ConcussionSPEEDYRecoveryNCT07736534
Telehealth Specialty Concussion Treatment for Youth
A study testing Specialist and Pediatrician Co-Management for Early and Effective Concussion Care Delivery to Hasten Your Recovery (SPEEDY Recovery) in people with Concussion, run by University of Rhode Island at 1 site in United States.
Trial summary
Specialty concussion care can help youth recover more quickly but many youth face barriers to accessing concussion specialists. A care delivery model whereby concussion specialists are available to co-manage injuries with primary care pediatricians via telehealth can close the gap that currently exists in delivering… Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Concussion
- What is being tested?
- Specialist and Pediatrician Co-Management for Early and Effective Concussion Care Delivery to Hasten Your Recovery (SPEEDY Recovery)
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jul 2026to 15 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- youth aged 8 to 17
- At least one parent/caregiver present and willing to participate
- English proficiency
- access to an internet connected device,
- within 5 days of injury
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Hasbro Children's Hospital
Providence, Rhode Island, 02903
Alison Riese, M.D., MPH, 401-444-8531, ariese@brownhealth.org
About this study
Official title: Specialist and Pediatrician Co-Management for Early and Effective Concussion Care Delivery to Hasten Your Recovery (SPEEDY Recovery): A Pilot Study
Specialty concussion care can help youth recover more quickly but many youth face barriers to accessing concussion specialists. A care delivery model whereby concussion specialists are available to co-manage injuries with primary care pediatricians via telehealth can close the gap that currently exists in delivering specialty care to more youth. The long-term objective and intended impact of this project is to disseminate a care delivery model and manualized behavioral health intervention that can be widely deployed to make specialty concussion care accessible to more youth and earlier following their head injury.
Read the detailed description
Youth who receive specialty concussion care recover more quickly. Unfortunately, specialty concussion care is not accessible to all children and adolescents. Initial studies suggest that delivering specialty concussion care via telehealth is feasible and effective, however, available studies have been conducted in specialty clinics. As noted, there are barriers accessing specialty concussion clinics and furthermore youth with concussion most frequently initiate care with their primary care provider. The objective of this study is to pilot an innovative care delivery model whereby a concussion specialist provides telehealth-based consultations to co-manage concussions with primary care pediatricians. The care delivery model is a manualized intervention for the first four weeks following pediatric concussion, called Specialist and Pediatrician Co-Management for Early and Effective Concussion Care Delivery to Hasten Your Recovery or SPEEDY Recovery. The intervention includes: 1) behavioral symptom management strategies including recommendations for headaches, sleep difficulty, emotional health/stress reduction, and cognitive symptoms, individualized for each youth based on their symptoms, 2) guidance to support school reintegration following concussion (e.g., study strategies, symptom management strategies for school, documentation for time-limited accommodations to support recovery), and 3) guidance to return to sports (if relevant). The aims of this project are to pilot the feasibility, acceptability, and credibility of the SPEEDY RECOVERY program as well as to determine potential implementation barriers and examine patient, caregiver, and pediatrician perceptions of the program. A pilot trial will recruit 10 pediatric patients with recent concussion (presenting to their primary care provider within 5 days of injury) from an urban, hospital-based pediatric primary care clinic that serves predominantly under-resourced youth and families and that does not have an affiliated concussion specialist. The intervention will be delivered via once weekly telehealth visits with a concussion specialist (neuropsychologist) until youth are recovered (youth and caregivers report resolution of concussion-related symptoms and return to normal state of health) or up to 4 weeks post injury (at which point recovery will be deemed prolonged and youth will be referred to appropriate rehabilitation services). Exit interviews will be conducted with youth and their caregivers at the final visit. Additionally, pediatricians in the practice will be surveyed at the end of the study regarding successes and opportunities for improving the program as well as reasons why they referred or did not refer patients. The youth, caregiver, and provider feedback will inform improvements and refinements to the design and implementation details to maximize the relevance and benefits of the program. The long-term objective is to disseminate a care delivery model and manualized behavioral health intervention that can be widely deployed to make specialty concussion care accessible to more youth and earlier following their head injury.
- Conditions
- Concussion
- Being tested
- Specialist and Pediatrician Co-Management for Early and Effective Concussion Care Delivery to Hasten Your Recovery (SPEEDY Recovery)
- Keywords
- concussion, telehealth, access to care, children, adolescents
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specialist and Pediatrician Co-Management for Early and Effective Concussion Care Delivery to Hasten Your Recovery (SPEEDY Recovery)Behavioural
The SPEEDY Recovery program is a novel, concussion-specialist telehealth consultation and co-management intervention for the first 4 weeks post injury. The program involves a concussion specialist (clinical neuropsychologist) meeting with a youth and caregivers once per week via telehealth to provide: 1) behavioral health symptom management strategies including recommendations for headaches, sleep difficulty, emotional health/stress reduction, and cognitive symptoms, individualized for each youth based on their symptoms, 2) guidance to support school reintegration following concussion (e.g., study strategies, symptom management strategies for school, documentation for time-limited accommodations to support recovery), and 3) guidance to return to sports (if relevant). The intervention is designed to be delivered via HIPPA compliant Zoom, which allows participants to join the virtual meetings/sessions from any internet-connected device (e.g., computer, tablet, smartphone).
| Study group | Role | What they receive |
|---|---|---|
| Telehealth consultation | Experimental | The SPEEDY Recovery program is a novel, concussion-specialist telehealth consultation and co-management intervention for the first 4 weeks post injury. The program involves a concussion specialist (clinical neuropsychologist) meeting with a youth and caregivers once per week via telehealth to provide: 1) behavioral health symptom management strategies including recommendations for headaches, sleep difficulty, emotional health/stress reduction, and cognitive symptoms, individualized for each youth based on their symptoms, 2) guidance to support school reintegration following concussion (e.g., study strategies, symptom management strategies for school, documentation for time-limited accommodations to support recovery), and 3) guidance to return to sports (if relevant). The intervention is designed to be delivered via HIPPA compliant Zoom, which allows participants to join the virtual meetings/sessions from any internet-connected device (e.g., computer, tablet, smartphone). Receives: Behavioral: Specialist and Pediatrician Co-Management for Early and Effective Concussion Care Delivery to Hasten Your Recovery (SPEEDY Recovery) |
What is being measured
The primary outcome is the main question the study is designed to answer.
SCAT6 Symptom Questionnaire
The SCAT6 Symptom Evaluation(for youth 13 and older) is a self-report measure of the presence and severity of 22 symptoms associated with concussion. Scores can range from 0 to 132. Higher scores represent worse symptom severity.
Measured: Initial visit (within 5 days of injury), once per week through study completion (up to 4 weeks post injury)
ChildSCAT6 Symptom Questionnaire
The ChildSCAT6 Symptom Evaluation (for children ages 8 to 12) is a self-report measure of the presence and severity of 21 symptoms associated with concussion. Scores can range from 0 to 63. Higher scores represent worse symptom severity.
Measured: Initial visit (within 5 days of injury), once per week through study completion (up to 4 weeks post injury)
Credibility and Expectancy Questionnaire (CEQ)
The Credibility and Expectancy Questionnaire (CEQ) assesses how believable, convincing, and logical patients perceive the treatment to be. Scores can range from 6 to 54. Higher score represent greater confidence and higher optimism in the treatment.
Measured: Final Study Visit (up to 4 weeks post injury)
Secondary outcomes (5)
SCAT6 Cognitive Screening
The SCAT-6 Cognitive Screening (ages 13 and older) is a clinician-administered composed of 4 tasks: orientation, immediate memory, concentration, and delated memory. Scores can range from 0 to 50. Higher scores represent better cognitive functioning.
Measured: Initial Visit (within 5 days of injury) and Final Visit (up to 4 weeks post injury)
ChildSCAT6 Cognitive Screening
The ChildSCAT-6 Cognitive Screening (ages 8 to 12) is a clinician-administered composed of 4 tasks: orientation, immediate memory, concentration, and delated memory. Scores can range from 0 to 50. Higher scores represent better cognitive functioning.
Measured: Initial visit (within 5 days of injury) and Final Study Visit (up to 4 weeks post injury)
GAD-7
The GAD-7 is a 7-item questionnaire assessing anxiety symptoms within the past 2 weeks. Youth aged 11 and older will provide their self-report. For children ages 8 to 10, caregivers will complete this measure indicating how often their child has exhibited the symptoms. Scores can range from 0 to 21. Higher scores represent more/worse anxiety.
Measured: Initial Visit (within 5 days of injury) and Final Visit (up to 4 weeks post injury)
PHQ-9
The PHQ-9 is a 9-item questionnaire assessing depression symptoms within the past 2 weeks. Youth aged 12 and older will provide their self-report. For children ages 8 to 11, caregivers will complete this measure indicating how often their child has exhibited the symptoms. Score can range from 0 to 27. Higher scores represent more/worse depression.
Measured: Initial Visit (within 5 days of injury) and Final Visit (up to 4 weeks post injury)
Concussion Learning Assessment & School Survey, 3rd Edition (CLASS-3)
The Concussion Learning Assessment \& School Survey, 3rd Edition (CLASS-3) is a scale to assess and identify clinical problems and needs related to returning to school following concussion. There are self- and parent-report versions. Scores can range from 0 to 67. Higher scores represent greater levels of academic difficulty, distress, and impairment.
Measured: Initial Visit (within 5 days of injury) and Final Visit (up to 4 weeks post injury)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start18 Jul 2026 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion15 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rhode Island
- Sponsor type
- University, hospital or other
- Collaborators
- Hasbro Children's Hospital, Rhode Island Hospital, The Warren Alpert Medical School of Brown University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07736534
- Sponsor's protocol ID
- 2526-316
- Acronym
- SPEEDYRecovery
- Status last verified
- Jul 2026
- First submitted
- 20 Jul 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the published results will be available beginning 12 months after publication to qualified investigators who submit a methodologically sound proposal and sign a data use agreement.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Specialist and Pediatrician Co-Management for Early and Effective Concussion Care Delivery to Hasten Your Recovery (SPEEDY Recovery): A Pilot Study
- ClinicalTrials.gov ID
- NCT07736534
- Acronym / sponsor ID
- SPEEDYRecovery / 2526-316
- Conditions
- Concussion
- Keywords
- concussion, telehealth, access to care, children, adolescents
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of Rhode IslandUniversity, hospital or other
- Collaborators
- Hasbro Children's Hospital, Rhode Island Hospital, The Warren Alpert Medical School of Brown University
- Study start
- 18 Jul 2026 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 15 Jan 2027 (estimated)
- First posted
- 30 Jul 2026 (actual)
- 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.
Specialty concussion care can help youth recover more quickly but many youth face barriers to accessing concussion specialists. A care delivery model whereby concussion specialists are available to co-manage injuries with primary care pediatricians via telehealth can close the gap that currently exists in delivering specialty care to more youth. The long-term objective and intended impact of this project is to disseminate a care delivery model and manualized behavioral health intervention that can be widely deployed to make specialty concussion care accessible to more youth and earlier following their head injury.
Detailed description
Youth who receive specialty concussion care recover more quickly. Unfortunately, specialty concussion care is not accessible to all children and adolescents. Initial studies suggest that delivering specialty concussion care via telehealth is feasible and effective, however, available studies have been conducted in specialty clinics. As noted, there are barriers accessing specialty concussion clinics and furthermore youth with concussion most frequently initiate care with their primary care provider. The objective of this study is to pilot an innovative care delivery model whereby a concussion specialist provides telehealth-based consultations to co-manage concussions with primary care pediatricians. The care delivery model is a manualized intervention for the first four weeks following pediatric concussion, called Specialist and Pediatrician Co-Management for Early and Effective Concussion Care Delivery to Hasten Your Recovery or SPEEDY Recovery. The intervention includes: 1) behavioral symptom management strategies including recommendations for headaches, sleep difficulty, emotional health/stress reduction, and cognitive symptoms, individualized for each youth based on their symptoms, 2) guidance to support school reintegration following concussion (e.g., study strategies, symptom management strategies for school, documentation for time-limited accommodations to support recovery), and 3) guidance to return to sports (if relevant). The aims of this project are to pilot the feasibility, acceptability, and credibility of the SPEEDY RECOVERY program as well as to determine potential implementation barriers and examine patient, caregiver, and pediatrician perceptions of the program. A pilot trial will recruit 10 pediatric patients with recent concussion (presenting to their primary care provider within 5 days of injury) from an urban, hospital-based pediatric primary care clinic that serves predominantly under-resourced youth and families and that does not have an affiliated concussion specialist. The intervention will be delivered via once weekly telehealth visits with a concussion specialist (neuropsychologist) until youth are recovered (youth and caregivers report resolution of concussion-related symptoms and return to normal state of health) or up to 4 weeks post injury (at which point recovery will be deemed prolonged and youth will be referred to appropriate rehabilitation services). Exit interviews will be conducted with youth and their caregivers at the final visit. Additionally, pediatricians in the practice will be surveyed at the end of the study regarding successes and opportunities for improving the program as well as reasons why they referred or did not refer patients. The youth, caregiver, and provider feedback will inform improvements and refinements to the design and implementation details to maximize the relevance and benefits of the program. The long-term objective is to disseminate a care delivery model and manualized behavioral health intervention that can be widely deployed to make specialty concussion care accessible to more youth and earlier following their head injury.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Telehealth consultation | Experimental | Behavioral: Specialist and Pediatrician Co-Management for Early and Effective Concussion Care Delivery to Hasten Your Recovery (SPEEDY Recovery)The SPEEDY Recovery program is a novel, concussion-specialist telehealth consultation and co-management intervention for the first 4 weeks post injury. The program involves a concussion specialist (clinical neuropsychologist) meeting with a youth and caregivers once per week via telehealth to provide: 1) behavioral health symptom management strategies including recommendations for headaches, sleep difficulty, emotional health/stress reduction, and cognitive symptoms, individualized for each youth based on their symptoms, 2) guidance to support school reintegration following concussion (e.g., study strategies, symptom management strategies for school, documentation for time-limited accommodations to support recovery), and 3) guidance to return to sports (if relevant). The intervention is designed to be delivered via HIPPA compliant Zoom, which allows participants to join the virtual meetings/sessions from any internet-connected device (e.g., computer, tablet, smartphone). |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- youth aged 8 to 17
- At least one parent/caregiver present and willing to participate
- English proficiency
- access to an internet connected device,
- within 5 days of injury
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Specialist and Pediatrician Co-Management for Early and Effective Concussion Care Delivery to Hasten Your Recovery (SPEEDY Recovery)The SPEEDY Recovery program is a novel, concussion-specialist telehealth consultation and co-management intervention for the first 4 weeks post injury. The program involves a concussion specialist (clinical neuropsychologist) meeting with a youth and caregivers once per week via telehealth to provide: 1) behavioral health symptom management strategies including recommendations for headaches, sleep difficulty, emotional health/stress reduction, and cognitive symptoms, individualized for each youth based on their symptoms, 2) guidance to support school reintegration following concussion (e.g., study strategies, symptom management strategies for school, documentation for time-limited accommodations to support recovery), and 3) guidance to return to sports (if relevant). The intervention is designed to be delivered via HIPPA compliant Zoom, which allows participants to join the virtual meetings/sessions from any internet-connected device (e.g., computer, tablet, smartphone). | Behavioural | Telehealth consultation |
Primary outcome
SCAT6 Symptom Questionnaire
Time frame: Initial visit (within 5 days of injury), once per week through study completion (up to 4 weeks post injury)
The SCAT6 Symptom Evaluation(for youth 13 and older) is a self-report measure of the presence and severity of 22 symptoms associated with concussion. Scores can range from 0 to 132. Higher scores represent worse symptom severity.
ChildSCAT6 Symptom Questionnaire
Time frame: Initial visit (within 5 days of injury), once per week through study completion (up to 4 weeks post injury)
The ChildSCAT6 Symptom Evaluation (for children ages 8 to 12) is a self-report measure of the presence and severity of 21 symptoms associated with concussion. Scores can range from 0 to 63. Higher scores represent worse symptom severity.
Credibility and Expectancy Questionnaire (CEQ)
Time frame: Final Study Visit (up to 4 weeks post injury)
The Credibility and Expectancy Questionnaire (CEQ) assesses how believable, convincing, and logical patients perceive the treatment to be. Scores can range from 6 to 54. Higher score represent greater confidence and higher optimism in the treatment.
5 secondary outcomes
SCAT6 Cognitive Screening
Time frame: Initial Visit (within 5 days of injury) and Final Visit (up to 4 weeks post injury)
ChildSCAT6 Cognitive Screening
Time frame: Initial visit (within 5 days of injury) and Final Study Visit (up to 4 weeks post injury)
GAD-7
Time frame: Initial Visit (within 5 days of injury) and Final Visit (up to 4 weeks post injury)
PHQ-9
Time frame: Initial Visit (within 5 days of injury) and Final Visit (up to 4 weeks post injury)
Concussion Learning Assessment & School Survey, 3rd Edition (CLASS-3)
Time frame: Initial Visit (within 5 days of injury) and Final Visit (up to 4 weeks post injury)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the published results will be available beginning 12 months after publication to qualified investigators who submit a methodologically sound proposal and sign a data use agreement.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Specialist and Pediatrician Co-Management for Early and Effective Concussion Care Delivery to Hasten Your Recovery (SPEEDY Recovery) in people with Concussion, run by University of Rhode Island 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 5 inclusion and 0 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: opening soon, as of the sponsor's last update on 30 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nathan Cook, Ph.D. (401-874-2665, nathan.cook@uri.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SCAT6 Symptom Questionnaire (time frame: Initial visit (within 5 days of injury), once per week through study completion (up to 4 weeks post injury)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.