School-based Treatment for Anxious Children
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|ClinicalTrials.gov Identifier: NCT00536094|
Recruitment Status : Completed
First Posted : September 27, 2007
Last Update Posted : September 24, 2013
|Condition or disease||Intervention/treatment||Phase|
|Anxiety Disorders||Behavioral: Cognitive behavioral therapy (CBT) Behavioral: Treatment as usual (TAU)||Phase 3|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||School-Based CBT for Anxious African-American Children|
|Study Start Date :||October 2006|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||December 2009|
Participants will receive cognitive behavioral therapy for anxiety that includes exposure
Behavioral: Cognitive behavioral therapy (CBT)
CBT includes 45-minute psychotherapy sessions once a week for a period of approximately 12 weeks.
Other Name: CBT
Active Comparator: 2
Participants will receive treatment as usual as delivered by school-based clinicians
Behavioral: Treatment as usual (TAU)
TAU includes 45-minute psychosocial treatment sessions once a week for a period of approximately 12 weeks.
Other Name: TAU
- Anxiety Disorders Interview Schedule for DSM-IV: Child Version [ Time Frame: Measured at pre-treatment, post-treatment, and one month follow-up ]
- Screen for Child Anxiety Related Disorders (SCARED) - Child Version [ Time Frame: Measured at pre-treatment, post-treatment, and one month follow-up ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00536094
|United States, Maryland|
|Johns Hopkins School of Medicine|
|Baltimore, Maryland, United States, 21287|
|Principal Investigator:||Golda Ginsburg, PhD||Johns Hopkins School of Medicine|