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Sponsored by: |
National Institute of Mental Health (NIMH) |
Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00536094 |
This study will determine the effectiveness of a school-based cognitive behavior therapy in urban, predominantly low-income, African-American children diagnosed with an anxiety disorder.
Condition | Intervention | Phase |
Anxiety Disorders |
Behavioral: Cognitive behavioral therapy (CBT) Behavioral: Treatment as usual (TAU) |
Phase III |
MedlinePlus related topics: | Anxiety |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | School-Based CBT for Anxious African-American Children |
Estimated Enrollment: | 40 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
Participants will receive cognitive behavioral therapy for anxiety that includes exposure
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Behavioral: Cognitive behavioral therapy (CBT)
CBT includes 45-minute psychotherapy sessions once a week for a period of approximately 12 weeks.
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2: Active Comparator
Participants will receive treatment as usual as delivered by school-based clinicians
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Behavioral: Treatment as usual (TAU)
TAU includes 45-minute psychosocial treatment sessions once a week for a period of approximately 12 weeks.
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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 predominantly 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 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 parent sessions will be offered for families in both groups at Weeks 2, 6, and 10. 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 at post-treatment and 1 month after the last session to assess anxiety symptoms and disorders. Parent, teacher, and clinician ratings will also be used to assess the treatment outcomes of each child.
Ages Eligible for Study: | 7 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Golda Ginsburg, PhD | 410-955-1544 | gginsbu@jhmi.edu |
Contact: Kimberly Becker, PhD | 410-614-3317 | kbecke15@jhmi.edu |
United States, Maryland | |||||
Johns Hopkins School of Medicine | Recruiting | ||||
Baltimore, Maryland, United States, 21287 |
Principal Investigator: | Golda Ginsburg, PhD | Johns Hopkins School of Medicine |
Responsible Party: | Johns Hopkins University ( Golda Ginsburg, PhD, Associate Professor ) |
Study ID Numbers: | R34 MH074552, DSIR 84-CTS |
First Received: | September 25, 2007 |
Last Updated: | October 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00536094 |
Health Authority: | United States: Federal Government |
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