title: 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.
abstract: BACKGROUND
  Group-based social skills training (SST) has repeatedly been recommended as treatment of choice in high-functioning autism spectrum disorder (HFASD). To date, no sufficiently powered randomised controlled trial has been performed to establish efficacy and safety of SST in children and adolescents with HFASD. In this randomised, multi-centre, controlled trial with 220 children and adolescents with HFASD it is hypothesized, that add-on group-based SST using the 12 weeks manualised SOSTA-FRA program will result in improved social responsiveness (measured by the parent rated social responsiveness scale, SRS) compared to treatment as usual (TAU). It is further expected, that parent and self reported anxiety and depressive symptoms will decline and pro-social behaviour will increase in the treatment group. A neurophysiological study in the Frankfurt HFASD subgroup will be performed pre- and post treatment to assess changes in neural function induced by SST versus TAU.
  
  
  METHODS
  The SOSTA - net trial is designed as a prospective, randomised, multi-centre, controlled trial with two parallel groups. The primary outcome is change in SRS score directly after the intervention and at 3 months follow-up. Several secondary outcome measures are also obtained. The target sample consists of 220 individuals with ASD, included at the six study centres.
  
  
  CONCLUSIONS
  This study is currently one of the largest trials on SST in children and adolescents with HFASD worldwide. Compared to recent randomised controlled studies, our study shows several advantages with regard to in- and exclusion criteria, study methods, and the therapeutic approach chosen, which can be easily implemented in non-university-based clinical settings.
  
  
  BACKGROUND
  ISRCTN94863788--SOSTA--net: Group-based social skills training in children and adolescents with high functioning autism spectrum disorder.
authors.affiliation: Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University of Frankfurt, 60528 Frankfurt, Germany. C.Freitag@em.uni-frankfurt.de
authors.forename: Christine M
authors.initials: CM
authors.lastname: Freitag
authors.forename: Hannah
authors.initials: H
authors.lastname: Cholemkery
authors.forename: Leyla
authors.initials: L
authors.lastname: Elsuni
authors.forename: Anne K
authors.initials: AK
authors.lastname: Kroeger
authors.forename: Stephan
authors.initials: S
authors.lastname: Bender
authors.forename: Cornelia Ursula
authors.initials: CU
authors.lastname: Kunz
authors.forename: Meinhard
authors.initials: M
authors.lastname: Kieser
mesh_terms: D000223:Adaptation, Psychological; D000293:Adolescent; D002648:Child; D002659:Child Development Disorders, Pervasive / Q000523:psychology* / Q000628:therapy*; D003142:Communication; D005260:Female; D006801:Humans; D008297:Male; D011446:Prospective Studies; D000297:Psychology, Adolescent; D002666:Psychology, Child; D012919:Social Behavior