School-based Treatment for Anxious Children
| Tracking Information | |||||
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| First Received Date ICMJE | September 25, 2007 | ||||
| Last Updated Date | April 25, 2012 | ||||
| Start Date ICMJE | October 2006 | ||||
| Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Anxiety Disorders Interview Schedule for DSM-IV: Child Version [ Time Frame: Measured at pre-treatment, post-treatment, and one month follow-up ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
DSM-IV Anxiety Disorders Interview Schedule [ Time Frame: Measured at pre- and post-treatment ] | ||||
| Change History | Complete list of historical versions of study NCT00536094 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Screen for Child Anxiety Related Disorders (SCARED) - Child Version [ Time Frame: Measured at pre-treatment, post-treatment, and one month follow-up ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
Screen for Child Anxiety Related Disorders (SCARED) - Child Version [ Time Frame: Measured at pre- and post-treatment ] | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | School-based Treatment for Anxious Children | ||||
| Official Title ICMJE | School-Based CBT for Anxious African-American Children | ||||
| Brief Summary | This study will determine the effectiveness of a school-based cognitive behavior therapy in urban, predominantly low-income, African-American children diagnosed with an anxiety disorder. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Anxiety Disorders | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| 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. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 40 | ||||
| Completion Date | December 2009 | ||||
| Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 7 Years to 17 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00536094 | ||||
| Other Study ID Numbers ICMJE | R34 MH074552, DSIR 84-CTS | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Golda Ginsburg, National Institute of Mental Health (NIMH) | ||||
| Study Sponsor ICMJE | National Institute of Mental Health (NIMH) | ||||
| Collaborators ICMJE | Johns Hopkins University | ||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||
| Verification Date | April 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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