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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: German Clinical Trials Register
Last refreshed on: 29 June 2014
Main ID:  DRKS00004431
Date of registration: 07/11/2012
Primary sponsor: Universitätsklinik für Psychiatrie u. Psychosomatik, Abteilung für Psychiatrie und Psychotherapie im Kindes- und Jugendalter
Public title: Evaluation of the Freiburg Social Skills Training Program with Focus on Theory of Mind for Children and Adolescents with High-Functioning Autism Spectrum Disorders (TOMTASS)
Scientific title: Evaluation of the Freiburg Social Skills Training Program with Focus on Theory of Mind for Children and Adolescents with High-Functioning Autism Spectrum Disorders (TOMTASS) - TOMTASS-E
Date of first enrolment: 08/10/2012
Target sample size: 102
Recruitment status: Recruiting
URL:  http://www.drks.de/DRKS00004431
Study type:  interventional
Study design:  Allocation: Non-randomized controlled trial;. Masking: Open (masking not used). Control: Active control. Assignment: Parallel. Study design purpose: Treatment;  
Countries of recruitment
Germany
Contacts
Name: Monica  Biscaldi-Schäfer
Address:  Hauptstr. 8 79104 Freiburg Germany
Telephone: 0761 27088010
Email: monica.biscaldi-schaefer@uniklinik-freiburg.de
Affiliation:  Universitätsklinik für Psychiatrie u. Psychosomatik, Abteilung für Psychiatrie und Psychotherapie im Kindes- und Jugendalter
Name: Monica  Biscaldi-Schäfer
Address:  Hauptstr. 8 79104 Freiburg Germany
Telephone: 0761 27088010
Email: monica.biscaldi-schaefer@uniklinik-freiburg.de
Affiliation:  Universitätsklinik für Psychiatrie u. Psychosomatik, Abteilung für Psychiatrie und Psychotherapie im Kindes- und Jugendalter
Key inclusion & exclusion criteria
Inclusion criteria: F84.0, F84.1, F84.5 Diagnosis according to ICD-10.
IQ > 70
Signed informed consent.

Exclusion criteria: Not meeting inclusion criteria; missing informed consent.

Age minimum: 7 Years
Age maximum: 18 Years
Gender: Both, male and female
Health Condition(s) or Problem(s) studied
F84.0 - Childhood autism
F84.1 - Atypical autism
F84.5 - Asperger's syndrome
Intervention(s)
Intervention 1: The intervention group is treated with TOMTASS (Theory of mind training in autism spectrum disorders). 12 therapy sessions, once a week, 120 minutes each. Intervention 2: The control group has treatment as usual
Primary Outcome(s)
1. Change in total T-score of the Social Responsiveness Scale (SRS) as assessed by the primary caretaker (PC), and
2. change in total score of the Inventory of Life Quality in Children and Adolescents (ILC) (parent und child version)
both measured
a. between baseline and end of intervention (pre - post)
b. between baseline and 6 months after end of intervention (pre - follow-up)
as compared to treatment as usual.
Secondary Outcome(s)
Measured before and after the intervention (pre - post) :
1. Change in theory of mind abilities and emotion recognition in comparison to treatment as usual
2. Change in social skills (blinded rating of video recordings of the sessions).

Measured after the intervention:
1. Assessment of therapy outcome by participants, their parents and the therapists (measured with FBB).
Secondary ID(s)
370/12
Source(s) of Monetary Support
Universitätsklinik für Psychiatrie u. Psychosomatik, Abteilung für Psychiatrie und Psychotherapie im Kindes- und Jugendalter
Secondary Sponsor(s)
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