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School-based Treatment for Anxious Children

Primary Purpose

Anxiety Disorders

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Cognitive behavioral therapy (CBT)
Treatment as usual (TAU)
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorders focused on measuring Cognitive behavioral therapy, Youth, School, African American

Eligibility Criteria

7 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Johns Hopkins School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Participants will receive cognitive behavioral therapy for anxiety that includes exposure

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

Outcomes

Primary Outcome Measures

Anxiety Disorders Interview Schedule for DSM-IV: Child Version

Secondary Outcome Measures

Screen for Child Anxiety Related Disorders (SCARED) - Child Version

Full Information

First Posted
September 25, 2007
Last Updated
September 23, 2013
Sponsor
Johns Hopkins University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00536094
Brief Title
School-based Treatment for Anxious Children
Official Title
School-Based CBT for Anxious African-American Children
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders
Keywords
Cognitive behavioral therapy, Youth, School, African American

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Participants will receive cognitive behavioral therapy for anxiety that includes exposure
Arm Title
2
Arm Type
Active Comparator
Arm Description
Participants will receive treatment as usual as delivered by school-based clinicians
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioral therapy (CBT)
Other Intervention Name(s)
CBT
Intervention Description
CBT includes 45-minute psychotherapy sessions once a week for a period of approximately 12 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Treatment as usual (TAU)
Other Intervention Name(s)
TAU
Intervention Description
TAU includes 45-minute psychosocial treatment sessions once a week for a period of approximately 12 weeks.
Primary Outcome Measure Information:
Title
Anxiety Disorders Interview Schedule for DSM-IV: Child Version
Time Frame
Measured at pre-treatment, post-treatment, and one month follow-up
Secondary Outcome Measure Information:
Title
Screen for Child Anxiety Related Disorders (SCARED) - Child Version
Time Frame
Measured at pre-treatment, post-treatment, and one month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Golda Ginsburg, PhD
Organizational Affiliation
Johns Hopkins School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

Citations:
Citation
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.
Results Reference
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School-based Treatment for Anxious Children

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