Telehealth Specialty Concussion Treatment for Youth

NCT07736534 | Not Yet Recruiting

• 1 other identifier: 2526-316
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Concussion

Keywords

concussion; telehealth; access to care; children; adolescents

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Final Study Visit (up to 4 weeks post injury)

Secondary Outcomes (5)

• SCAT6 Cognitive Screening

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

• ChildSCAT6 Cognitive Screening

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

• GAD-7

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

• PHQ-9

  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)

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

Study Arms (1)

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).

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

Interventions

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).

Telehealth consultation

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Hasbro Children's Hospital

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Central Study Contacts

Nathan Cook, Ph.D.

CONTACT

401-874-2665; nathan.cook@uri.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: July 30, 2026
• Study Start: July 18, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 15, 2027
• Last Updated: July 30, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

US (1)