Plain English Summary
Background and study aims
Children often have anxiety disorders. They are usually treated by psychodynamic therapies in Germany. There are not a lot of studies evaluating whether this type of treatment works for children. This is the aim of this study.
Who can participate?
Children between 7 and 13 diagnosed with anxiety disorder, generalized anxiety disorder, or social anxiety disorder.
What does the study involve?
After initial assessment, participants are randomly allocated to one of two groups: a short-term psychotherapy group (intervention) or a waiting list group (control). Participants that are allocated to the waiting list group will receive the treatment after the waiting period has elapsed.
What are the possible benefits and risks of participating?
We expect that the intervention will reduce anxiety symptoms. If symptoms of anxiety increase for participants in the waiting list group, they will start treatment immediately. There are no further risks.
Where is the study run from?
The lead center is Clinic of Psychosomatic Medicine and Psychotherapy, University of Goettingen, Germany. Other centres include the International Psychoanalytic University IPU Berlin, Germany and the Heidelberg University Hospital, General Psychiatry, University of Heidelberg, Germany.
When is the study starting and how long is it expected to run for?
November 2014 to November 2018.
Who is funding the study?
Vereinigung Analytischer Kinder-und Jugendlichenpsychotherapeuten in Deutschland e.V. VAKJP
Stiftung zur Foerderung der universitaeren Psychoanalyse
Foerderverein für analytische Kinder- und Jugendpsychotherapie e.V. Krefeld
Who is the main contact?
Dr Simone Salzer
simone.salzer@medizin.uni-goettingen.de
Trial website
Contact information
Type
Scientific
Primary contact
Dr Simone Salzer
ORCID ID
Contact details
Clinic of Psychosomatic Medicine and Psychotherapy
Center of Psychosocial Medicine
Georg-August-University Goettingen
Von-Siebold-Str. 5
Goettingen
37075
Germany
+49 (0) 551 39 8997
simone.salzer@medizin.uni-goettingen.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Efficacy of manualized short-term psychodynamic therapy for separation anxiety disorder, generalized anxiety disorder and social anxiety disorder in children: a randomized controlled multicenter trial
Acronym
ASK-Studie
Study hypothesis
Manualized psychodynamic therapy is more effective in reducing symptoms of separation anxiety disorder/generalized anxiety disorder/social anxiety disorder than waiting list control.
Ethics approval
Ethics Committee of the Medical Faculty of the University of Goettingen, 01/08/2014
Study design
Randomized controlled multicenter trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Anxiety disorders in children (separation anxiety disorder, generalized anxiety disorder, social anxiety disorder)
Intervention
Manualized psychodynamic short-term psychotherapy versus waiting list condition (16 weeks)
Intervention type
Behavioural
Phase
Drug names
Primary outcome measures
Response defined as at least 30% reduction of ADIS-C/P-IV CSR ratings for the primary diagnosis or ADIS-C/P CSR ≤3 rating for the primary diagnosis (ADIS-C/P) (Silverman & Albano, 2008) by trained experts unaware of group assignment. Primary outcomes are measured at baseline, after 2, 4, 8, 12 and 16 months (and additionally after 20 months for patients from the waiting list).
Secondary outcome measures
1. Rates of remission
2. CGI
3. TAI-R-K or SPAIK or PSWQ-K (dependent on primary diagnosis)
4. SCARED
5. SDQ
6. DIKJ
7. Familienboegen
8. FTB
9. EQ-5D-Y for children
Secondary outcomes are measured at baseline, after 2, 4, 8, 12 and 16 months (and additionally after 20 months for patients from the waiting list).
Overall trial start date
10/11/2014
Overall trial end date
10/11/2018
Reason abandoned
Eligibility
Participant inclusion criteria
1. Primary diagnosis of separation anxiety disorder, generalized anxiety disorder or social anxiety disorder according to DSM-IV/-5
2. Aged 7 to 13 years old
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
174
Participant exclusion criteria
1. Psychotic disorders
2. Substance-related disorders
3. Organic mental disorders
4. Severe medical conditions
5. IQ ˂ 80
6. Post-traumatic stress disorder (PTSD)
7. Severe attention deficit hyperactivity disorder (ADHD)
8. Suicidal ideation
9. Concurrent psychotherapeutic or psychopharmacological treatment
Recruitment start date
24/11/2014
Recruitment end date
10/11/2018
Locations
Countries of recruitment
Germany
Trial participating centre
Clinic of Psychosomatic Medicine and Psychotherapy
Goettingen
37075
Germany
Trial participating centre
International Psychoanalytic University (IPU)
Berlin
Germany
Trial participating centre
Heidelberg University Hospital, General Psychiatry, University of Heidelberg
Heidelberg
Germany
Sponsor information
Organisation
University Medical Center Goettingen (Germany)
Sponsor details
Georg-August-Universitaet
Robert-Koch-Straße 40
37075 Goettingen
Goettingen
37075
Germany
-
ifs@med.uni-goettingen.de
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Vereinigung Analytischer Kinder-und Jugendlichenpsychotherapeuten in Deutschland e.V. VAKJP (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Stiftung zur Foerderung der universitaeren Psychoanalyse (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Foerderverein für analytische Kinder- und Jugendpsychotherapie e.V. Krefeld (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary