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FASTER 和 SCOTT&EVA 训练计划用于高功能自闭症谱系障碍(ASD)成人:一项随机对照试验的研究方案。

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

机构信息

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.

出版信息

Trials. 2021 Apr 8;22(1):261. doi: 10.1186/s13063-021-05205-9.

Abstract

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

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

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

German Clinical Trial Register DRKS00017817 . Registered on 20 April 2020.

摘要

背景

自闭症谱系障碍(ASD)是一种常见的神经发育障碍,患病率超过 1%,其特征是社交沟通和互动方面存在缺陷;行为、兴趣或活动受限、重复;以及对常规和例行程序的偏好。大多数成年 ASD 患者患有共病,如抑郁和焦虑。成人 ASD 患者的治疗选择有限,目前德国尚无循证干预措施。最近,有两项改善社交反应的干预措施已经发表。FASTER(“Freiburger Asperger-Spezifische Therapie für ERwachsene”=弗赖堡成人特定的治疗自闭症)是一个包括三个模块的团体心理治疗方案,分别是心理教育、压力调节管理和非言语和言语社交沟通训练,使用录像任务。SCOTT&EVA(“Social Cognition Training Tool”,及其增强版“Emotionen Verstehen und Ausdruecken”=理解和表达情感)是一个基于计算机的训练程序,旨在增强社会认知,包括情感表达和复杂现实社会情境的视频和音频材料。这两个方案的初步研究都显示出良好的可行性和疗效。

方法

360 名成年自闭症谱系障碍(ASD)患者将参加一项随机对照三臂多中心试验,以证明团体心理治疗和基于计算机的培训方案的有效性。这两种干预措施将与常规治疗(TAU)组进行比较,旨在为成年 ASD 患者建立基于证据的心理治疗方法。主要结局由对各自参与者的社交沟通和互动有足够了解的父母、配偶或其他人评估,并用社交反应量表测量。首先,将每种干预措施与 TAU 进行比较。如果至少有一个差异有统计学意义,则将两种干预措施相互比较。主要结局将在基线(T0)和基线后 4 个月(T1)测量。

讨论

该试验是首次在德国验证针对成年 ASD 患者的精神病治疗和培训干预措施。由于成年期无智力障碍的 ASD 患病率较高,且德国尚无基于证据的干预措施,因此需要进行试验。

试验注册

德国临床试验注册处 DRKS00017817。注册于 2020 年 4 月 20 日。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/aaf1/8034078/74200c41f382/13063_2021_5205_Fig1_HTML.jpg

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