Efficacy of manualized short-term psychodynamic therapy for separation anxiety disorder, generalized anxiety disorder and social anxiety disorder in children
| ISRCTN | ISRCTN11333815 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11333815 |
| Secondary identifying numbers | N/A |
- Submission date
- 05/11/2014
- Registration date
- 20/11/2014
- Last edited
- 24/11/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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
Contact information
Scientific
Clinic of Psychosomatic Medicine and Psychotherapy
Center of Psychosocial Medicine
Georg-August-University Goettingen
Von-Siebold-Str. 5
Goettingen
37075
Germany
| Phone | +49 (0) 551 39 8997 |
|---|---|
| simone.salzer@medizin.uni-goettingen.de |
Study information
| Study design | Randomized controlled multicenter trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study acronym | ASK-Studie |
| Study objectives | 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(s) | Ethics Committee of the Medical Faculty of the University of Goettingen, 01/08/2014 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 10/11/2014 |
| Completion date | 10/11/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 7 Years |
| Upper age limit | 13 Years |
| Sex | Both |
| Target number of participants | 174 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 24/11/2014 |
| Date of final enrolment | 10/11/2018 |
Locations
Countries of recruitment
- Germany
Study participating centres
37075
Germany
Germany
Germany
Sponsor information
University/education
Georg-August-Universitaet
Robert-Koch-Straße 40
37075 Goettingen
Goettingen
37075
Germany
| ifs@med.uni-goettingen.de | |
| Website | http://med.uni-goettingen.de |
"ROR" |
https://ror.org/021ft0n22 |
Funders
Funder type
Research organisation
No information available
No information available
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
