Title {1} |
Evaluation of a three-arm, cluster-randomized controlled study to assess the effects of FASTER and SCOTT&EVA trainings for adults with high-functioning autism spectrum disorder (ASD) Trial acronym: FASTER/SCOTT Study |
Trial registration {2a and 2b}. | German Clinical Trial Register, DRKS00017817, Registered 20 April 2020. |
Protocol version {3} |
Issue Date: 3 July 2020 Trial protocol version: 1.94 Authors: LTvE, TF, UMS, OH, MK, KK, CK, VR, DW, ID |
Funding {4} | German Research Foundation (DFG TE 280/18-1; https://gepris.dfg.de/gepris/person/1462933; Deutsche Forschungsgemeinschaft) |
Author details {5a} |
Ludger Tebarzt van Elst (Corresponding Author, shared first authorship) Department of Psychiatry and Psychotherapy Medical Center – University of Freiburg, Faculty of Medicine University of Freiburg, Germany Thomas Fangmeier (shared first authorship) Department of Psychiatry and Psychotherapy Medical Center – University of Freiburg, Faculty of Medicine University of Freiburg, Germany Ulrich Max Schaller Department of Psychiatry and Psychotherapy Medical Center – University of Freiburg, Faculty of Medicine University of Freiburg, Germany Department of Child and Adolescent Psychiatry, Psychotherapy, and Psychosomatics; Medical Center, University of Freiburg, Faculty of Medicine University of Freiburg Oliver Henning Central Institute for Mental Health, Mannheim Meinhard Kieser Institute of Medical Biometry and Informatics, University Hospital Heidelberg Katja Koelkebeck LVR-Hospital Essen, department of Psychiatry and Psychotherapy, Medical Faculty, University of Duisburg-Essen Charlotte Kuepper Berlin School of Mind and Brain, Department of Psychology, Humboldt-Universitaet zu Berlin Veit Roessner Department of Child and Adolescent Psychiatry and Psychotherapy, Faculty of Medicine, TU Dresden Dirk Wildgruber Department of Psychiatry and Psychotherapy, University of Tuebingen Isabel Dziobek Berlin School of Mind and Brain, Department of Psychology, Humboldt-Universitaet zu Berlin |
Name and contact information for the trial sponsor {5b} |
Trial Sponsor: Department of Psychiatry and Psychotherapy, Medical Center – University of Freiburg, Faculty of Medicine, University of Freiburg, Germany Contact name: Prof. Dr. med. Ludger Tebartz van Elst Address: Medical Center – University of Freiburg, Department of Psychiatry and Psychotherapy, Hauptstrasse 5, 79104 Freiburg, Germany E-Mail: tebartzvanelst@uniklinik-freiburg.de |
Role of sponsor {5c} | The reviewers of the German Research Foundation had impact on the original study design. Per request of the reviewers, randomization has been changed from 4:3:3 (FASTER : SCOTT&EVA : TAU) to 1:1:1, resulting in a higher sample size than initially intended. Further, reviewers requested the Social Responsiveness Scale (external assessment) as primary outcome measure. |