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

NCT ID: NCT00569829

Last Updated: 2012-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2009-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Separation Anxiety Disorder Generalized Anxiety Disorder Social Phobia

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

Cognitive behavioral therapy

Group Type EXPERIMENTAL

cognitive behavioral therapy

Intervention Type BEHAVIORAL

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

2

Waitlist

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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cognitive behavioral therapy

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

5 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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Jeffrey J. Wood

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeffrey J Wood, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Other Identifiers

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G04-06-117-04

Identifier Type: -

Identifier Source: org_study_id