Assessing Different Methods of Anxiety Care in Pediatric Settings

Anxiety Disorders Clinical Trial

Official title:

Improving Care for Anxiety in Pediatric Settings

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00769925
• Other study ID #: K01MH072952
• Secondary ID: K01MH072952DSIR
• Status: Withdrawn
• Phase: N/A
• Start date: November 2008
• Est. completion date: February 2012

Study information

• Verified date: August 2019
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 13 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of California San Diego	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Severity Rating on Anxiety Diagnostic Interview Schedule for Children for primary anxiety disorder		Measured at pre-treatment and post-treatment
Secondary	Clinical Global Impression scale-Improvement Change		Measured at pre-treatment, mid-treatment, post-treatment, and a 3-month follow-up
Secondary	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