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
Scientific
Klinik für Psychiatrie, Psychosomatik und Psychotherapie des Kindes- und Jugendalters der Goethe-Universität
Deutschordenstraße 50
Frankfurt am Main
60528
Germany
Study information
| Study design | Prospective randomised multicentre controlled parallel-group design |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 07/05/2010 |
| Completion date | 07/03/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Both |
| Target number of participants | N = 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
60528
Germany
Sponsor information
German Research Council (Deutsche Forschungsgemeinschaft [DFG]) (Germany)
Research council
Research council
Lebenswissenschaften 1
Geschaftsstelle
Kennedyallee 40
Bonn
53170
Germany
| Website | http://www.dfg.de/ |
|---|---|
"ROR" |
https://ror.org/018mejw64 |
Funders
Funder type
Research council
Deutsche Forschungsgemeinschaft
Government organisation / National government
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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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 |
