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Assessing Different Methods of Anxiety Care in Pediatric Settings

Primary Purpose

Anxiety Disorders

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavior Therapy-Primary Care
Therapist-Assisted Bibliotherapy-Primary Care
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorders focused on measuring Generalized Anxiety, Social Phobia, Separation Anxiety, Phobia

Eligibility Criteria

8 Years - 13 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California San Diego

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Therapist Assisted Bibliotherapy-Primary Care (TAB-PC)

Cognitive Behavior Therapy-Primary Care (CBT-PC)

Arm Description

Outcomes

Primary Outcome Measures

Clinical Severity Rating on Anxiety Diagnostic Interview Schedule for Children for primary anxiety disorder

Secondary Outcome Measures

Clinical Global Impression scale-Improvement Change
Screening for Anxiety Related Emotional Disorders (SCARED) parent and child self-report scales

Full Information

First Posted
October 8, 2008
Last Updated
August 13, 2019
Sponsor
University of California, San Diego
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00769925
Brief Title
Assessing Different Methods of Anxiety Care in Pediatric Settings
Official Title
Improving Care for Anxiety in Pediatric Settings
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Withdrawn
Why Stopped
PI is transitioning to another institution
Study Start Date
November 2008 (Actual)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Diego
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders
Keywords
Generalized Anxiety, Social Phobia, Separation Anxiety, Phobia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Therapist Assisted Bibliotherapy-Primary Care (TAB-PC)
Arm Type
Experimental
Arm Title
Cognitive Behavior Therapy-Primary Care (CBT-PC)
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavior Therapy-Primary Care
Other Intervention Name(s)
Cognitive-Behavioral Therapy, CBT, Family CBT
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Therapist-Assisted Bibliotherapy-Primary Care
Other Intervention Name(s)
Parent Training, Self-help, Therapist Assisted Bibliotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinical Severity Rating on Anxiety Diagnostic Interview Schedule for Children for primary anxiety disorder
Time Frame
Measured at pre-treatment and post-treatment
Secondary Outcome Measure Information:
Title
Clinical Global Impression scale-Improvement Change
Time Frame
Measured at pre-treatment, mid-treatment, post-treatment, and a 3-month follow-up
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Denise A. Chavira, PhD
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25075802
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.
Results Reference
derived

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Assessing Different Methods of Anxiety Care in Pediatric Settings

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