A Phase 3 interventional study of Cognitive behavioral therapy (CBT) and Treatment as usual (TAU) in Anxiety Disorders, sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to participants aged 7 Years to 17 Years. Per ClinicalTrials.gov, last updated 2013-09-24.
Sponsored by Johns Hopkins University · Phase 3, Interventional, and Treatment
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.
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.
4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.
This study's enrollment of 40 is below the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.
Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive cognitive behavioral therapy for anxiety that includes exposure
Behavioral: Cognitive behavioral therapy (CBT)
Participants will receive treatment as usual as delivered by school-based clinicians
Behavioral: Treatment as usual (TAU)
CBT includes 45-minute psychotherapy sessions once a week for a period of approximately 12 weeks.
Also known as: CBT
TAU includes 45-minute psychosocial treatment sessions once a week for a period of approximately 12 weeks.
Also known as: TAU
Anxiety Disorders Interview Schedule for DSM-IV: Child Version
Time frame: Measured at pre-treatment, post-treatment, and one month follow-up
Screen for Child Anxiety Related Disorders (SCARED) - Child Version
Time frame: Measured at pre-treatment, post-treatment, and one month follow-up
This study is completed, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.
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Johns Hopkins University