Three-arm, cluster-randomized controlled study to assess the effects of FASTER and SCOTT trainings for adults with high-functioning autism spectrum disorder (ASD)

Phase 3

Recruiting

Conditions: F84.1
F84.5
F84.0
Atypical autism
Childhood autism
Asperger syndrome

Registration Number: DRKS00017817

Lead Sponsor: Klinik für Psychiatrie und PsychotherapieUniversitätsklinikum FreiburgMedizinische Fakultät

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 360

Inclusion Criteria

(+) Diagnosis of autism or Asperger syndrome, high-functioning (ICD-10: F84.0, F84.5 or F84.1 if DSM criterion A, social communication and social interaction is true)
(+) Age between 18 and 65
(+) IQ at least 80
(+) Relevant psychosocial impairment [global assessment of function (GAF) score = 60]
(+) Fluent German language of patient and parent / spouse / other close person to enable filling out of questionnaires and understanding instructions
(+) Ability of subject to understand character and individual consequences of clinical trial
(+) Written informed consent
(+) No severe reading or writing disability
(+) none, or stable psychopharmacotherapy
(+) Existence of one person for external assessment (SRS-A, parent/ spouse/ other)

Exclusion Criteria

(-) Psychiatric comorbidities: acute (florid) psychosis, acute (florid) schizophrenia, acute bipolar disorder, acute severe depression, acute suicidality
(-) substance abuse/ substance dependecies within the last 12 months
(-) Present or past gambling disorder
(-) Not corrected severe vision or hearing impairment
(-) A history of severe group disturbing behaviour
(-) Any neurological disorder or medical condition interfering with group therapy
(-) Group-based social skills training or other structured psychotherapy for the core symptoms of ASD (current or in the last 6 months prior tot he study, structured psychotherapy for comorbid disorders are allowed)
(-) inpatient treatment at T0

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
SRS-A external assessment, difference four months after randomization, after four month therapy with 16 sessions

Secondary Outcome Measures

Name	Time	Method
(1a) Difference of change of STS-A scores between FASTER and SCOTT&EVA. <br>(1b) Difference of change of SRS-A self-report total sum score <br>(1c) Differences of change of SRS-A external assessment and self-report for the five subscores <br>(1d) Differences of change of SRS-A modified for the total score and the five subscores (self-report and external assessment)<br><br>(2) Changes in social cognition [MET]<br><br>General psychiatric well-being <br>[(3) depression: BDI-II, (4) global functioning: GAF, (5) social anxiety and social skills deficit: SASKO]<br><br>(6) Quality of life [WHOQoL-BREF], <br><br>(7) self-esteem [MSWS] and <br><br>(8) life satisfaction [FLZ] <br><br>(9) Partnership questionnaire, if appropriate