School-based Treatment for Anxious Children
School-Based CBT for Anxious African-American Children
Study Overview
Status
Conditions
Intervention / Treatment
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 predominantly 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 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 parent sessions will be offered for families in both groups at Weeks 2, 6, and 10. 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 at post-treatment and 1 month after the last session to assess anxiety symptoms and disorders. Parent, teacher, and clinician ratings will also be used to assess the treatment outcomes of each child.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21287
- Johns Hopkins School of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 for DSM-IV:C's Clinician's Severity Rating Scale (CSR) for GAD, SAD, SP, and/or SOP
- Received a minimum 1 point difference in ADIS for DSM-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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: 1
Participants will receive cognitive behavioral therapy for anxiety that includes exposure
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CBT includes 45-minute psychotherapy sessions once a week for a period of approximately 12 weeks.
Other Names:
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Active Comparator: 2
Participants will receive treatment as usual as delivered by school-based clinicians
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TAU includes 45-minute psychosocial treatment sessions once a week for a period of approximately 12 weeks.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Anxiety Disorders Interview Schedule for DSM-IV: Child Version
Time Frame: Measured at pre-treatment, post-treatment, and one month follow-up
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Measured at pre-treatment, post-treatment, and one month follow-up
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Screen for Child Anxiety Related Disorders (SCARED) - Child Version
Time Frame: Measured at pre-treatment, post-treatment, and one month follow-up
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Measured at pre-treatment, post-treatment, and one month follow-up
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Golda Ginsburg, PhD, Johns Hopkins School of Medicine
Publications and helpful links
General Publications
- Ginsburg, G. S., Becker, K. D., Kingery, J.,and Nichols, T. (2008). Transporting CBT for childhood anxiety disorders into inner city school-based mental health clinics. Cognitive and Behavioral Practice, 15, 148-158.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R34MH074552 (U.S. NIH Grant/Contract)
- DSIR 84-CTS (Division of Services and Intervention Research)
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