A Study Comparing Two Treatments for Child With Anxiety

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01624584
Recruitment Status : Completed
First Posted : June 20, 2012
Last Update Posted : April 10, 2015
Information provided by (Responsible Party):
Stephen Whiteside, Mayo Clinic

Brief Summary:

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 or disease Intervention/treatment Phase
Anxiety Behavioral: Experimental treatment Behavioral: Traditional Treatment Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized-controlled Study Comparing Two Treatments for Children With Anxiety Disorders
Study Start Date : June 2012
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Pediatric Anxiety Rating Scale [ Time Frame: Time 2 ]
    Changes in PARS rating from time 1 to time 2 will be compared

Secondary Outcome Measures :
  1. Pediatric Anxiety Rating Scales [ Time Frame: Time 3 ]
    Decrease in anxiety ratings from Time 1 to Time 3 will be compared between groups

Other Outcome Measures:
  1. Attrition [ Time Frame: Time 3 ]
    Attrition in each condition will be assessed

Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01624584

United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Principal Investigator: Stephen Whiteside, PhD, LP Mayo Clinic

Responsible Party: Stephen Whiteside, PH D, Mayo Clinic Identifier: NCT01624584     History of Changes
Other Study ID Numbers: 11-008970
First Posted: June 20, 2012    Key Record Dates
Last Update Posted: April 10, 2015
Last Verified: April 2015

Keywords provided by Stephen Whiteside, Mayo Clinic:

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders