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Main
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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. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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4 May 2013 |
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Main ID: |
DRKS00004431 |
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Date of registration:
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07/11/2012 |
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Primary sponsor: |
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Public title:
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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)
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Scientific title:
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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 |
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Date of first enrolment:
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08/10/2012 |
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Target sample size:
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102 |
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Recruitment status: |
Recruiting |
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URL:
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http://www.drks.de/DRKS00004431 |
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Study type:
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interventional |
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Study design:
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Allocation: Non-randomized controlled trial;. Masking: Open (masking not used). Control: Active control. Assignment: Parallel. Study design purpose: Treatment;
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Countries of recruitment
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Germany
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Contacts
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Name:
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Monica
Biscaldi-Schäfer |
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Address:
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Hauptstr. 8
79104
Freiburg
Germany |
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Telephone:
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0761 27088010 |
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Email:
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monica.biscaldi-schaefer@uniklinik-freiburg.de |
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Affiliation:
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Universitätsklinik für Psychiatrie u. Psychosomatik, Abteilung für Psychiatrie und Psychotherapie im
Kindes- und Jugendalter |
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Name:
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Monica
Biscaldi-Schäfer |
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Address:
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Hauptstr. 8
79104
Freiburg
Germany |
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Telephone:
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0761 27088010 |
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Email:
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monica.biscaldi-schaefer@uniklinik-freiburg.de |
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Affiliation:
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Universitätsklinik für Psychiatrie u. Psychosomatik, Abteilung für Psychiatrie und Psychotherapie im
Kindes- und Jugendalter |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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F84.0 - Childhood autism
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F84.1 - Atypical autism
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F84.5 - Asperger's syndrome
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Intervention(s)
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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
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Primary Outcome(s)
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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.
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Secondary Outcome(s)
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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).
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Source(s) of Monetary Support
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Universitätsklinik für Psychiatrie u. Psychosomatik, Abteilung für Psychiatrie und Psychotherapie im
Kindes- und Jugendalter
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