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Assessing Different Methods of Anxiety Care in Pediatric Settings

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2012 by Denise A. Chavira, University of California, San Diego.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00769925
First Posted: October 9, 2008
Last Update Posted: January 10, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Denise A. Chavira, University of California, San Diego
  Purpose
This study will compare the effectiveness of delivering cognitive behavioral therapy for children with anxiety disorders through in-person contact versus through workbooks and telephone communication.

Condition Intervention
Anxiety Disorders Behavioral: Cognitive Behavior Therapy-Primary Care Behavioral: Therapist-Assisted Bibliotherapy-Primary Care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving Care for Anxiety in Pediatric Settings

Resource links provided by NLM:


Further study details as provided by Denise A. Chavira, University of California, San Diego:

Primary Outcome Measures:
  • Clinical Severity Rating on Anxiety Diagnostic Interview Schedule for Children for primary anxiety disorder [ Time Frame: Measured at pre-treatment and post-treatment ]

Secondary Outcome Measures:
  • Clinical Global Impression scale-Improvement Change [ Time Frame: Measured at pre-treatment, mid-treatment, post-treatment, and a 3-month follow-up ]
  • Screening for Anxiety Related Emotional Disorders (SCARED) parent and child self-report scales [ Time Frame: Measured at pre-treatment, mid-treatment, post-treatment, and a 3-month follow-up ]

Estimated Enrollment: 52
Study Start Date: November 2008
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Therapist Assisted Bibliotherapy-Primary Care (TAB-PC) Behavioral: Therapist-Assisted Bibliotherapy-Primary Care
Parents will receive educational workbooks and ongoing support over the phone from a child anxiety specialist to learn how to use cognitive behavioral therapy skills to manage their children's fears and worries.
Other Names:
  • Parent Training
  • Self-help
  • Therapist Assisted Bibliotherapy
Experimental: Cognitive Behavior Therapy-Primary Care (CBT-PC) Behavioral: Cognitive Behavior Therapy-Primary Care
Children will receive cognitive behavioral therapy from a child anxiety specialist at their doctor's office (the primary care clinic). The children will learn skills to cope with fear and anxiety, and parents will learn how to support their children in using these new skills.
Other Names:
  • Cognitive-Behavioral Therapy
  • CBT
  • Family CBT

Detailed Description:

Approximately 13% of adolescents aged 9 to 17 suffer from an anxiety disorder, which can cause disruptive fear, worry, or uneasiness that impairs their normal functioning. These anxiety disorders can include generalized anxiety disorder (GAD), phobias, panic disorder, and obsessive-compulsive disorder (OCD), and they often co-occur with a second anxiety disorder or another mental or behavioral disorder, like depression. Research on interventions such as cognitive behavioral therapy (CBT) indicates that these interventions are helpful to children who suffer from anxiety disorders, but are not always used. This study will examine the feasibility of implementing CBT for children between the ages of 8 and 13 in two different forms: through in-person contact at the pediatric primary care setting and through telephone-based contact.

Participants in this study will be randomly assigned to receive either cognitive behavioral therapy in primary care (CBT-PC) or therapist-assisted bibliotherapy in primary care (TAB-PC). In CBT-PC, participants will have therapy administered by a child anxiety specialist, and the parents of participants will learn how to support the new skills their children learn in therapy. In TAB-PC, parents will receive educational workbooks and ongoing support over the phone from a child anxiety specialist to learn how to use CBT skills to manage their children's fears and worries. Participation in this study will last 3 to 4 months, with therapy visits occuring once a week at the beginning and tapering to once every other week at the end of treatment. At pre-treatment, mid-treatment, post-treatment, and a 3-month follow-up, participants will undergo structured clinical interviews to assess their anxiety levels and the severity of their conditions.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Meets DSM-IV criteria for one of the following disorders: separation anxiety disorder, social phobia, generalized anxiety disorder, specific phobia, or obsessive-compulsive disorder
  • Takes a medication and has maintained a stable dose for 3 months before baseline assessment
  • Pediatric medical care is provided through one of the participating primary care clinics
  • Parent and child are fluent in English

Exclusion Criteria:

  • Presence of a life threatening condition or a medical illness that would make participation unsafe
  • Diagnosed with bipolar disorder I, mental retardation, or autism or has psychotic symptoms
  • Acutely suicidal or homicidal or exhibiting dangerous behavior
  • Parents do not consent for diagnosis and progress to be shared with their child's primary care physician
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00769925


Locations
United States, California
University of California San Diego
San Diego, California, United States, 92123
Sponsors and Collaborators
University of California, San Diego
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Denise A. Chavira, PhD University of California, San Diego
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Denise A. Chavira, Associate Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT00769925     History of Changes
Other Study ID Numbers: K01MH072952 ( U.S. NIH Grant/Contract )
DSIR 84-CTS
First Submitted: October 8, 2008
First Posted: October 9, 2008
Last Update Posted: January 10, 2012
Last Verified: January 2012

Keywords provided by Denise A. Chavira, University of California, San Diego:
Generalized Anxiety
Social Phobia
Separation Anxiety
Phobia

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders