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
Secondary identifying numbers Version 1: 01032010
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

Study designProspective randomised multicentre controlled parallel-group design
Primary study designInterventional
Secondary study designRandomised parallel trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleRandomised multicentre controlled trial of group-based social skills training in children and adolescents with high functioning autism spectrum disorder (SOSTA-Net)
Study acronymSOSTA net
Study objectivesTo 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) studiedAutism spectrum disorder (high functioning)
Intervention1. 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 typeBehavioural
Primary outcome measureChange 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
Secondary outcome measuresMeasured 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
Overall study start date07/05/2010
Completion date07/03/2013

Eligibility

Participant type(s)Patient
Age groupOther
SexBoth
Target number of participantsN = 220
Key inclusion criteria1. 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 criteria1. 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 enrolment07/05/2010
Date of final enrolment07/03/2013

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

Sponsor information

German Research Council (Deutsche Forschungsgemeinschaft [DFG]) (Germany)
Research council

Lebenswissenschaften 1
Geschaftsstelle
Kennedyallee 40
Bonn
53170
Germany

Website http://www.dfg.de/
ROR logo "ROR" https://ror.org/018mejw64

Funders

Funder type

Research council

Deutsche Forschungsgemeinschaft
Government organisation / National government
Alternative name(s)
German Research Association, German Research Foundation, DFG
Location
Germany

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

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