Clinical trial NCT01854346: Social Skills Group Training ("KONTAKT") for Children and Adolescent With High-functioning Autism Spectrum Disorders
Official title: Genotype and Behavioral Effects of Social Skills Training in Children and Adolescents With High-functioning Autism Spectrum Disorders, a Randomized Controlled Trial (RCT) and Multicenter Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder (ASD)
Attention Deficit Hyperactivity Disorder (ADHD)
Anxiety
Depression
Keywords: Autism spectrum disorder
Social skills training
Group training
Comorbidity
Intervention
Evidence-based
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Child and Adolescent Psychiatry, Stockholm
name: Region Stockholm
name: Stiftelsen Sunnerdahls Handikappfond
name: The Swedish Research Council
name: The Pediatric Research Foundation at Astrid Lindgren Children's Hospital
name: Majblomman
First posted: 2013-05-15
Enrollment: 296
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial investigates the behavioral effects of manualized social skills training (KONTAKT) in children´s and adolescents with high-functioning autism spectrum disorder with psychiatric comorbidity in a RCT, multicenter study. N = 288 are recruited from 10 child and adolescent psychiatric clinics in Stockholm County. The examination of genetic variants as predictors for outcome and a qualitative study of KONTAKT complete the trial.

Detailed description: There are few randomized controlled trials of social skills group training for the Children's and adolescents with high functioning autism spectrum disorders (HFA)(1). The Objective of this trial is to investigate the behavioral effects of the manualized social skills group training KONTAKT (2,3) and the role of genetic variants for training effects.

Eligibility criteria: Inclusion criteria:

* Children and adolescent with High-functioning autism (F84.5, F 84.9 according to International Classification of Diseases (ICD-10). Participants have been investigated with the Autism Diagnostic Observation Schedule (ADOS).
* Normal psychometric range of intelligence, intelligence quotient (IQ)\> 70 according to Wechsler Intelligence Scale for Children- Fourth Edition (WISC-IV).
* Comorbid diagnosis: ADHD (F90.0 and F98.8), Anxiety Syndrome (F41.1) and depression (F32.9) according to a best estimate clinical assessment.

Exclusion criteria:

Any behavioral disorder not currently allowing meaningful participation in group-based training for ASD, e.g. presence of clinically diagnosed self-injury, conduct disorder (F91), hyperkinetic conduct disorder (F90.1), antisocial personality disorder (F60.2), borderline personality disorder (F60.3) or any form of schizophrenia or related psychotic disorder (F20-F29).

Primary outcomes:
measure: Social Responsiveness Scale (SRS)
timeFrame: Baseline, 3 months after training and 3 months follow-up
Secondary outcomes:
measure: Adaptive Behavior Assessment System II (ABAS II)
timeFrame: Baseline, 3 months after training and 3 months follow-up
measure: Developmental Disabilities Modification of the Children's Global Assessment Scale (DD-CGAS)
timeFrame: Baseline, 3 months after training and 3 months follow-up
measure: Clinical Global Impression-Improvement/Severity (CGI)
timeFrame: Baseline, 3 months after training and 3 months follow-up
measure: Samples With DNA
timeFrame: 2 weeks after the beginning of the treatment
Other outcomes:
measure: Perceived stress Scale (PSS)
timeFrame: Baseline, 3 months after training and 3 months follow-up
measure: Barn Under Stress (BUS)
timeFrame: Baseline, 3 months after training and 3 months follow-up
Locations:
city: Stockholm
country: Sweden
facility: Child & Adolescent Psychiatry Research Center, KIND
Study officials:
affiliation: Karolinska Institutet, Center of Neurodevelopmental Disorders (KIND)
name: Sven Bölte, PhD, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Reichow B, Steiner AM, Volkmar F. Social skills groups for people aged 6 to 21 with autism spectrum disorders (ASD). Cochrane Database Syst Rev. 2012 Jul 11;2012(7):CD008511. doi: 10.1002/14651858.CD008511.pub2.
citation: 2. Bölte S., Choque-Olsson N., Swedish version, KONTAKT, Social färdighetsträning i grupp med fokus på kommunikation och social interaktion vid autismspektrumtillstånd enligt Frankfurtmodellen. Hogrefe, 2011.
citation: Herbrecht E, Poustka F, Birnkammer S, Duketis E, Schlitt S, Schmotzer G, Bolte S. Pilot evaluation of the Frankfurt Social Skills Training for children and adolescents with autism spectrum disorder. Eur Child Adolesc Psychiatry. 2009 Jun;18(6):327-35. doi: 10.1007/s00787-008-0734-4. Epub 2009 Jan 22.
citation: Choque Olsson N, Bolte S. Brief report: "Quick and (not so) dirty" assessment of change in autism: cross-cultural reliability of the Developmental Disabilities CGAS and the OSU autism CGI. J Autism Dev Disord. 2014 Jul;44(7):1773-8. doi: 10.1007/s10803-013-2029-y.
citation: Choque Olsson N, Flygare O, Coco C, Gorling A, Rade A, Chen Q, Lindstedt K, Berggren S, Serlachius E, Jonsson U, Tammimies K, Kjellin L, Bolte S. Social Skills Training for Children and Adolescents With Autism Spectrum Disorder: A Randomized Controlled Trial. J Am Acad Child Adolesc Psychiatry. 2017 Jul;56(7):585-592. doi: 10.1016/j.jaac.2017.05.001. Epub 2017 May 10.
citation: Choque Olsson N, Rautio D, Asztalos J, Stoetzer U, Bolte S. Social skills group training in high-functioning autism: A qualitative responder study. Autism. 2016 Nov;20(8):995-1010. doi: 10.1177/1362361315621885. Epub 2016 Feb 24.