School-based Treatment for Anxious Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00536094
Recruitment Status : Completed
First Posted : September 27, 2007
Last Update Posted : September 24, 2013
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Golda S. Ginsburg, Ph.D., National Institute of Mental Health (NIMH)

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.

Condition or disease Intervention/treatment Phase
Anxiety Disorders Behavioral: Cognitive behavioral therapy (CBT) Behavioral: Treatment as usual (TAU) Phase 3

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 : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
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

Primary Outcome Measures :
  1. Anxiety Disorders Interview Schedule for DSM-IV: Child Version [ Time Frame: Measured at pre-treatment, post-treatment, and one month follow-up ]

Secondary Outcome Measures :
  1. Screen for Child Anxiety Related Disorders (SCARED) - Child Version [ Time Frame: Measured at pre-treatment, post-treatment, and one month follow-up ]

Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00536094

United States, Maryland
Johns Hopkins School of Medicine
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
National Institute of Mental Health (NIMH)
Principal Investigator: Golda Ginsburg, PhD Johns Hopkins School of Medicine

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.

Responsible Party: Golda S. Ginsburg, Ph.D., Professor, National Institute of Mental Health (NIMH) Identifier: NCT00536094     History of Changes
Other Study ID Numbers: R34MH074552 ( U.S. NIH Grant/Contract )
First Posted: September 27, 2007    Key Record Dates
Last Update Posted: September 24, 2013
Last Verified: April 2012

Keywords provided by Golda S. Ginsburg, Ph.D., National Institute of Mental Health (NIMH):
Cognitive behavioral therapy
African American

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders