Assessing Different Methods of Anxiety Care in Pediatric Settings

NCT00769925 | Withdrawn DMC

• 2 other identifiers: K01MH072952DSIR 84-CTS
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety Disorders

Keywords

Generalized Anxiety; Social Phobia; Separation Anxiety; Phobia

Outcome Measures

Primary Outcomes (1)

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

  Measured at pre-treatment and post-treatment

Secondary Outcomes (2)

• 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

Study Arms (2)

Therapist Assisted Bibliotherapy-Primary Care (TAB-PC)

EXPERIMENTAL

Behavioral: Therapist-Assisted Bibliotherapy-Primary Care

Cognitive Behavior Therapy-Primary Care (CBT-PC)

EXPERIMENTAL

Behavioral: Cognitive Behavior Therapy-Primary Care

Interventions

Cognitive Behavior Therapy-Primary Care BEHAVIORAL

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.

Also known as: Cognitive-Behavioral Therapy, CBT, Family CBT

Cognitive Behavior Therapy-Primary Care (CBT-PC)

Therapist-Assisted Bibliotherapy-Primary Care BEHAVIORAL

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.

Also known as: Parent Training, Self-help, Therapist Assisted Bibliotherapy

Therapist Assisted Bibliotherapy-Primary Care (TAB-PC)

Eligibility Criteria

• Age: 8 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of California San Diego

San Diego, California, 92123, United States

Location

Related Publications (1)

• 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.

  PMID: 25075802 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Generalized Anxiety Disorder; Phobia, Social; Anxiety, Separation; Phobic Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Mental Disorders; Neurodevelopmental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Denise A. Chavira, PhD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2008
• First Posted: October 9, 2008
• Study Start: November 1, 2008
• Primary Completion: January 1, 2012
• Study Completion: February 1, 2012
• Last Updated: August 15, 2019

Record last verified: 2019-08

Locations

US (1)