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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00569829
Acronym
KATES
Enrollment
60
Registered
2007-12-07
Start date
2004-01-31
Completion date
2009-06-30
Last updated
2012-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Generalized Anxiety Disorder, Separation Anxiety Disorder, Social Phobia

Keywords

cognitive behavioral therapy, anxiety disorders, school-based intervention, randomized, controlled trial

Brief summary

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.

Interventions

BEHAVIORALcognitive behavioral therapy

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

Sponsors

University of California, Los Angeles
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
5 Years to 12 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Clinician's Global Impressions-Improvement (CGI) scalePosttreatment / postwaitlist

Secondary

MeasureTime frame
Anxiety Disorders Interview Schedule IV: Child and Parent VersionPosttreatment / postwaitlist

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026