TEaM Intervention for Concussion

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
ConcussionTEaM Intervention - Behavioral
Eligibility
Any Age
All Sexes
What conditions do you have?
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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

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

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: Behavioral
Control Group
Behavioral
ActiveComparator Group · 1 Intervention: Standard of Care · Intervention Types: Behavioral

Trial 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.