Condition category
Mental and Behavioural Disorders
Date applied
17/06/2010
Date assigned
12/08/2010
Last edited
04/01/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Dr. med. Dipl. theol. Christine Freitag

ORCID ID

Contact details

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

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

http://www.dfg.de/

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

  1. 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.

  2. 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.

Additional files

Editorial Notes