School-based Treatment for Anxious Children

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Golda S. Ginsburg, Ph.D., National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00536094
First received: September 25, 2007
Last updated: September 23, 2013
Last verified: April 2012
  Purpose

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 Intervention Phase
Anxiety Disorders
Behavioral: Cognitive behavioral therapy (CBT)
Behavioral: Treatment as usual (TAU)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: School-Based CBT for Anxious African-American Children

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 40
Study Start Date: October 2006
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   7 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00536094

Locations
United States, Maryland
Johns Hopkins School of Medicine
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Golda Ginsburg, PhD Johns Hopkins School of Medicine
  More Information

Publications:
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)
ClinicalTrials.gov Identifier: NCT00536094     History of Changes
Other Study ID Numbers: R34 MH074552, R34MH074552, DSIR 84-CTS
Study First Received: September 25, 2007
Last Updated: September 23, 2013
Health Authority: United States: Federal Government

Keywords provided by Johns Hopkins University:
Cognitive behavioral therapy
Youth
School
African American

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 24, 2014