A Study Comparing Two Treatments for Child With Anxiety

Phase 3

Completed

• Conditions: Anxiety
• Interventions: Behavioral: Experimental treatment; Behavioral: Traditional Treatment

• Registration Number: NCT01624584
• Lead Sponsor: 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?

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 Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-06-13
• Study First Submitted QC: 2012-06-18
• Study First Posted: 2012-06-20
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-08
• Last Update Posted: 2015-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Experimental treatment	Experimental treatment	6 sessions of anxiety treatment
Traditional Treatment	Traditional Treatment	Six sessions of anxiety treatment

Primary Outcome Measures

Name	Time	Method
Pediatric Anxiety Rating Scale	Time 2	Changes in PARS rating from time 1 to time 2 will be compared

Secondary Outcome Measures

Name	Time	Method
Pediatric Anxiety Rating Scales	Time 3	Decrease in anxiety ratings from Time 1 to Time 3 will be compared between groups

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States