School-based Treatment for Anxious Children

NCT ID: NCT00536094

Last Updated: 2013-09-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2009-12-31

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.

Conditions

Anxiety Disorders

Keywords

Cognitive behavioral therapy; Youth; School; African American

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

1

Participants will receive cognitive behavioral therapy for anxiety that includes exposure

Group Type: EXPERIMENTAL

Cognitive behavioral therapy (CBT)

Intervention Type: BEHAVIORAL

CBT includes 45-minute psychotherapy sessions once a week for a period of approximately 12 weeks.

2

Participants will receive treatment as usual as delivered by school-based clinicians

Group Type: ACTIVE_COMPARATOR

Treatment as usual (TAU)

Intervention Type: BEHAVIORAL

TAU includes 45-minute psychosocial treatment sessions once a week for a period of approximately 12 weeks.

Interventions

Cognitive behavioral therapy (CBT)

CBT includes 45-minute psychotherapy sessions once a week for a period of approximately 12 weeks.

Intervention Type: BEHAVIORAL

Treatment as usual (TAU)

TAU includes 45-minute psychosocial treatment sessions once a week for a period of approximately 12 weeks.

Intervention Type: BEHAVIORAL

Other Intervention Names

CBT; TAU

Eligibility Criteria

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Golda S. Ginsburg, Ph.D.

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Golda Ginsburg, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins School of Medicine

Locations

Johns Hopkins School of Medicine

Baltimore, Maryland, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

Other Identifiers

R34MH074552

Identifier Type: NIH

Identifier Source: secondary_id

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DSIR 84-CTS

Identifier Type: -

Identifier Source: secondary_id

R34MH074552

Identifier Type: NIH

Identifier Source: org_study_id

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