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NCT Number: NCT07736534

Telehealth Specialty Concussion Treatment for Youth

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.

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Key information

Age range

8 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hasbro Children's Hospital

Providence, Rhode Island, 02903, United States

Location contact

Alison Riese, M.D., MPH

CONTACT

[email protected]

401-444-8531

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Treatment and study plan

Specialist and Pediatrician Co-Management for Early and Effective Concussion Care Delivery to Hasten Your Recovery (SPEEDY Recovery)

Behavioral

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).

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. SCAT6 Cognitive Screening

    Time frame: Initial Visit (within 5 days of injury) and Final Visit (up to 4 weeks post injury)

    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.

  2. ChildSCAT6 Cognitive Screening

    Time frame: Initial visit (within 5 days of injury) and Final Study Visit (up to 4 weeks post injury)

    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.

  3. GAD-7

    Time frame: Initial Visit (within 5 days of injury) and Final Visit (up to 4 weeks post injury)

    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.

  4. PHQ-9

    Time frame: Initial Visit (within 5 days of injury) and Final Visit (up to 4 weeks post injury)

    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.

  5. 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)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Nathan Cook, Ph.D.

CONTACT

[email protected]

401-874-2665

Sponsors and collaborators

Lead sponsor

University of Rhode Island

Other

Collaborators

  • Hasbro Children's Hospital
  • Rhode Island Hospital
  • The Warren Alpert Medical School of Brown University

Registry information

Official study title

Specialist and Pediatrician Co-Management for Early and Effective Concussion Care Delivery to Hasten Your Recovery (SPEEDY Recovery): A Pilot Study

Acronym: SPEEDYRecovery

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 30, 2026
Registry last updated
Jul 30, 2026

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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