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A Study Comparing Two Treatments for Child With Anxiety

Primary Purpose

Anxiety

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Experimental treatment
Traditional Treatment
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety focused on measuring child, anxiety, CBT

Eligibility Criteria

7 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental treatment

Traditional Treatment

Arm Description

6 sessions of anxiety treatment

Six sessions of anxiety treatment

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 13, 2012
Last Updated
April 8, 2015
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT01624584
Brief Title
A Study Comparing Two Treatments for Child With Anxiety
Official Title
A Randomized-controlled Study Comparing Two Treatments for Children With Anxiety Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Data Monitoring Committee
No

5. 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?
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
Keywords
child, anxiety, CBT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental treatment
Arm Type
Experimental
Arm Description
6 sessions of anxiety treatment
Arm Title
Traditional Treatment
Arm Type
Active Comparator
Arm Description
Six sessions of anxiety treatment
Intervention Type
Behavioral
Intervention Name(s)
Experimental treatment
Other Intervention Name(s)
CBT, Cognitive behavioral therapy
Intervention Description
six sessions of child anxiety treatment
Intervention Type
Behavioral
Intervention Name(s)
Traditional Treatment
Other Intervention Name(s)
CBT, Cognitive behavioral therapy
Intervention Description
six sessions of treatment consistent with current practice
Primary Outcome Measure Information:
Title
Pediatric Anxiety Rating Scale
Description
Changes in PARS rating from time 1 to time 2 will be compared
Time Frame
Time 2
Secondary Outcome Measure Information:
Title
Pediatric Anxiety Rating Scales
Description
Decrease in anxiety ratings from Time 1 to Time 3 will be compared between groups
Time Frame
Time 3
Other Pre-specified Outcome Measures:
Title
Attrition
Description
Attrition in each condition will be assessed
Time Frame
Time 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants must have: a primary DSM-IV anxiety disorder diagnosis, including generalized anxiety disorder, obsessive compulsive disorder, panic disorder, separation anxiety disorder, social and specific phobias 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: history of and/or current psychosis, autism, bipolar disorder, or current suicidality, oppositional defiant disorder, or eating disorder principal diagnosis other than one of the anxiety disorders listed for inclusion criteria 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Whiteside, PhD, LP
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

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A Study Comparing Two Treatments for Child With Anxiety

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