SOSTA net: Group-based social skills training in children and adolescents with high functioning autism spectrum disorder

ISRCTN	ISRCTN94863788
DOI	https://doi.org/10.1186/ISRCTN94863788
Protocol serial number	Version 1: 01032010
Sponsor	German Research Council (Deutsche Forschungsgemeinschaft [DFG]) (Germany)
Funder	Deutsche Forschungsgemeinschaft

Submission date: 17/06/2010
Registration date: 12/08/2010
Last edited: 04/01/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Dr. med. Dipl. theol. Christine Freitag
Scientific

Klinik für Psychiatrie, Psychosomatik und Psychotherapie des Kindes- und Jugendalters der Goethe-Universität
Deutschordenstraße 50
Frankfurt am Main
60528
Germany

Study information

Primary study design	Interventional
Study design	Prospective randomised multicentre controlled parallel-group design
Secondary study design	Randomised parallel trial
Study type	Participant information sheet
Scientific title	Randomised multicentre controlled trial of group-based social skills training in children and adolescents with high functioning autism spectrum disorder (SOSTA-Net)
Study acronym	SOSTA net
Study objectives	To establish efficacy of group-based social skills training (SST) in children and adolescents with high functioning autism spectrum disorder (HFASD). It is hypothesised that add-on group-based SST using a manualised therapy-program will result in improved social responsiveness compared to treatment as usual (TAU), including no treatment (waiting list). In addition, a neurophysiological substudy in the Frankfurt subgroup (N = 60) will be performed pre- and post-treatment to explore changes in neuronal function induced by SST versus TAU. It is further expected that specific functional genetic variants will mediate treatment outcome. Functional genetic variants will be assessed in all participants.
Ethics approval(s)	Ethikkommission des Fachbereichs Medizin der Johann Wolfgang Goethe-Universität Frankfurt am Main, 30/03/2010, ref: 57/10
Health condition(s) or problem(s) studied	Autism spectrum disorder (high functioning)
Intervention	1. Experimental intervention: 1.1. Weekly group-based manualised, social skills training of 12 sessions 1.2. 3 x parent training 1.3. Add-on therapy to treatment as usual (TAU) 2. Control intervention: 2.1. Treatment as usual (TAU), including waiting list, excluding group-based therapy 2.2. 3 x parent training Follow-up per patient: three months Duration of intervention per patient: Experimental intervention: 12 x 90 minutes plus 3 x parent training Control intervertion: 3 x parent training; TAU without group therapy or waiting list
Intervention type	Behavioural
Primary outcome measure(s)	Change in total raw score of the Social Responsiveness Scale (SRS) as assessed by the primary caretaker (PC), measured: 1. Between baseline and end of intervention 2. Between baseline and 3 months after end of intervention
Key secondary outcome measure(s)	Measured 0 and 3 months after end of intervention: 1. Response to intervention: Individual symptom reduction of at least 16 raw points in SRS total score (PC and teacher [T] assessment) 2. Change in SRS total raw score (T) 3. Change in SRS subscale raw scores (PC, T) 4. Change in anxious-depressive symptoms (CBCL:PC) 5. Change in total psychopathology, pro-social behaviour, and peer related problems (SDQ: PC, T) 6. Change in depressive symptoms (DIKJ, self assessment) 7. Motivation and satisfaction with therapy (self assessment) 8. Change in neuronal function during cognitive and affective empathy tasks 9. Assessment of genetic variants and medication as possible mediating variables of therapeutic effect 10. Assessment of safety: serious adverse and adverse events will be documented
Completion date	07/03/2013

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	All
Target sample size at registration	220
Key inclusion criteria	1. High-functioning autism (F84.0) 2. Asperger syndrome (F84.5) 3. Atypical autism (F84.1) 4. Aged 8 - 20 years, either sex 5. Informed consent 6. No or stable psychopharmacotherapy
Key exclusion criteria	1. Intelligence quotient (IQ) less than 70 2. Schizophrenia 3. Social phobia 4. Obsessive-compulsive disorder 5. Major depressive episode with suicidal ideation 6. Aggressive behaviour interfering with group therapy 7. Any personality disorder 8. Neurological disorder (exception: well treated epilepsy) 9. Other medical disorder interfering with therapy 10. Group-based SST during last 6 months prior to study
Date of first enrolment	07/05/2010
Date of final enrolment	07/03/2013

Locations

Countries of recruitment

Germany

Study participating centre

Klinik für Psychiatrie, Psychosomatik und Psychotherapie des Kindes- und Jugendalters der Goethe-Universität

Frankfurt am Main
60528
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2016		Yes	No
Protocol article	protocol	07/01/2013		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes