Telehealth Specialty Concussion Treatment for Youth
ConditionConcussion
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-17
SponsorUniversity of Rhode Island
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
youth aged 8 to 17
At least one parent/caregiver present and willing to participate
English proficiency
access to an internet connected device,
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
Specialist and Pediatrician Co-Management for Early and Effective Concussion Care Delivery to Hasten Your Recovery (SPEEDY Recovery)
BehavioralThe 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).
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Telehealth consultationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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)2
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)3
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)Secondary outcomes
1
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)2
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)3
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)4
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Rhode Island
Lead sponsor
Hasbro Children's Hospital
Collaborator
Rhode Island Hospital
Collaborator
The Warren Alpert Medical School of Brown University
Collaborator
Source ClinicalTrials.gov
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