Clinical trial NCT00255112: TAFF-Psychological Treatment of Separation Anxiety Disorder
Official title: Psychological Treatment of Separation Anxiety Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Separation Anxiety Disorder
Keywords: SAD
treatment
cognitive behavior therapy
family
children
anxiety
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Swiss National Science Foundation
First posted: 2005-11-17
Enrollment: 64
Sex: ALL
Minimum age (years): 5
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: DSM-IV criteria for Separation Anxiety Disorder
timeFrame: December 2009
measure: Global Success Rating (GSR)
timeFrame: December 2009
measure: Separation Anxiety Inventory for Children (SAI)
timeFrame: December 2009
Secondary outcomes:
measure: Revised Children's Manifest Anxiety Scale (RCMAS)
timeFrame: December 2009
measure: Sheehan Disability Scale (SDS)
timeFrame: December 2009
measure: Inventory for the Assessment of Quality of Life in Children and Adolescents (IQL)
timeFrame: December 2009
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Institute of Psychology
state: Basel-Stadt
Study officials:
affiliation: Ruhr-Universität, Bochum, Germany
name: Silvia Schneider, Prof. Dr.
role: STUDY_CHAIR
References:
citation: Schneider S, Blatter-Meunier J, Herren C, Adornetto C, In-Albon T, Lavallee K. Disorder-specific cognitive-behavioral therapy for separation anxiety disorder in young children: a randomized waiting-list-controlled trial. Psychother Psychosom. 2011;80(4):206-15. doi: 10.1159/000323444. Epub 2011 Apr 14.