An interventional study of Specialist and Pediatrician Co-Management for Early and Effective Concussion Care Delivery to Hasten Your Recovery (SPEEDY Recovery) in Concussion, sponsored by University of Rhode Island. Not yet recruiting at 1 site in United States. Open to participants aged 8 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-07-30.
Sponsored by University of Rhode Island · Not applicable, Interventional, and Treatment
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.
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.
637 studies on the registry are indexed under Brain Concussion; 163 are open to participants now.
This study's planned enrollment of 10 is below the median of 63 across 446 interventional studies indexed under Brain Concussion.
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Inclusion Criteria:
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).
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).
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.
Time frame: 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.
Time frame: 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.
Time frame: Final Study Visit (up to 4 weeks post injury)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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)
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.
Time frame: Initial Visit (within 5 days of injury) and Final Visit (up to 4 weeks post injury)
Plan to share: 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.
Supporting information: Analytic code
Time frame: beginning 12 months after publication
Access criteria: qualified investigators who submit a methodologically sound proposal and sign a data use agreement.
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University of Rhode Island