TAFF-Psychological Treatment of Separation Anxiety Disorder

Separation Anxiety Disorder Clinical Trial

Official title:

Psychological Treatment of Separation Anxiety Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00255112
• Other study ID #: PP001--68701
• Secondary ID: Trennungsangstpr
• Status: Completed
• Phase: N/A
• First received: November 16, 2005
• Last updated: June 10, 2015
• Start date: June 2004

Study information

• Verified date: June 2015
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 13 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorders
• Anxiety, Separation
• Mental Disorders
• Separation Anxiety Disorder

Intervention

Behavioral:
• family based cognitive behavior therapy
newly developed family based cognitive behavior therapy for children with separation anxiety disorder over 5 years old

Locations

Country	Name	City	State
Switzerland	Institute of Psychology	Basel	Basel-Stadt

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Swiss National Science Foundation

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DSM-IV criteria for Separation Anxiety Disorder		December 2009	No
Primary	Global Success Rating (GSR)		December 2009	No
Primary	Separation Anxiety Inventory for Children (SAI)		December 2009	No
Secondary	Revised Children's Manifest Anxiety Scale (RCMAS)		December 2009	No
Secondary	Sheehan Disability Scale (SDS)		December 2009	No
Secondary	Inventory for the Assessment of Quality of Life in Children and Adolescents (IQL)		December 2009	No

External Links

•   Link
•   Link