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TAFF-Psychological Treatment of Separation Anxiety Disorder

Primary Purpose

Separation Anxiety Disorder

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
family based cognitive behavior therapy
Sponsored by
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Separation Anxiety Disorder focused on measuring SAD, treatment, cognitive behavior therapy, family, children, anxiety

Eligibility Criteria

5 Years - 13 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institute of Psychology

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

1

2

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

DSM-IV criteria for Separation Anxiety Disorder
Global Success Rating (GSR)
Separation Anxiety Inventory for Children (SAI)

Secondary Outcome Measures

Revised Children's Manifest Anxiety Scale (RCMAS)
Sheehan Disability Scale (SDS)
Inventory for the Assessment of Quality of Life in Children and Adolescents (IQL)

Full Information

First Posted
November 16, 2005
Last Updated
June 10, 2015
Sponsor
University Hospital, Basel, Switzerland
Collaborators
Swiss National Science Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00255112
Brief Title
TAFF-Psychological Treatment of Separation Anxiety Disorder
Official Title
Psychological Treatment of Separation Anxiety Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland
Collaborators
Swiss National Science Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Separation Anxiety Disorder
Keywords
SAD, treatment, cognitive behavior therapy, family, children, anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
No Intervention
Arm Description
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.
Arm Title
2
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
family based cognitive behavior therapy
Intervention Description
newly developed family based cognitive behavior therapy for children with separation anxiety disorder over 5 years old
Primary Outcome Measure Information:
Title
DSM-IV criteria for Separation Anxiety Disorder
Time Frame
December 2009
Title
Global Success Rating (GSR)
Time Frame
December 2009
Title
Separation Anxiety Inventory for Children (SAI)
Time Frame
December 2009
Secondary Outcome Measure Information:
Title
Revised Children's Manifest Anxiety Scale (RCMAS)
Time Frame
December 2009
Title
Sheehan Disability Scale (SDS)
Time Frame
December 2009
Title
Inventory for the Assessment of Quality of Life in Children and Adolescents (IQL)
Time Frame
December 2009

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Silvia Schneider, Prof. Dr.
Organizational Affiliation
Ruhr-Universität, Bochum, Germany
Official's Role
Study Chair
Facility Information:
Facility Name
Institute of Psychology
City
Basel
State/Province
Basel-Stadt
ZIP/Postal Code
4055
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
21494062
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.
Results Reference
derived
Links:
URL
http://www.psycho.unibas.ch/index_html?content=person&detail=kontakt&person=Schneider&abteilung=Kiju
Description
Related Info
URL
http://www.taff.unibas.ch
Description
Related Info

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TAFF-Psychological Treatment of Separation Anxiety Disorder

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