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CompletedNCT00255112Updated Jun 11, 2015

TAFF-Psychological Treatment of Separation Anxiety Disorder

An interventional study of family based cognitive behavior therapy in Separation Anxiety Disorder, sponsored by University Hospital, Basel, Switzerland. Completed at 1 site in Switzerland. Open to participants aged 5 Years to 13 Years. Per ClinicalTrials.gov, last updated 2015-06-11.

Sponsored by University Hospital, Basel, Switzerland · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
5 Years to 13 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Separation Anxiety Disorder

Keywords

  • SAD
  • treatment
  • cognitive behavior therapy
  • family
  • children
  • anxiety
03

In context

Anxiety, Separation

59 studies on the registry are indexed under Anxiety, Separation; 5 are open to participants now.

This study's enrollment of 64 is close to the median of 68 across 53 interventional studies indexed under Anxiety, Separation.

Browse Anxiety, Separation studies →

Lead sponsor

University Hospital, Basel, Switzerland is the lead sponsor of 990 studies on the registry; 189 are open to participants now.

Browse University Hospital, Basel, Switzerland studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 13 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Primary diagnosis of SAD
  • Age 5 to 13 years
  • Knowledge of German language
  • Consent to randomization and psychological testing

Exclusion criteria

Exclusion Criteria:

  • Comorbid Pervasive Developmental Disorders
  • Active psychotropic drugs
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
64 participants (actual)

Study arms

  • 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

Interventions

  • Behavioralfamily based cognitive behavior therapy

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

06

What researchers measure

Primary outcomes

  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 outcomes

  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

07

Study locations

1 site
  • Institute of Psychology
    Basel, Basel-Stadt 4055, Switzerland
08

References and documents

Publications

  • 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. PubMed 21494062 ↗

Related links

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2004 and a primary completion of Dec 2009. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 16, 2005
First posted
Nov 17, 2005
Start
Jun 2004
Primary completionActual
Dec 2009
Last update
Jun 11, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 11, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00255112
Lead sponsor
University Hospital, Basel, Switzerland
Collaborators
Swiss National Science Foundation
Responsible party
Sponsor
First posted
Nov 17, 2005
Start date
Jun 2004
Primary completion
Dec 2009
Last update
Jun 11, 2015

Study contacts

Silvia Schneider, Prof. Dr.
study chair · Ruhr-Universität, Bochum, Germany

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.

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