Assessing Different Methods of Anxiety Care in Pediatric Settings
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|ClinicalTrials.gov Identifier: NCT00769925|
Recruitment Status : Unknown
Verified January 2012 by Denise A. Chavira, University of California, San Diego.
Recruitment status was: Active, not recruiting
First Posted : October 9, 2008
Last Update Posted : January 10, 2012
|Condition or disease||Intervention/treatment||Phase|
|Anxiety Disorders||Behavioral: Cognitive Behavior Therapy-Primary Care Behavioral: Therapist-Assisted Bibliotherapy-Primary Care||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||52 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Improving Care for Anxiety in Pediatric Settings|
|Study Start Date :||November 2008|
|Estimated Primary Completion Date :||January 2012|
|Estimated Study Completion Date :||February 2012|
|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.
|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.
- Clinical Severity Rating on Anxiety Diagnostic Interview Schedule for Children for primary anxiety disorder [ Time Frame: Measured at pre-treatment and post-treatment ]
- 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 ]
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
|United States, California|
|University of California San Diego|
|San Diego, California, United States, 92123|
|Principal Investigator:||Denise A. Chavira, PhD||University of California, San Diego|