Social Skills Group Training ("KONTAKT") for Children and Adolescent With High-functioning Autism Spectrum Disorders

Depression Clinical Trial

— KONTAKT-RCT  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01854346
• Other study ID #: KONTAKT
• Status: Completed
• Phase: N/A
• First received: April 20, 2013
• Last updated: August 18, 2017
• Start date: August 2012
• Est. completion date: March 2016

Study information

• Verified date: August 2017
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 296
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 17 Years

Eligibility

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).

Related Conditions & MeSH terms

• Anxiety
• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder (ADHD)
• Autism Spectrum Disorder
• Autism Spectrum Disorder (ASD)
• Autistic Disorder
• Child Development Disorders, Pervasive
• Depression
• Disease

Intervention

Behavioral:
• Social skills group training, KONTAKT
KONTAKT is a manual-based social skills group training for children with high functioning autism spectrum disorder (ASD). The program is based on cognitive behavioral therapy (CBT) principles and knowledge of social cognition. The group treatment includes exercises in social skills as well as discussions of social cognition, social interaction, self-reflection and description of themselves and others. The children are training to make contact, to understand and follow social rules, to become aware of themselves and others, to perceive verbal and nonverbal signals in a communication, to develop problem solving skills and coping strategies to manage conflict and to enhance their self-confidence. Intervention includes 12 (brief intervention) and 24 (long intervention) sessions. Each group consists of 4-8 children/adolescents ant two group leaders. The treatment are conducted in cooperation with both parents and teachers.

Locations

Country	Name	City	State
Sweden	Child & Adolescent Psychiatry Research Center, KIND	Stockholm

Sponsors (7)

Lead Sponsor	Collaborator
Karolinska Institutet	Child and Adolescent Psychiatry, Stockholm, Majblomman, Stiftelsen Sunnerdahls Handikappfond, Stockholm County Council, Sweden, The Pediatric Research Foundation at Astrid Lindgren Children's Hospital, The Swedish Research Council

Country where clinical trial is conducted

Sweden, 

References & Publications (5)

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.

Choque Olsson N, Bölte 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. — View Citation

Choque Olsson N, Flygare O, Coco C, Görling A, Råde A, Chen Q, Lindstedt K, Berggren S, Serlachius E, Jonsson U, Tammimies K, Kjellin L, Bölte 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. — View Citation

Herbrecht E, Poustka F, Birnkammer S, Duketis E, Schlitt S, Schmötzer G, Bölte 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. — View 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;(7):CD008511. doi: 10.1002/14651858.CD008511.pub2. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Perceived stress Scale (PSS)	Parent report.	Baseline, 3 months after training and 3 months follow-up
Other	Barn Under Stress (BUS)	Self report.	Baseline, 3 months after training and 3 months follow-up
Primary	Social Responsiveness Scale (SRS)	Parent and teachers report.	Baseline, 3 months after training and 3 months follow-up
Secondary	Adaptive Behavior Assessment System II (ABAS II)	Parent and teachers report.	Baseline, 3 months after training and 3 months follow-up
Secondary	Developmental Disabilities Modification of the Children's Global Assessment Scale (DD-CGAS)	Experts report.	Baseline, 3 months after training and 3 months follow-up
Secondary	Clinical Global Impression-Improvement/Severity (CGI)	Experts report.	Baseline, 3 months after training and 3 months follow-up
Secondary	Samples With DNA	Genetic material via saliva-kit will be collected.	2 weeks after the beginning of the treatment

External Links

•   Homepage KIND
•   KONTAKT- study homepage (Swedish only)