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| Descriptive Information Fields | |||||||||
| Brief Title † | Effectiveness of a School-Based Cognitive Behavior Therapy in Treating African American Children With Anxiety Disorders | ||||||||
| Official Title † | School-Based Treatment for Anxious Children | ||||||||
| Brief Summary | This study will determine the effectiveness of a school-based cognitive behavior therapy in African American children diagnosed with an anxiety disorder. |
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| Detailed Description | Anxiety disorders are among the most common childhood disorders. Although anxiety is a normal part of life and growing up, for some children this anxiety becomes chronic, relentless, and progressively worse if left untreated. Physical symptoms typically accompany the intense anxiety caused by the disorder and may include blushing, profuse sweating, trembling, nausea, and difficulty talking. Anxiety disorders among children have become increasingly prevalent, indicating that excessive fear, worry, and anxiety in children are emerging public health issues. Recent studies have shown that CBT is an effective form of treatment for childhood anxiety disorders; however, it often requires the use of expert CBT clinicians. The purpose of this study is to deliver a school-based version of CBT to low-income, inner-city African-American children with anxiety disorders. Clinicians within the school will undergo CBT training and adapt the treatment program to fit the needs of the participating children. All participants in this open-label study will undergo an initial evaluation to assess anxiety symptoms, disorders, and associated impairments. The children will then be randomly assigned to receive 12 weekly sessions of school-based CBT or treatment as usual, which will involve 12 weekly sessions of psychosocial treatment. Three monthly booster sessions will be held for responders in both groups at Weeks 4, 8, and 12. All treatment sessions will occur at school during the day and will be led by school-based clinicians. A follow-up session will be conducted to assess anxiety symptoms and disorders immediately following the last treatment session. Parent, teacher, and clinician ratings will also be used to assess the treatment outcomes of each child. |
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| Study Phase | Phase II | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study | ||||||||
| Primary Outcome Measure † | DSM-IV Anxiety Disorders Interview Schedule [ Time Frame: Measured at pre- and post-treatment ] [ Designated as safety issue: Yes ] | ||||||||
| Secondary Outcome Measure † | Screen for Child Anxiety Related Disorders (SCARED) - Child Version [ Time Frame: Measured at pre- and post-treatment ] [ Designated as safety issue: No ] | ||||||||
| Condition † | Anxiety Disorders | ||||||||
| Intervention † | Behavioral: Cognitive behavioral therapy (CBT) Behavioral: Treatment as usual (TAU) |
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 10 | ||||||||
| Start Date † | October 2006 | ||||||||
| Completion Date | December 2009 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 7 Years to 12 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00536094 | ||||||||
| Organization ID | R34 MH074552 | ||||||||
| Secondary IDs †† | DSIR 84-CTS | ||||||||
| Study Sponsor † | National Institute of Mental Health (NIMH) | ||||||||
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||||||
| Verification Date | March 2008 | ||||||||
| First Received Date † | September 25, 2007 | ||||||||
| Last Updated Date | March 6, 2008 | ||||||||