School-based Treatment for Anxious Children

Phase 3

Completed

• Conditions: Anxiety Disorders
• Interventions: Behavioral: Cognitive behavioral therapy (CBT); Behavioral: Treatment as usual (TAU)

• Registration Number: NCT00536094
• Lead Sponsor: Johns Hopkins University

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.

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 Timeline

• Study Start: 2006-10
• Study First Submitted: 2007-09-25
• Study First Submitted QC: 2007-09-25
• Study First Posted: 2007-09-27
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2012-04
• Last Update Submitted: 2013-09-23
• Last Update Posted: 2013-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Cognitive behavioral therapy (CBT)	Participants will receive cognitive behavioral therapy for anxiety that includes exposure
2	Treatment as usual (TAU)	Participants will receive treatment as usual as delivered by school-based clinicians

Primary Outcome Measures

Name	Time	Method
Anxiety Disorders Interview Schedule for DSM-IV: Child Version	Measured at pre-treatment, post-treatment, and one month follow-up

Secondary Outcome Measures

Name	Time	Method
Screen for Child Anxiety Related Disorders (SCARED) - Child Version	Measured at pre-treatment, post-treatment, and one month follow-up

Trial Locations

Locations (1)

Johns Hopkins School of Medicine; 🇺🇸 Baltimore, Maryland, United States