School-based Treatment for Anxious Children

This study has been completed.
Sponsor:
Collaborator:
Johns Hopkins University
Information provided by (Responsible Party):
Golda Ginsburg, National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00536094
First received: September 25, 2007
Last updated: April 25, 2012
Last verified: April 2012

September 25, 2007
April 25, 2012
October 2006
December 2009   (final data collection date for primary outcome measure)
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 ]
DSM-IV Anxiety Disorders Interview Schedule [ Time Frame: Measured at pre- and post-treatment ]
Complete list of historical versions of study NCT00536094 on ClinicalTrials.gov Archive Site
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 ]
Screen for Child Anxiety Related Disorders (SCARED) - Child Version [ Time Frame: Measured at pre- and post-treatment ]
Not Provided
Not Provided
 
School-based Treatment for Anxious Children
School-Based CBT for Anxious African-American Children

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Anxiety Disorders
  • Behavioral: Cognitive behavioral therapy (CBT)
    CBT includes 45-minute psychotherapy sessions once a week for a period of approximately 12 weeks.
    Other Name: CBT
  • 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
  • Experimental: 1
    Participants will receive cognitive behavioral therapy for anxiety that includes exposure
    Intervention: Behavioral: Cognitive behavioral therapy (CBT)
  • Active Comparator: 2
    Participants will receive treatment as usual as delivered by school-based clinicians
    Intervention: Behavioral: Treatment as usual (TAU)
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
December 2009
December 2009   (final data collection date for primary outcome measure)

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
Both
7 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00536094
R34 MH074552, DSIR 84-CTS
Yes
Golda Ginsburg, National Institute of Mental Health (NIMH)
National Institute of Mental Health (NIMH)
Johns Hopkins University
Principal Investigator: Golda Ginsburg, PhD Johns Hopkins School of Medicine
National Institute of Mental Health (NIMH)
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP