Assessing Different Methods of Anxiety Care in Pediatric Settings

Study Overview
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Brief Summary
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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
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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.

Official Title
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Improving Care for Anxiety in Pediatric Settings

Conditions
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Anxiety Disorders

Intervention / Treatment
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* Behavioral: Cognitive Behavior Therapy-Primary Care
* Behavioral: Therapist-Assisted Bibliotherapy-Primary Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Therapist Assisted Bibliotherapy-Primary Care (TAB-PC)<br> | Behavioral: Therapist-Assisted Bibliotherapy-Primary Care<br>* 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.<br>* Other names: Therapist Assisted Bibliotherapy;|
| Experimental: Cognitive Behavior Therapy-Primary Care (CBT-PC)<br> | Behavioral: Cognitive Behavior Therapy-Primary Care<br>* 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.<br>* Other names: Family CBT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Severity Rating on Anxiety Diagnostic Interview Schedule for Children for primary anxiety disorder |  | Measured at pre-treatment and post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression scale-Improvement Change |  | 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 |  | Measured at pre-treatment, mid-treatment, post-treatment, and a 3-month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Generalized Anxiety, Social Phobia, Separation Anxiety, Phobia