A Phase 2 interventional study of cognitive behavioral therapy in Separation Anxiety Disorder, Generalized Anxiety Disorder and Social Phobia, sponsored by University of California, Los Angeles. Completed. Open to participants aged 5 Years to 12 Years. Per ClinicalTrials.gov, last updated 2012-03-30.
Sponsored by University of California, Los Angeles · Phase 2, Interventional, and Treatment
Although cognitive behavioral therapy (CBT) has been found to be efficacious in the treatment of child anxiety disorders, little progress has been made in the dissemination of such treatments to real-world practice settings. Clinical trials conducted in practice settings can demonstrate the degree to which evidence-based treatments are appropriate for larger scale dissemination. This study evaluates CBT as a treatment for child anxiety disorders in the elementary school clinic setting. A randomized, controlled trial design has been employed, comparing immediate treatment and a three-month waitlist. The trial is being conducted in several Los Angeles area elementary schools and is only available to children in these particular schools. To ensure that the CBT intervention is flexible and capable of matching the characteristics of various school settings, clinicians, and referred children, a modular treatment approach is employed. The study design includes elements to ensure high quality data, such as the use of independent evaluators and tests of treatment fidelity. Children, ages 5 to 12 years, are referred by teachers and staff or are identified as having high anxiety in concurrent studies. All participating children have DSM-IV diagnoses of separation anxiety disorder, generalized anxiety disorder, or social phobia, according to a semi-structured diagnostic interview. Therapy and clinical supervision is provided by the research team. It is hypothesized that children receiving immediate treatment will have significantly lower anxiety scores than children assigned to the waitlist at the posttreatment/postwaitlist assessment. If results are favorable, further exploration of dissemination of CBT into school clinic settings may be indicated.
59 studies on the registry are indexed under Anxiety, Separation; 5 are open to participants now.
This study's enrollment of 60 is below the median of 68 across 53 interventional studies indexed under Anxiety, Separation.
Browse Anxiety, Separation studies →University of California, Los Angeles is the lead sponsor of 1,170 studies on the registry; 195 are open to participants now.
Of its 95 completed or terminated interventional studies of FDA-regulated products, 70 (74%) have results posted.
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The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cognitive behavioral therapy
Behavioral: cognitive behavioral therapy
Waitlist
1 to 16 weekly sessions of modular cognitive behavioral therapy, each lasting 60-80 minutes
Clinician's Global Impressions-Improvement (CGI) scale
Time frame: Posttreatment / postwaitlist
Anxiety Disorders Interview Schedule IV: Child and Parent Version
Time frame: Posttreatment / postwaitlist
No study locations are listed for this record.
The record gives a start of Jan 2004, a primary completion of Jun 2008 and a completion of Jun 2009. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.
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