Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Version 1: 01032010
Study information
Scientific title
Randomised multicentre controlled trial of group-based social skills training in children and adolescents with high functioning autism spectrum disorder (SOSTA-Net)
Acronym
SOSTA net
Study hypothesis
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
Ethikkommission des Fachbereichs Medizin der Johann Wolfgang Goethe-Universität Frankfurt am Main, 30/03/2010, ref: 57/10
Study design
Prospective randomised multicentre controlled parallel-group design
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Drug names
Primary outcome measures
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
Secondary outcome measures
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
Overall trial start date
07/05/2010
Overall trial end date
07/03/2013
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
N = 220
Participant 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
Recruitment start date
07/05/2010
Recruitment end date
07/03/2013
Locations
Countries of recruitment
Germany
Trial participating centre
Klinik für Psychiatrie, Psychosomatik und Psychotherapie des Kindes- und Jugendalters der Goethe-Universität
Frankfurt am Main
60528
Germany
Sponsor information
Organisation
German Research Council (Deutsche Forschungsgemeinschaft [DFG]) (Germany)
Sponsor details
Lebenswissenschaften 1
Geschaftsstelle
Kennedyallee 40
Bonn
53170
Germany
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Deutsche Forschungsgemeinschaft
Alternative name(s)
German Research Foundation, DFG
Funding Body Type
private sector organisation
Funding Body Subtype
foundation
Location
Germany
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2013 protocol in http://www.ncbi.nlm.nih.gov/pubmed/23289935
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26715086
Publication citations
-
Protocol
Freitag CM, Cholemkery H, Elsuni L, Kroeger AK, Bender S, Kunz CU, Kieser M, The group-based social skills training SOSTA-FRA in children and adolescents with high functioning autism spectrum disorder--study protocol of the randomised, multi-centre controlled SOSTA--net trial., Trials, 2013, 14, 6, doi: 10.1186/1745-6215-14-6.
-
Results
Freitag CM, Jensen K, Elsuni L, Sachse M, Herpertz-Dahlmann B, Schulte-Rüther M, Hänig S, von Gontard A, Poustka L, Schad-Hansjosten T, Wenzl C, Sinzig J, Taurines R, Geißler J, Kieser M, Cholemkery H, Group-based cognitive behavioural psychotherapy for children and adolescents with ASD: the randomized, multicentre, controlled SOSTA - net trial, J Child Psychol Psychiatry, 2015, doi: 10.1111/jcpp.12509.