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Completed

NCT Number: NCT00255112

TAFF-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.

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Key information

Conditions

Separation Anxiety Disorder Anxiety Disorders Anxiety, Separation Mental Disorders Neurodevelopmental Disorders

Age range

5 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Psychology

Basel, Canton of Basel-City, 4055, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

family based cognitive behavior therapy

Behavioral

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

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

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • Swiss National Science Foundation

Registry information

Official study title

Psychological Treatment of Separation Anxiety Disorder

Important dates

Study start
2004
Primary completion
2009
First posted
Nov 17, 2005
Registry last updated
Jun 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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