FASTER and SCOTT&EVA trainings for adults with high-functioning autism spectrum disorder (ASD): study protocol for a randomized controlled trial.

Adults Autism spectrum disorder High-functioning autism Internet-based training Psychotherapy Randomized controlled trial Social cognition training Social skills intervention

Journal

Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253

Informations de publication

Date de publication:
08 Apr 2021
Historique:
received: 29 12 2020
accepted: 18 03 2021
entrez: 9 4 2021
pubmed: 10 4 2021
medline: 22 6 2021
Statut: epublish

Résumé

Autism spectrum disorder (ASD) is a chronic neurodevelopmental condition with a prevalence rate above 1%, characterized by deficits in social communication and interaction; restrictive, repetitive patterns of behavior, interests, or activities; and a preference for sameness and routines. The majority of adult ASD patients suffer from comorbid conditions such as depression and anxiety. Therapy options for adult ASD patients are lacking, with presently no available evidence-based interventions in Germany. Recently, two interventions to improve social responsiveness have been published. FASTER ("Freiburger Asperger-Spezifische Therapie für ERwachsene" = Freiburg Asperger-specific therapy for adults) is a manualized group psychotherapy program including three modules on psychoeducation, stress regulation management, and non-verbal and verbal social communication training with videotaped tasks. SCOTT&EVA ("Social Cognition Training Tool", and its enhancement "Emotionen Verstehen und Ausdruecken" = understanding and expressing emotions) is a computer-based training program to enhance social cognition including video and audio material of emotional expressions and complex real-life social situations. Initial studies for both programs have shown good feasibility and efficacy. Three hundred sixty adult participants with an autism spectrum disorder (ASD) will take part in a randomized controlled three-armed multi-center trial to prove the efficacy of manualized group psychotherapy and a manualized computer-based training program. Both interventions will be compared with a treatment as usual (TAU) group, aiming to establish evidence-based psychotherapy approaches for adult individuals with ASD. The primary outcome is evaluated by parents, spouses, or others who have sufficient insight into the respective participant's social communication and interaction, and will be measured with the Social Responsiveness Scale. First, each of both interventions will be compared to TAU. If at least one of the differences is significant, both interventions will be compared against each other. The primary outcome will be measured at baseline (T0) and 4 months after baseline (T1). The trial is the first to validate psychiatric therapeutic and training interventions for adult ASD patients in Germany. A trial is needed because the prevalence of ASD in adulthood without intellectual disability is high, and no evidence-based intervention can be offered in Germany. German Clinical Trial Register DRKS00017817 . Registered on 20 April 2020.

Sections du résumé

BACKGROUND BACKGROUND
Autism spectrum disorder (ASD) is a chronic neurodevelopmental condition with a prevalence rate above 1%, characterized by deficits in social communication and interaction; restrictive, repetitive patterns of behavior, interests, or activities; and a preference for sameness and routines. The majority of adult ASD patients suffer from comorbid conditions such as depression and anxiety. Therapy options for adult ASD patients are lacking, with presently no available evidence-based interventions in Germany. Recently, two interventions to improve social responsiveness have been published. FASTER ("Freiburger Asperger-Spezifische Therapie für ERwachsene" = Freiburg Asperger-specific therapy for adults) is a manualized group psychotherapy program including three modules on psychoeducation, stress regulation management, and non-verbal and verbal social communication training with videotaped tasks. SCOTT&EVA ("Social Cognition Training Tool", and its enhancement "Emotionen Verstehen und Ausdruecken" = understanding and expressing emotions) is a computer-based training program to enhance social cognition including video and audio material of emotional expressions and complex real-life social situations. Initial studies for both programs have shown good feasibility and efficacy.
METHODS METHODS
Three hundred sixty adult participants with an autism spectrum disorder (ASD) will take part in a randomized controlled three-armed multi-center trial to prove the efficacy of manualized group psychotherapy and a manualized computer-based training program. Both interventions will be compared with a treatment as usual (TAU) group, aiming to establish evidence-based psychotherapy approaches for adult individuals with ASD. The primary outcome is evaluated by parents, spouses, or others who have sufficient insight into the respective participant's social communication and interaction, and will be measured with the Social Responsiveness Scale. First, each of both interventions will be compared to TAU. If at least one of the differences is significant, both interventions will be compared against each other. The primary outcome will be measured at baseline (T0) and 4 months after baseline (T1).
DISCUSSION CONCLUSIONS
The trial is the first to validate psychiatric therapeutic and training interventions for adult ASD patients in Germany. A trial is needed because the prevalence of ASD in adulthood without intellectual disability is high, and no evidence-based intervention can be offered in Germany.
TRIAL REGISTRATION BACKGROUND
German Clinical Trial Register DRKS00017817 . Registered on 20 April 2020.

Identifiants

pubmed: 33832537
doi: 10.1186/s13063-021-05205-9
pii: 10.1186/s13063-021-05205-9
pmc: PMC8028579
doi:

Types de publication

Clinical Trial Protocol Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

261

Subventions

Organisme : Deutsche Forschungsgemeinschaft
ID : DFG TE 280/18-1

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Auteurs

Ludger Tebartz van Elst (L)

Department of Psychiatry and Psychotherapy Medical Center, University of Freiburg Faculty of Medicine, Freiburg im Breisgau, Germany. tebartzvanelst@uniklinik-freiburg.de.

Thomas Fangmeier (T)

Department of Psychiatry and Psychotherapy Medical Center, University of Freiburg Faculty of Medicine, Freiburg im Breisgau, Germany.

Ulrich Max Schaller (UM)

Department of Psychiatry and Psychotherapy Medical Center, University of Freiburg Faculty of Medicine, Freiburg im Breisgau, Germany.
Department of Child and Adolescent Psychiatry, Psychotherapy, and Psychosomatics, Medical Center, University of Freiburg Faculty of Medicine, Freiburg im Breisgau, Germany.

Oliver Hennig (O)

Central Institute for Mental Health, Mannheim, Germany.

Meinhard Kieser (M)

Institute of Medical Biometry and Informatics, University Hospital Heidelberg, Heidelberg, Germany.

Katja Koelkebeck (K)

Department of Psychiatry and Psychotherapy, LVR-Hospital Essen, Medical Faculty, University of Duisburg-Essen, Duisburg, Germany.

Charlotte Kuepper (C)

Department of Psychology, Berlin School of Mind and Brain, Humboldt-Universitaet zu Berlin, Berlin, Germany.

Veit Roessner (V)

Department of Child and Adolescent Psychiatry and Psychotherapy, Faculty of Medicine, TU Dresden, Dresden, Germany.

Dirk Wildgruber (D)

Department of Psychiatry and Psychotherapy, University of Tuebingen, Tübingen, Germany.

Isabel Dziobek (I)

Department of Psychology, Berlin School of Mind and Brain, Humboldt-Universitaet zu Berlin, Berlin, Germany.

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Classifications MeSH