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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00769925 |
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 |
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Anxiety Disorders |
Behavioral: Cognitive Behavior Therapy-Primary Care Behavioral: Therapist-Assisted Bibliotherapy-Primary Care |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | Improving Care for Anxiety in Pediatric Settings |
Estimated Enrollment: | 52 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Therapist Assisted Bibliotherapy-Primary Care (TAB-PC): Experimental |
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.
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Cognitive Behavior Therapy-Primary Care (CBT-PC): Experimental |
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.
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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.
Ages Eligible for Study: | 8 Years to 13 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Rebeca Saucedo, BA | 858-966-7703 ext 6901 | resaucedo@ucsd.edu |
Contact: Denise A. Chavira, PhD | 858-966-7703 ext 2824 | dchavira@ucsd.edu |
United States, California | |
University of California San Diego | Recruiting |
San Diego, California, United States, 92123 |
Principal Investigator: | Denise A. Chavira, PhD | University of California, San Diego |
Responsible Party: | University of California, San Diego ( Denise A. Chavira, PhD ) |
Study ID Numbers: | K01 MH072952, DSIR 84-CTS |
Study First Received: | October 8, 2008 |
Last Updated: | December 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00769925 |
Health Authority: | United States: Federal Government |
Generalized Anxiety Social Phobia Separation Anxiety Phobia |
Anxiety Disorders Mental Disorders Anxiety, Separation Phobic Disorders |