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Assessing Different Methods of Anxiety Care in Pediatric Settings
This study is currently recruiting participants.
Study NCT00769925   Information provided by National Institute of Mental Health (NIMH)
First Received: October 8, 2008   Last Updated: March 17, 2009   History of Changes

October 8, 2008
March 17, 2009
November 2008
June 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00769925 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
 
Assessing Different Methods of Anxiety Care in Pediatric Settings
Improving Care for Anxiety in Pediatric Settings

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.

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.

 
Interventional
Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study
Anxiety Disorders
  • Behavioral: Cognitive Behavior Therapy-Primary Care
  • Behavioral: Therapist-Assisted Bibliotherapy-Primary Care
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
52
December 2010
June 2010   (final data collection date for primary outcome measure)

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
Both
8 Years to 13 Years
No
Contact: Amy Drahota, PhD 858-966-7703 ext 3155 adrahota@ucsd.edu
Contact: Denise A. Chavira, PhD 858-966-7703 ext 2824 dchavira@ucsd.edu
United States
 
NCT00769925
Denise A. Chavira, PhD, University of California, San Diego
K01 MH072952, DSIR 84-CTS
National Institute of Mental Health (NIMH)
 
Principal Investigator: Denise A. Chavira, PhD University of California, San Diego
National Institute of Mental Health (NIMH)
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP