TAFF-Psychological Treatment of Separation Anxiety Disorder

June 10, 2015 updated by: University Hospital, Basel, Switzerland

Psychological Treatment of Separation Anxiety Disorder

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Basel-Stadt
      • Basel, Basel-Stadt, Switzerland, 4055
        • Institute of Psychology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 11 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Collaborators

Swiss National Science Foundation

Investigators

  • Study Chair: Silvia Schneider, Prof. Dr., Ruhr-Universität, Bochum, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Primary Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

November 16, 2005

First Submitted That Met QC Criteria

November 16, 2005

First Posted (Estimate)

November 17, 2005

Study Record Updates

Last Update Posted (Estimate)

June 11, 2015

Last Update Submitted That Met QC Criteria

June 10, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PP001--68701
  • Trennungsangstprojekt NZX 1303

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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