A Study Comparing Two Treatments for Child With Anxiety

Sponsor
Mayo Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT01624584
Collaborator
(none)
15
1
2
26
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Study Details

Study Description

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
  • 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 Design

Study Type:
Interventional
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 :
Jun 1, 2012
Actual Primary Completion Date :
Aug 1, 2014
Actual Study Completion Date :
Aug 1, 2014

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Pediatric Anxiety Rating Scale [Time 2]

      Changes in PARS rating from time 1 to time 2 will be compared

    Secondary Outcome Measures

    1. Pediatric Anxiety Rating Scales [Time 3]

      Decrease in anxiety ratings from Time 1 to Time 3 will be compared between groups

    Other Outcome Measures

    1. Attrition [Time 3]

      Attrition in each condition will be assessed

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    7 Years to 17 Years
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic in Rochester Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

    • Principal Investigator: Stephen Whiteside, PhD, LP, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Stephen Whiteside, PH D, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT01624584
    Other Study ID Numbers:
    • 11-008970
    First Posted:
    Jun 20, 2012
    Last Update Posted:
    Apr 10, 2015
    Last Verified:
    Apr 1, 2015
    Keywords provided by Stephen Whiteside, PH D, Mayo Clinic
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 10, 2015