Condition category
Mental and Behavioural Disorders
Date applied
05/11/2014
Date assigned
20/11/2014
Last edited
24/11/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

http://www.ask-studie.de

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

http://med.uni-goettingen.de

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

Publication citations

Additional files

Editorial Notes