TAFF-Psychological Treatment of Separation Anxiety Disorder

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether a specific family based cognitive behavioral treatment program is effective in the treatment of children with separation anxiety disorder.

Detailed Description
-----------------
Anxiety disorders are the most common mental disorders both in adulthood and childhood. Recent research indicates that anxiety disorders in childhood and in particular Separation Anxiety Disorder (SAD) increase the risk of mental disorders in adulthood. Despite these results research on SAD is still limited compared to the vast research activity on adult anxiety disorders. The proposed research program will close a gap of current international research: It will test the efficacy of a family based cognitive behavioral treatment program specific for SAD. The research program consists of two parts. One study is aimed at children with SAD aged 5 to 7. 40 children are randomly allocated immediately to SAD-specific family-based treatment or to a wait list. For the second study 60 children with SAD (8 to 13 years old) are randomly allocated to either SAD-specific family-based treatment (SAD-CBT) or a well established global CBT program for childhood anxiety disorders (global CBT). In both studies treatment success is tested at the end of treatment as well as 4 weeks and 1, 2 and 3 years after treatment.

Official Title
-----------------
Psychological Treatment of Separation Anxiety Disorder

Conditions
-----------------
Separation Anxiety Disorder

Intervention / Treatment
-----------------
* Behavioral: family based cognitive behavior therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary diagnosis of SAD Age 5 to 13 years Knowledge of German language Consent to randomization and psychological testing Exclusion Criteria: Comorbid Pervasive Developmental Disorders Active psychotropic drugs

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 13 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br>The present study evaluates the efficacy of a family-based CBT treatment specifically tailored to children with SAD, developed at the University of Basel. The study consists of 40 participants (5-7 years old) with SAD and their families. Participants were randomly assigned to 12 weeks of SAD-specific family-based CBT treatment or to waitlist condition. | |
| Active Comparator: 2<br>The present study evaluates the efficacy of a family-based CBT treatment specifically tailored to children with SAD, developed at the University of Basel in comparison to a global CBT treatment. The study consists of 60 participants (between 8 and 13 years old), randomly assigned to one of the two treatments. | Behavioral: family based cognitive behavior therapy<br>* newly developed family based cognitive behavior therapy for children with separation anxiety disorder over 5 years old<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DSM-IV criteria for Separation Anxiety Disorder |  | December 2009 | 
| Global Success Rating (GSR) |  | December 2009 | 
| Separation Anxiety Inventory for Children (SAI) |  | December 2009 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Revised Children's Manifest Anxiety Scale (RCMAS) |  | December 2009 | 
| Sheehan Disability Scale (SDS) |  | December 2009 | 
| Inventory for the Assessment of Quality of Life in Children and Adolescents (IQL) |  | December 2009 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SAD, treatment, cognitive behavior therapy, family, children, anxiety