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A Study Comparing Two Treatments for Child With Anxiety

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Stephen Whiteside, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01624584
First received: June 13, 2012
Last updated: October 23, 2013
Last verified: October 2013
  Purpose

First, can exposure therapy for childhood anxiety begin earlier in the course of treatment than current treatment manuals suggest?

Second, is treating childhood anxiety with exposure therapy more effective and efficient than treating childhood anxiety with relaxation training + cognitive restructuring?


Condition Intervention Phase
Anxiety
Behavioral: Experimental treatment
Behavioral: Traditional Treatment
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized-controlled Study Comparing Two Treatments for Children With Anxiety Disorders

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Pediatric Anxiety Rating Scale [ Time Frame: Time 2 ] [ Designated as safety issue: No ]
    Changes in PARS rating from time 1 to time 2 will be compared


Secondary Outcome Measures:
  • Pediatric Anxiety Rating Scales [ Time Frame: Time 3 ] [ Designated as safety issue: No ]
    Decrease in anxiety ratings from Time 1 to Time 3 will be compared between groups


Other Outcome Measures:
  • Attrition [ Time Frame: Time 3 ] [ Designated as safety issue: No ]
    Attrition in each condition will be assessed


Estimated Enrollment: 60
Study Start Date: June 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental treatment
6 sessions of anxiety treatment
Behavioral: Experimental treatment
six sessions of child anxiety treatment
Other Names:
  • CBT
  • Cognitive behavioral therapy
Active Comparator: Traditional Treatment
Six sessions of anxiety treatment
Behavioral: Traditional Treatment
six sessions of treatment consistent with current practice
Other Names:
  • CBT
  • Cognitive behavioral therapy

Detailed Description:

Anxiety disorders are among the most common psychiatric disorders in children and typically produce significant disruption in family, social, and academic functioning (Merikangas & Avenevoli, 2002). Fortunately, treatments for childhood anxiety have been manualized and found to be efficacious (Walkup, et al., 2008). These treatments most often incorporate aspects of cognitive-restructuring, relaxation training, and exposure to anxiety-producing stimuli. Unfortunately, many practitioners opt to utilize mainly cognitive and relaxation techniques at the expense of exposure techniques (Freiheit, Vye, Swan, & Cady, 2004). However, it remains unclear which of these components is most effective in reducing anxiety symptoms or the extent to which they act in concert; thus, the relative effectiveness of treatment for childhood anxiety when leaving-out a treatment component is unknown. The current study aims to compare the relative effectiveness of exposure therapy for childhood anxiety to cognitive restructuring and relaxation techniques. Sixty children and adolescents seeking treatment for anxiety in an outpatient pediatric anxiety clinic will be randomized to receive either six sessions of parent assisted exposure therapy or six sessions of individual cognitive restructuring and relaxation training. Comprehensive assessments will be completed by trained clinicians at pre-treatment and again at post-treatment to measure reductions in anxiety and related symptoms as well as improvements in daily functioning. We anticipate that children treated with exposure therapy will demonstrate significantly greater improvement over the six sessions than children treated with cognitive-restructuring and relaxation training, and will require fewer additional treatment sessions. Support of this hypthothesis would clarify the active ingredients in manualized treatment for childhood anxiety disorders and would potentially lead to quicker, more efficient treatment.

  Eligibility

Ages Eligible for Study:   7 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants must have:

    1. a primary DSM-IV anxiety disorder diagnosis, including generalized anxiety disorder, obsessive compulsive disorder, panic disorder, separation anxiety disorder, social and specific phobias
    2. no medication changes were made at least 8 weeks prior to initiating participation in the study and during treatment.

Exclusion Criteria:

  • Patients will be excluded from the study if they meet any of the following criteria:

    1. history of and/or current psychosis, autism, bipolar disorder, or current suicidality, oppositional defiant disorder, or eating disorder
    2. principal diagnosis other than one of the anxiety disorders listed for inclusion criteria
    3. current positive diagnosis in the child's caregiver of mental retardation, psychosis, or other psychiatric disorders or conditions that would limit his/her ability to understand CBT and follow-through with treatment directives.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01624584

Locations
United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Kay Nevinger    507-293-0089      
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Stephen Whiteside, PhD, LP Mayo Clinic
  More Information

No publications provided

Responsible Party: Stephen Whiteside, PH D, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01624584     History of Changes
Other Study ID Numbers: 11-008970
Study First Received: June 13, 2012
Last Updated: October 23, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
child
anxiety
CBT

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on November 24, 2014