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Completed

NCT Number: NCT00569829

Modular Cognitive Behavioral Therapy for the Treatment of Child Anxiety Disorders in Elementary School Settings

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The child meets DSM-IV criteria for separation anxiety disorder (SAD), social phobia, or generalized anxiety disorder (GAD) based on a diagnostic interview
  • The child is not taking any psychiatric medication at the initial assessment, or is taking a stable dose of psychiatric medication (i.e., at least one month at a stable dose prior to the baseline assessment)
  • If medication is being used, children will maintain that dose throughout the study

Exclusion criteria

  • The child is currently in psychotherapy
  • The family is currently in family therapy or a parenting class
  • The child begins taking psychiatric medication or increases his/her dose of medication during the intervention
  • For any reason the child or parents appear unable to participate in the intervention program.

Treatment and study plan

Cognitive behavioral therapy

Behavioral

1 to 16 weekly sessions of modular cognitive behavioral therapy, each lasting 60-80 minutes

Primary outcomes

  1. Clinician's Global Impressions-Improvement (CGI) scale

    Time frame: Posttreatment / postwaitlist

Secondary outcomes

  1. Anxiety Disorders Interview Schedule IV: Child and Parent Version

    Time frame: Posttreatment / postwaitlist

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Registry information

Official study title

A Randomized, Controlled Trial of Modular CBT for Child Anxiety Disorders in Elementary School Settings

Acronym: KATES

Important dates

Study start
2004
Primary completion
2008
Study completion
2009
First posted
Dec 7, 2007
Registry last updated
Mar 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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