A Study Comparing Two Treatments for Child With Anxiety
A Randomized-controlled Study Comparing Two Treatments for Children With Anxiety Disorders
1 other identifier
interventional
15
1 country
1
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?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 anxiety
Started Jun 2012
Typical duration for phase_3 anxiety
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 13, 2012
CompletedFirst Posted
Study publicly available on registry
June 20, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedApril 10, 2015
April 1, 2015
2.2 years
June 13, 2012
April 8, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pediatric Anxiety Rating Scale
Changes in PARS rating from time 1 to time 2 will be compared
Time 2
Secondary Outcomes (1)
Pediatric Anxiety Rating Scales
Time 3
Other Outcomes (1)
Attrition
Time 3
Study Arms (2)
Experimental treatment
EXPERIMENTAL6 sessions of anxiety treatment
Traditional Treatment
ACTIVE COMPARATORSix sessions of anxiety treatment
Interventions
six sessions of child anxiety treatment
six sessions of treatment consistent with current practice
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephen Whiteside, PhD, LP
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PH D
Study Record Dates
First Submitted
June 13, 2012
First Posted
June 20, 2012
Study Start
June 1, 2012
Primary Completion
August 1, 2014
Study Completion
August 1, 2014
Last Updated
April 10, 2015
Record last verified: 2015-04