Status:
COMPLETED
A Study of Family-based Cognitive-behavioral Therapy for Chronic Pediatric Headache and Anxiety
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Migraine Research Foundation
Conditions:
Pediatric
Headache
Eligibility:
All Genders
7-17 years
Phase:
NA
Brief Summary
The primary aim of this proposal is to refine the intervention under investigation (i.e., family-based CBT) and evaluate the feasibility and acceptability of the intervention and methods (e.g., recrui...
Detailed Description
Chronic daily headache in children, as well as periodic migraine, is a prevalent, persistent, and debilitating pain condition affecting nearly 1 in 10 children. Emerging evidence suggests that affecte...
Eligibility Criteria
Inclusion
- To determine eligibility, youth will complete an evaluation consisting of clinical interviews, self-, and parent-report measures.
- To be included in the study, all children must:
- have a current diagnosis of chronic daily headache, tension-type headache, and/or migraine headache
- obtain a total score on the Screen for Child Anxiety Related Disorders (SCARED) in the clinical range (i.e., \> 20)
- be between 7 and 17 years old
- have a parent/guardian who gives consent and agrees to participate
- be English speaking
- not currently participating in other psychosocial treatments specifically directed at reducing head pain or anxiety.
- For youth receiving prophylactic medication, it is preferable that they remain on a stable dose and agree to avoid medication changes while enrolled in the study. Thus, all participants will be permitted to continue with their prescribed medical/neurological treatment, however the use of medications (both prophylactic and over-the-counter analgesics) will be closely monitored.
Exclusion
- Youth will be excluded from the study if they have a medical or psychiatric condition contraindicating study treatment or warranting an alternative intervention (e.g., suicidality, depression).
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01182051
Start Date
March 1 2010
End Date
June 1 2012
Last Update
May 24 2013
Active Locations (1)
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1
Johns Hopkins
Baltimore, Maryland, United States, 21205