Separation Anxiety DisorderNCT00255112
TAFF-Psychological Treatment of Separation Anxiety Disorder
A study testing family based cognitive behavior therapy in people with Separation Anxiety Disorder, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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 more about this study
- Who is it for?
- Ages 5 to 13 years
- Conditions the study is for
- Separation Anxiety Disorder
- What is being tested?
- family based cognitive behavior therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2004to Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Primary diagnosis of SAD
- Age 5 to 13 years
- Knowledge of German language
- Consent to randomization and psychological testing
Who cannot join
- Comorbid Pervasive Developmental Disorders
- Active psychotropic drugs
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Institute of Psychology
Basel, Canton of Basel-City, 4055
About this study
Official title: 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.
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.
- Conditions
- Separation Anxiety Disorder
- Being tested
- family based cognitive behavior therapy
- Keywords
- SAD, treatment, cognitive behavior therapy, family, children, anxiety
- Medical subject headings
- Anxiety, Separation, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
family based cognitive behavior therapyBehavioural
newly developed family based cognitive behavior therapy for children with separation anxiety disorder over 5 years old
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | 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. |
| 2 | Active comparator | 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. Receives: Behavioral: family based cognitive behavior therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
DSM-IV criteria for Separation Anxiety Disorder
Measured: December 2009
Global Success Rating (GSR)
Measured: December 2009
Separation Anxiety Inventory for Children (SAI)
Measured: December 2009
Secondary outcomes (3)
Revised Children's Manifest Anxiety Scale (RCMAS)
Measured: December 2009
Sheehan Disability Scale (SDS)
Measured: December 2009
Inventory for the Assessment of Quality of Life in Children and Adolescents (IQL)
Measured: December 2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2005 (estimated)
- Study startJun 2004
- Primary completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Separation Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation
- Responsible party
- Sponsor
- Investigators
- Silvia Schneider, Prof. Dr., Study chair, Ruhr-Universität, Bochum, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00255112
- Sponsor's protocol ID
- PP001--68701
- Other IDs
- Trennungsangstprojekt NZX 1303
- Status last verified
- Jun 2015
- First submitted
- 16 Nov 2005
- Last updated
- 11 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Treatment of Separation Anxiety Disorder
- ClinicalTrials.gov ID
- NCT00255112
- Acronym / sponsor ID
- PP001--68701
- Conditions
- Separation Anxiety Disorder
- Keywords
- SAD, treatment, cognitive behavior therapy, family, children, anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation
- Study start
- Jun 2004
- Primary completion
- Dec 2009 (actual)
- First posted
- 17 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –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. |
| 2 | Active comparator | Behavioral: family based cognitive behavior therapyThe 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. |
Who may qualify
- Ages
- 5 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Primary diagnosis of SAD
- Age 5 to 13 years
- Knowledge of German language
- Consent to randomization and psychological testing
Key exclusion criteria (2 listed)
- Comorbid Pervasive Developmental Disorders
- Active psychotropic drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| family based cognitive behavior therapynewly developed family based cognitive behavior therapy for children with separation anxiety disorder over 5 years old | Behavioural | 2 |
Primary outcome
DSM-IV criteria for Separation Anxiety Disorder
Time frame: December 2009
Global Success Rating (GSR)
Time frame: December 2009
Separation Anxiety Inventory for Children (SAI)
Time frame: December 2009
3 secondary outcomes
Revised Children's Manifest Anxiety Scale (RCMAS)
Time frame: December 2009
Sheehan Disability Scale (SDS)
Time frame: December 2009
Inventory for the Assessment of Quality of Life in Children and Adolescents (IQL)
Time frame: December 2009
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2015.
- Derived from this study: PubMed 21494062Schneider 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.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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Obsessive Compulsive Disorder (OCD), Anxiety Disorder of Childhood or Adolescence
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Silvia Schneider, Prof. Dr. study chair
Ruhr-Universität, Bochum, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing family based cognitive behavior therapy in people with Separation Anxiety Disorder, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DSM-IV criteria for Separation Anxiety Disorder (time frame: December 2009). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00255112, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2015.