Assessing Different Methods of Anxiety Care in Pediatric Settings

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by University of California, San Diego.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Denise A. Chavira, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00769925
First received: October 8, 2008
Last updated: January 6, 2012
Last verified: January 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   8 Years to 13 Years
Genders Eligible for Study:   Both
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
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: NCT00769925

Locations
United States, California
University of California San Diego
San Diego, California, United States, 92123
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Denise A. Chavira, PhD University of California, San Diego
  More Information

No publications provided

Responsible Party: Denise A. Chavira, Associate Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT00769925     History of Changes
Other Study ID Numbers: K01 MH072952, K01MH072952, DSIR 84-CTS
Study First Received: October 8, 2008
Last Updated: January 6, 2012
Health Authority: United States: Federal Government

Keywords provided by University of California, San Diego:
Generalized Anxiety
Social Phobia
Separation Anxiety
Phobia

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 27, 2014