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Not yet recruiting NCT07736534

Telehealth Specialty Concussion Treatment for Youth

No phase Interventional Concussion

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Specialist and Pediatrician Co-Management for Early and Effective Concussion Care Delivery to Hasten Your Recovery (SPEEDY Recovery).
Who it may be relevant to
Registry conditions: Concussion. Basic parameters: 8 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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 yout

Primary outcome measures

  • SCAT6 Symptom Questionnaire [Time frame: Initial visit (within 5 days of injury), once per week through study completion (up to 4 weeks post injury)]
  • ChildSCAT6 Symptom Questionnaire [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) [Time frame: Final Study Visit (up to 4 weeks post injury)]
Secondary outcome measures (5)
  • 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)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Hasbro Children's Hospital — Providence

Identifiers

NCT: NCT07736534 · 2526-316

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗