Study Summary
This trial will test whether a multi-disciplinary intervention can improve outcomes for children who have experienced a mild TBI.
Eligible Conditions
- Concussion
Treatment Effectiveness
Effectiveness Progress
Study Objectives
5 Primary · 2 Secondary · Reporting Duration: 1 week, 2 week and 1 month post return to school
Month 1
Change in CLASS survey score
Change in Peds-QL score
Change in Post-concussion symptom inventory (PCSI) total score
2 weeks post-injury
Number of letters sent to school
3 months post injury
Post-concussion symptom inventory (PCSI) total score at 3 months post injury
3 months post-intervention
Primary Care Physician (PCP) follow up visits
Month 3
Time to return to full activity post injury
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Control Group
1 of 2
TEaM Intervention Group
1 of 2
Active Control
Experimental Treatment
1000 Total Participants · 2 Treatment Groups
Primary Treatment: TEaM Intervention · No Placebo Group · N/A
TEaM Intervention Group
Behavioral
Experimental Group · 1 Intervention: TEaM Intervention · Intervention Types: BehavioralControl Group
Behavioral
ActiveComparator Group · 1 Intervention: Standard of Care · Intervention Types: BehavioralTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 week, 2 week and 1 month post return to school
Who is running the clinical trial?
Children's Healthcare of AtlantaOTHER
159 Previous Clinical Trials
47,252 Total Patients Enrolled
Emory UniversityLead Sponsor
1,509 Previous Clinical Trials
2,705,169 Total Patients Enrolled
David Wright, MDPrincipal InvestigatorEmory University
2 Previous Clinical Trials
80 Total Patients Enrolled
Eligibility Criteria
Age Any Age · All Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You are a physician in an ED, UC, or PCP.
You are a healthcare provider.
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Conditions
Cancer Related
Treatments