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Effectiveness of a School-Based Cognitive Behavior Therapy in Treating African American Children With Anxiety Disorders

This study is currently recruiting participants.
Information provided by National Institute of Mental Health (NIMH)

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Descriptive Information Fields
Brief Title  Effectiveness of a School-Based Cognitive Behavior Therapy in Treating African American Children With Anxiety Disorders
Official Title  School-Based Treatment for Anxious Children
Brief Summary

This study will determine the effectiveness of a school-based cognitive behavior therapy in African American children diagnosed with an anxiety disorder.

Detailed Description

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 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 open-label 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 monthly booster sessions will be held for responders in both groups at Weeks 4, 8, and 12. 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 to assess anxiety symptoms and disorders immediately following the last treatment session. Parent, teacher, and clinician ratings will also be used to assess the treatment outcomes of each child.

Study Phase Phase II
Study Type  Interventional
Study Design  Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary Outcome Measure  DSM-IV Anxiety Disorders Interview Schedule [ Time Frame: Measured at pre- and post-treatment ] [ Designated as safety issue: Yes ]
Secondary Outcome Measure  Screen for Child Anxiety Related Disorders (SCARED) - Child Version [ Time Frame: Measured at pre- and post-treatment ] [ Designated as safety issue: No ]
Condition  Anxiety Disorders
Intervention  Behavioral: Cognitive behavioral therapy (CBT)
Behavioral: Treatment as usual (TAU)
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  10
Start Date  October 2006
Completion Date December 2009
Eligibility Criteria 

Inclusion Criteria:

  • Identifies race as African American
  • Meets DSM-IV criteria for primary diagnosis of generalized anxiety disorder (GAD), social anxiety disorder (SAD), specific phobia (SP), or social phobia (SOP)
  • Received a score of at least 4 on the ADIS-C's Clinician's Severity Rating Scale (CSR) for GAD, SAD, SP, and/or SOP
  • Received a minimum 1 point difference in ADIS-IV-C severity scores between the primary disorder and other disorders (e.g., depressive disorders, disruptive behavior disorders, attention deficit hyperactive disorder [ADHD], and other anxiety disorders such as obsessive compulsive disorder [OCD], post-traumatic stress disorder [PTSD], acute stress disorder)

Exclusion Criteria:

  • Diagnosed with a pervasive developmental disorder, mental retardation, organic mental disorders, schizophrenia, or other psychotic disorders
  • Psychotic or suicidal
  • Currently receiving treatment for anxiety
  • Requires immediate or alternative treatment
  • Previously failed a trial of at least 10 sessions for anxiety within 2 years of study entry
  • Absent 50% of school days in the 2 months preceding random assignment to treatment groups
  • History of child abuse and requires ongoing Department of Social Services supervision
Gender Both
Ages 7 Years to 12 Years
Accepts Healthy Volunteers No
Contacts ††
Contact: Golda Ginsburg, PhD     410-955-1544     gginsbu@jhmi.edu    
Contact: Kimberly Becker, PhD     443-287-4349     kbecke15@jhmi.edu    
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00536094
Organization ID R34 MH074552
Secondary IDs †† DSIR 84-CTS
Study Sponsor  National Institute of Mental Health (NIMH)
Collaborators ††
Investigators 
Principal Investigator:     Golda Ginsburg, PhD     Johns Hopkins School of Medicine    
Information Provided By National Institute of Mental Health (NIMH)
Verification Date March 2008
First Received Date  September 25, 2007
Last Updated Date March 6, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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