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TAFF-Psychological Treatment of Separation Anxiety Disorder

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ClinicalTrials.gov Identifier: NCT00255112
Recruitment Status : Completed
First Posted : November 17, 2005
Last Update Posted : June 11, 2015
Sponsor:
Collaborator:
Swiss National Science Foundation
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

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.

Condition or disease Intervention/treatment Phase
Separation Anxiety Disorder Behavioral: family based cognitive behavior therapy Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Psychological Treatment of Separation Anxiety Disorder
Study Start Date : June 2004
Actual Primary Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Arm Intervention/treatment
No Intervention: 1
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
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
newly developed family based cognitive behavior therapy for children with separation anxiety disorder over 5 years old



Primary Outcome Measures :
  1. DSM-IV criteria for Separation Anxiety Disorder [ Time Frame: December 2009 ]
  2. Global Success Rating (GSR) [ Time Frame: December 2009 ]
  3. Separation Anxiety Inventory for Children (SAI) [ Time Frame: December 2009 ]

Secondary Outcome Measures :
  1. Revised Children's Manifest Anxiety Scale (RCMAS) [ Time Frame: December 2009 ]
  2. Sheehan Disability Scale (SDS) [ Time Frame: December 2009 ]
  3. Inventory for the Assessment of Quality of Life in Children and Adolescents (IQL) [ Time Frame: December 2009 ]


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Ages Eligible for Study:   5 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00255112


Locations
Switzerland
Institute of Psychology
Basel, Basel-Stadt, Switzerland, 4055
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Swiss National Science Foundation
Investigators
Study Chair: Silvia Schneider, Prof. Dr. Ruhr-Universität, Bochum, Germany

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT00255112     History of Changes
Other Study ID Numbers: PP001--68701
Trennungsangstprojekt NZX 1303
First Posted: November 17, 2005    Key Record Dates
Last Update Posted: June 11, 2015
Last Verified: June 2015

Keywords provided by University Hospital, Basel, Switzerland:
SAD
treatment
cognitive behavior therapy
family
children
anxiety

Additional relevant MeSH terms:
Disease
Anxiety Disorders
Anxiety, Separation
Pathologic Processes
Mental Disorders
Neurodevelopmental Disorders