TAFF-Psychological Treatment of Separation Anxiety Disorder

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by University Hospital, Basel, Switzerland.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Swiss National Science Foundation
Information provided by:
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT00255112
First received: November 16, 2005
Last updated: February 23, 2010
Last verified: February 2010
  Purpose

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 Intervention
Separation Anxiety Disorder
Behavioral: family based cognitive behavior therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Psychological Treatment of Separation Anxiety Disorder

Resource links provided by NLM:


Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • DSM-IV criteria for Separation Anxiety Disorder [ Time Frame: December 2009 ] [ Designated as safety issue: No ]
  • Global Success Rating (GSR) [ Time Frame: December 2009 ] [ Designated as safety issue: No ]
  • Separation Anxiety Inventory for Children (SAI) [ Time Frame: December 2009 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Revised Children's Manifest Anxiety Scale (RCMAS) [ Time Frame: December 2009 ] [ Designated as safety issue: No ]
  • Sheehan Disability Scale (SDS) [ Time Frame: December 2009 ] [ Designated as safety issue: No ]
  • Inventory for the Assessment of Quality of Life in Children and Adolescents (IQL) [ Time Frame: December 2009 ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: June 2004
Estimated Study Completion Date: June 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   5 Years to 13 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00255112

Contacts
Contact: Silvia Schneider, Prof. Dr. ++41 61 267 ext 0651 silvia.schneider@unibas.ch

Locations
Switzerland
Institute of Psychology Recruiting
Basel, Basel-Stadt, Switzerland, 4055
Contact: Silvia Schneider, Prof. Dr.    ++41 61 267 ext 0651    silvia.schneider@unibas.ch   
Principal Investigator: Silvia Schneider, Prof. Dr.         
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Swiss National Science Foundation
Investigators
Study Chair: Silvia Schneider, Prof. Dr. Department of Clinical Child and Adolescent Psychology, University of Basel, Switzerland
  More Information

Additional Information:
No publications provided by University Hospital, Basel, Switzerland

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Silvia Schneider, Klinische Kinder- und Jugendpsychologie Missionsstrasse 60 4055 Basel
ClinicalTrials.gov Identifier: NCT00255112     History of Changes
Other Study ID Numbers: PP001--68701, Trennungsangstprojekt NZX 1303
Study First Received: November 16, 2005
Last Updated: February 23, 2010
Health Authority: Switzerland: Ethikkommission

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

Additional relevant MeSH terms:
Anxiety Disorders
Anxiety, Separation
Mental Disorders
Mental Disorders Diagnosed in Childhood

ClinicalTrials.gov processed this record on July 22, 2014