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A Study Comparing Two Treatments for Child With Anxiety

A Randomized-controlled Study Comparing Two Treatments for Children With Anxiety Disorders

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01624584
Enrollment
15
Registered
2012-06-20
Start date
2012-06-30
Completion date
2014-08-31
Last updated
2015-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety

Keywords

child, anxiety, CBT

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.

Interventions

six sessions of child anxiety treatment

BEHAVIORALTraditional Treatment

six sessions of treatment consistent with current practice

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
7 Years to 17 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Pediatric Anxiety Rating ScaleTime 2Changes in PARS rating from time 1 to time 2 will be compared

Secondary

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

Other

MeasureTime frameDescription
AttritionTime 3Attrition in each condition will be assessed

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026