School-based Treatment for Anxious Children

Sponsor

Johns Hopkins University (Other)

Overall Status

Completed

CT.gov ID

NCT00536094

Collaborator

National Institute of Mental Health (NIMH) (NIH)

Enrollment

Location

Arms

Duration (Months)

1.1

Patients Per Site Per Month

Study Details

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.

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 Design

Study Type:

Interventional

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 :

Oct 1, 2006

Actual Primary Completion Date :

Dec 1, 2009

Actual Study Completion Date :

Dec 1, 2009

Arms and Interventions

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 Names: 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 Names: TAU

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 Names:

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 Names:

TAU

Outcome Measures

Primary Outcome Measures

Anxiety Disorders Interview Schedule for DSM-IV: Child Version [Measured at pre-treatment, post-treatment, and one month follow-up]

Secondary Outcome Measures

Screen for Child Anxiety Related Disorders (SCARED) - Child Version [Measured at pre-treatment, post-treatment, and one month follow-up]

Eligibility Criteria

Criteria

Ages Eligible for Study:

7 Years to 17 Years

Sexes Eligible for Study:

All

Accepts 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