Clinical trial NCT00769925: Assessing Different Methods of Anxiety Care in Pediatric Settings
Official title: Improving Care for Anxiety in Pediatric Settings
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Anxiety Disorders
Keywords: Generalized Anxiety
Social Phobia
Separation Anxiety
Phobia
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2008-10-09
Enrollment: 0
Sex: ALL
Minimum age (years): 8
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: Clinical Severity Rating on Anxiety Diagnostic Interview Schedule for Children for primary anxiety disorder
timeFrame: Measured at pre-treatment and post-treatment
Secondary outcomes:
measure: Clinical Global Impression scale-Improvement Change
timeFrame: Measured at pre-treatment, mid-treatment, post-treatment, and a 3-month follow-up
measure: Screening for Anxiety Related Emotional Disorders (SCARED) parent and child self-report scales
timeFrame: Measured at pre-treatment, mid-treatment, post-treatment, and a 3-month follow-up
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California San Diego
state: California
Study officials:
affiliation: University of California, San Diego
name: Denise A. Chavira, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chavira DA, Drahota A, Garland AF, Roesch S, Garcia M, Stein MB. Feasibility of two modes of treatment delivery for child anxiety in primary care. Behav Res Ther. 2014 Sep;60:60-6. doi: 10.1016/j.brat.2014.06.010. Epub 2014 Jul 11.