This trial is active, not recruiting.

Condition anxiety disorders
Treatments cognitive behavior therapy-primary care, therapist-assisted bibliotherapy-primary care
Sponsor University of California, San Diego
Collaborator National Institute of Mental Health (NIMH)
Start date November 2008
End date January 2012
Trial size 52 participants
Trial identifier NCT00769925, DSIR 84-CTS, K01 MH072952, K01MH072952


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
therapist-assisted bibliotherapy-primary care Parent Training
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.
cognitive behavior therapy-primary care Cognitive-Behavioral Therapy
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.

Primary Outcomes

Clinical Severity Rating on Anxiety Diagnostic Interview Schedule for Children for primary anxiety disorder
time frame: Measured at pre-treatment and post-treatment

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 8 years up to 13 years old.

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

Additional Information

Official title Improving Care for Anxiety in Pediatric Settings
Principal investigator Denise A. Chavira, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2012.
Information provided to ClinicalTrials.gov by University of California, San Diego.