured: During the 12 months after enrollment
Secondary outcomes (2)
School performance as measured by GPA
Measured: During the 12 months after enrollment
Return to full activities at school as measured by the CLASS
The secondary hypothesis is that the two groups will have different patterns on the CLASS over time, with the intervention group showing significant reductions when compared to controls
Measured: During the 12 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2017 (estimated)
- Study start9 Mar 2017
- Primary completion29 May 2020
- Study completion29 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Concussion, BrainStudies of the same condition, open and under way.
- More trials run by Seattle Children's HospitalThe sponsor's other registered studies.
- 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fred Rivara, Seattle Children's Hospital
- Investigators
- Frederick P Rivara, MD, Principal investigator, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03034720
- Sponsor's protocol ID
- STUDY00000437
- Status last verified
- Apr 2021
- First submitted
- 11 Jan 2017
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Payne KM, Prentice ET, Marcynyszyn LA, McCarty CA. Goals for Persistent Postconcussive Symptom Treatment From Adolescent and Parent Perspectives. JAMA Pediatr. 2020 Dec 1;174(12):1210-1211. doi: 10.1001/jamapediatrics.2020.0898.
PubMed 32391873Marcynyszyn LA, McCarty CA, Rivara FP, Johnson AM, Wang J, Zatzick DF. Parent Traumatic Events and Adolescent Internalizing Symptoms: The Mediating Role of Parental Depression Among Youth with Persistent Post-concussive Symptoms. J Pediatr Psychol. 2021 Jun 3;46(5):547-556. doi: 10.1093/jpepsy/jsaa128.
PubMed 33411915McCarty CA, Zatzick D, Hoopes T, Payne K, Parrish R, Rivara FP. Collaborative care model for treatment of persistent symptoms after concussion among youth (CARE4PCS-II): Study protocol for a randomized, controlled trial. Trials. 2019 Sep 18;20(1):567. doi: 10.1186/s13063-019-3662-3.
PubMed 31533799Johnson AM, McCarty CA, Marcynyszyn LA, Zatzick DF, Chrisman SP, Rivara FP. Child- compared with parent-report ratings on psychosocial measures following a mild traumatic brain injury among youth with persistent post-concussion symptoms. Brain Inj. 2021 Apr 16;35(5):574-586. doi: 10.1080/02699052.2021.1889663. Epub 2021 Mar 18.
PubMed 33733955McCarty CA, Zatzick DF, Marcynyszyn LA, Wang J, Hilt R, Jinguji T, Quitiquit C, Chrisman SPD, Rivara FP. Effect of Collaborative Care on Persistent Postconcussive Symptoms in Adolescents: A Randomized Clinical Trial. JAMA Netw Open. 2021 Feb 1;4(2):e210207. doi: 10.1001/jamanetworkopen.2021.0207.
PubMed 33635325Marcynyszyn LA, McCarty CA, Chrisman SPD, Zatzick DF, Johnson AM, Wang J, Hilt RJ, Rivara FP. Psychometric Properties and Validation of the General Anxiety Disorder 7-Item Scale Among Adolescents With Persistent Post-Concussive Symptoms. Neurotrauma Rep. 2023 Apr 27;4(1):276-283. doi: 10.1089/neur.2022.0075. eCollection 2023.
PubMed 37139182
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collaborative Care Model for the Treatment of Persistent Symptoms After Concussion Among Youth
- ClinicalTrials.gov ID
- NCT03034720
- Acronym / sponsor ID
- STUDY00000437
- Conditions
- Concussion, Brain, TBI, Depression, Anxiety
- Keywords
- Concussion, persistent post-concussive symptoms, CBT, collaborative care, Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Study start
- 9 Mar 2017 (actual)
- Primary completion
- 29 May 2020 (actual)
- Study completion
- 29 May 2020 (actual)
- First posted
- 27 Jan 2017 (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.
SPECIFIC AIMS
While post-concussive symptoms following sports-related concussion are typically transient and resolve spontaneously within two weeks of concussive injury, 14% or more of youth who sustain concussion experience significant morbidity that can persist well beyond the normal disease course.Furthermore, post-concussive symptoms commonly co-occur with affective symptoms including depression and anxiety which when present can prolong recovery from primary post-concussive symptoms. Together, persistent physical and psychological symptoms confer protracted functional impairment and create a significant burden for affected youth, their family, and school. Currently, there are no evidence-based guidelines to inform treatment of persistent post-concussive symptoms in youth and adolescents.
In response to the dearth of evidence-based treatment approaches for youth with persistent post-concussive symptoms, the investigators developed a novel collaborative care treatment model that simultaneously targets post-concussive symptoms and co-occurring depression and anxiety. Athletes and their family members receive patient navigator care management services that bridge post-injury care across acute care, specialist and primary care health service delivery sectors, in addition to cognitive behavioral psychotherapy. Patients who remain symptomatic after initial treatment efforts receive stepped-up care that may include psychopharmacologic consultation. The Investigators have demonstrated feasibility of the intervention model through a pilot randomized-control trial of 49 adolescents with persistent post-concussive symptoms recruited from a regional children's hospital. Participants assigned to the intervention condition demonstrated significant and clinically-meaningful reductions in post-concussive and depressive symptoms as well as health-related quality of life as compared to adolescents in the usual care arm of the trial.
Detailed description
The proposed study will expand upon the pilot trial in order to further develop, implement, and test the impact of an innovative collaborative care approach tailored to the needs of a patient population who currently have no evidence-based options. The investigators propose a broad reach intervention strategy that is designed to be readily implemented in acute, specialty and primary care medical settings, as well as over the telephone. The investigators will conduct a randomized comparative effectiveness trial with 200 youth, ages 11-18, suffering from ≥ 3 post-concussive symptoms at least 1 month after their sports-related injury. Athletes will be randomized to collaborative care (intervention) or post-sports injury care as usual (control group) conditions. The study is designed with the following aims:
Aim 1. To determine the effectiveness of a stepped-collaborative care intervention model in reducing post-concussive and co-occurring psychological symptoms in youth with persistent post-concussive symptoms after sports-related concussion H1: Youth receiving a collaborative care intervention will demonstrate clinically and statistically significant reductions in post-concussive symptoms, depressive and anxiety symptoms over the course of the 12-month study, compared to usual care control group athletes Aim 2. To examine the effectiveness of the intervention in improving function and health-related quality of life amongst youth with persistent symptoms after sports-related concussion H2: Adolescents who receive a collaborative care intervention will exhibit a clinically meaningful improvement in function and health-related quality life Exploratory Aim 3. To explore differences in school performance between groups H3: Adolescents who receive the collaborative care intervention will receive individualized treatment and community resource linkages which will improve their school performance as compared to adolescents receiving treatment as usual Aim 4. To explore the heterogeneity of treatment effects in the primary and secondary outcomes by examining the interaction of the treatment effect with group membership in distinct subgroups of the population. H4: Three distinct subgroups are expected to emerge from the study population: adolescents who recover from symptoms, adolescents with chronic psychosocial problems, and adolescents whose symptoms wax and wane over time. A greater proportion of adolescents who recover from symptoms will emerge in the treatment group, compared to controls.
IMPACT: By broadly targeting the constellation of post-concussive physical and psychological symptoms and integrating care amongst primary care, pediatric sub-specialist, and behavioral health providers, the collaborative care health services intervention could accelerate the rate of recovery from persistent post-concussive symptoms and attenuate the degree and duration of disability during adolescence, a critical period for healthy development. Validation of this treatment through a scaled up clinical trial will serve as a foundation for broader dissemination of this collaborative care treatment model. The multidisciplinary sports concussion research team will simultaneously work nationally and internationally to ensure study results are expediently translated into effective policy for youth athletes suffering from enduring symptoms and functional impairments in the wake of sports-related concussions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Collaborative CareIntervention subjects will receive treatment from an MSW-trained care manager over the course of 6-months after randomization. Intervention team members will work collaboratively with primary care providers to link physical and mental health care longitudinally through outpatient follow-up and community rehabilitation. Intervention subjects and their families and collaborative team members will share information and deliberate treatment decisions with each other in order to develop an individually tailored treatment plan. Stepped, higher intensity care will be available for intervention subjects with recurrent symptoms. Stepped up care will include CBT booster sessions targeting post-concussive and related symptom comorbidity as well as psychopharmacologic assessment and treatment. |
| Control | No intervention | –Adolescent subjects in the control group will receive care as usual from their health care providers, a standard that is ethically acceptable. |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- English speaking male and female sports-injured adolescents
- ages 11-18
- health care provider diagnosed concussion and with ≥ 3 HBI symptoms that have endured or worsened for at least 1-month but less than 9 months since injury will be included in the investigation.
Key exclusion criteria (9 listed)
- Adolescents who require immediate intervention (e.g., acute suicidal ideation) will be excluded.
- Adolescents whose parents report that their child has ever had a diagnosis of schizophrenia or psychosis will be excluded from the study.
- Adolescents whose parents report concerns about their child's ability to communicate may be excluded from the study (pending consult with PIs).
- Adolescents who have suffered spinal cord or other severe injuries that prevent participation will be excluded from the study.
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 |
|---|---|---|
| Collaborative CareIntervention subjects will receive treatment from an MSW-trained care manager over the course of 6-months after randomization. Intervention team members will work collaboratively with primary care providers to link physical and mental health care longitudinally through outpatient follow-up and community rehabilitation. Intervention subjects and their families and collaborative team members will share information and deliberate treatment decisions with each other in order to develop an individually tailored treatment plan. Stepped, higher intensity care will be available for intervention subjects with recurrent symptoms. Stepped up care will include CBT booster sessions targeting post-concussive and related symptom comorbidity as well as psychopharmacologic assessment and treatment. | Behavioural | Intervention |
Primary outcome
Post-concussive symptoms measured with the HBI
Time frame: During the12 months after enrollment.
The central hypothesis is that the two groups will have different patterns of HBI scores over time, with the intervention group showing significant. reductions when compared to controls.
Health related quality of life as measured with the PedsQL
Time frame: During the 12 months after enrollment
The hypothesis is that the two groups will have different patterns of PEDSQL scores over time, with the intervention group showing significant reductions when compared to controls.
Depressive symptoms measured by the PHQ-9
Time frame: During the12 months after enrollment.
The hypothesis is that the two groups will have different patterns of PHQ-9 scores over time, with the intervention group showing significant. reductions when compared to controls.
Anxiety symptoms measured by the GAD-7
Time frame: During the 12 months after enrollment
The hypothesis is that the two groups will have different patterns of GAD-7 scores over time, with the intervention group showing significant reductions when compared to controls.
Anxiety symptoms measured by the RCADS
Time frame: During the 12 months after enrollment
The hypothesis is that the two groups will have different patterns of RCADS scores over time, with the intervention group showing significant reductions when compared to controls.
2 secondary outcomes
School performance as measured by GPA
Time frame: During the 12 months after enrollment
Return to full activities at school as measured by the CLASS
Time frame: During the 12 months after enrollment
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 8 Apr 2021.
- Background: PubMed 32391873Payne KM, Prentice ET, Marcynyszyn LA, McCarty CA. Goals for Persistent Postconcussive Symptom Treatment From Adolescent and Parent Perspectives. JAMA Pediatr. 2020 Dec 1;174(12):1210-1211. doi: 10.1001/jamapediatrics.2020.0898.
- Background: PubMed 33411915Marcynyszyn LA, McCarty CA, Rivara FP, Johnson AM, Wang J, Zatzick DF. Parent Traumatic Events and Adolescent Internalizing Symptoms: The Mediating Role of Parental Depression Among Youth with Persistent Post-concussive Symptoms. J Pediatr Psychol. 2021 Jun 3;46(5):547-556. doi: 10.1093/jpepsy/jsaa128.
- Background: PubMed 31533799McCarty CA, Zatzick D, Hoopes T, Payne K, Parrish R, Rivara FP. Collaborative care model for treatment of persistent symptoms after concussion among youth (CARE4PCS-II): Study protocol for a randomized, controlled trial. Trials. 2019 Sep 18;20(1):567. doi: 10.1186/s13063-019-3662-3.
- Background: PubMed 33733955Johnson AM, McCarty CA, Marcynyszyn LA, Zatzick DF, Chrisman SP, Rivara FP. Child- compared with parent-report ratings on psychosocial measures following a mild traumatic brain injury among youth with persistent post-concussion symptoms. Brain Inj. 2021 Apr 16;35(5):574-586. doi: 10.1080/02699052.2021.1889663. Epub 2021 Mar 18.
- Results publication: PubMed 33635325McCarty CA, Zatzick DF, Marcynyszyn LA, Wang J, Hilt R, Jinguji T, Quitiquit C, Chrisman SPD, Rivara FP. Effect of Collaborative Care on Persistent Postconcussive Symptoms in Adolescents: A Randomized Clinical Trial. JAMA Netw Open. 2021 Feb 1;4(2):e210207. doi: 10.1001/jamanetworkopen.2021.0207.
- Derived from this study: PubMed 37139182Marcynyszyn LA, McCarty CA, Chrisman SPD, Zatzick DF, Johnson AM, Wang J, Hilt RJ, Rivara FP. Psychometric Properties and Validation of the General Anxiety Disorder 7-Item Scale Among Adolescents With Persistent Post-Concussive Symptoms. Neurotrauma Rep. 2023 Apr 27;4(1):276-283. doi: 10.1089/neur.2022.0075. eCollection 2023.
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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 principal investigator
Seattle Children's 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 Collaborative Care in people with Concussion, Brain and TBI, 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 3 inclusion and 9 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 8 Apr 2021. 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?
Post-concussive symptoms measured with the HBI (time frame: During the12 months after enrollment.). The study lists 5 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 NCT03034720, which also lists 6 linked publications.
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 8 Apr 2021.