NCT00536094

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2006

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 27, 2007

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

September 24, 2013

Status Verified

April 1, 2012

Enrollment Period

3.2 years

First QC Date

September 25, 2007

Last Update Submit

September 23, 2013

Conditions

Anxiety Disorders

Keywords

Cognitive behavioral therapyYouthSchoolAfrican American

Outcome Measures

Primary Outcomes (1)

  • Anxiety Disorders Interview Schedule for DSM-IV: Child Version

    Measured at pre-treatment, post-treatment, and one month follow-up

Secondary Outcomes (1)

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

    Measured at pre-treatment, post-treatment, and one month follow-up

Study Arms (2)

1

EXPERIMENTAL

Participants will receive cognitive behavioral therapy for anxiety that includes exposure

Behavioral: Cognitive behavioral therapy (CBT)

2

ACTIVE COMPARATOR

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

Behavioral: Treatment as usual (TAU)

Interventions

Cognitive behavioral therapy (CBT)BEHAVIORAL

CBT includes 45-minute psychotherapy sessions once a week for a period of approximately 12 weeks.

Also known as: CBT
1
Treatment as usual (TAU)BEHAVIORAL

TAU includes 45-minute psychosocial treatment sessions once a week for a period of approximately 12 weeks.

Also known as: TAU
2

Eligibility Criteria

Age7 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins School of Medicine

Baltimore, Maryland, 21287, United States

Location

Related Publications (1)

  • 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.

    BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Cognitive Behavioral TherapyTherapeutics

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Golda Ginsburg, PhD

    Johns Hopkins School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 25, 2007

First Posted

September 27, 2007

Study Start

October 1, 2006

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

September 24, 2013

Record last verified: 2012-04

Locations

US(1)