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

Primary Purpose

Autism Spectrum Disorder (ASD), Attention Deficit Hyperactivity Disorder (ADHD), Anxiety

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Social skills group training, KONTAKT
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder (ASD) focused on measuring Autism spectrum disorder, Social skills training, Group training, Comorbidity, Intervention, Evidence-based

Eligibility Criteria

8 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Child & Adolescent Psychiatry Research Center, KIND

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Social skills group training KONTAKT

Control group (TAU), the usual intervention / treatment

Arm Description

N= 144 participants are offered group training KONTAKT. The intervention includes 12 (brief intervention) and 24 (long intervention) sessions.

N = 144 participants are received treatment as usual (pharmacological therapy, family therapy, Cognitive behavioral therapy etc).

Outcomes

Primary Outcome Measures

Social Responsiveness Scale (SRS)
Parent and teachers report.

Secondary Outcome Measures

Adaptive Behavior Assessment System II (ABAS II)
Parent and teachers report.
Developmental Disabilities Modification of the Children's Global Assessment Scale (DD-CGAS)
Experts report.
Clinical Global Impression-Improvement/Severity (CGI)
Experts report.
Samples With DNA
Genetic material via saliva-kit will be collected.

Full Information

First Posted
April 20, 2013
Last Updated
August 18, 2017
Sponsor
Karolinska Institutet
Collaborators
Child and Adolescent Psychiatry, Stockholm, Region Stockholm, Stiftelsen Sunnerdahls Handikappfond, The Swedish Research Council, The Pediatric Research Foundation at Astrid Lindgren Children's Hospital, Majblomman
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1. Study Identification

Unique Protocol Identification Number
NCT01854346
Brief Title
Social Skills Group Training ("KONTAKT") for Children and Adolescent With High-functioning Autism Spectrum Disorders
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Child and Adolescent Psychiatry, Stockholm, Region Stockholm, Stiftelsen Sunnerdahls Handikappfond, The Swedish Research Council, The Pediatric Research Foundation at Astrid Lindgren Children's Hospital, Majblomman

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder (ASD), Attention Deficit Hyperactivity Disorder (ADHD), Anxiety, Depression
Keywords
Autism spectrum disorder, Social skills training, Group training, Comorbidity, Intervention, Evidence-based

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
296 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Social skills group training KONTAKT
Arm Type
Experimental
Arm Description
N= 144 participants are offered group training KONTAKT. The intervention includes 12 (brief intervention) and 24 (long intervention) sessions.
Arm Title
Control group (TAU), the usual intervention / treatment
Arm Type
No Intervention
Arm Description
N = 144 participants are received treatment as usual (pharmacological therapy, family therapy, Cognitive behavioral therapy etc).
Intervention Type
Behavioral
Intervention Name(s)
Social skills group training, KONTAKT
Other Intervention Name(s)
Social skills training, Social skills group training, KONTAKT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Social Responsiveness Scale (SRS)
Description
Parent and teachers report.
Time Frame
Baseline, 3 months after training and 3 months follow-up
Secondary Outcome Measure Information:
Title
Adaptive Behavior Assessment System II (ABAS II)
Description
Parent and teachers report.
Time Frame
Baseline, 3 months after training and 3 months follow-up
Title
Developmental Disabilities Modification of the Children's Global Assessment Scale (DD-CGAS)
Description
Experts report.
Time Frame
Baseline, 3 months after training and 3 months follow-up
Title
Clinical Global Impression-Improvement/Severity (CGI)
Description
Experts report.
Time Frame
Baseline, 3 months after training and 3 months follow-up
Title
Samples With DNA
Description
Genetic material via saliva-kit will be collected.
Time Frame
2 weeks after the beginning of the treatment
Other Pre-specified Outcome Measures:
Title
Perceived stress Scale (PSS)
Description
Parent report.
Time Frame
Baseline, 3 months after training and 3 months follow-up
Title
Barn Under Stress (BUS)
Description
Self report.
Time Frame
Baseline, 3 months after training and 3 months follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sven Bölte, PhD, Professor
Organizational Affiliation
Karolinska Institutet, Center of Neurodevelopmental Disorders (KIND)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Child & Adolescent Psychiatry Research Center, KIND
City
Stockholm
ZIP/Postal Code
11330
Country
Sweden

12. IPD Sharing Statement

Citations:
Citation
1. Reichow B, Steiner A. M., Volkmar FR. Social skills groups for people aged 6 to 21 with autism spectrum disorders (ASD) (Review). Cochrane Developmental, Psychosocial and Learning Problems Group, 2012. DOI: 10.1002/14651858.
Results Reference
background
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.
Results Reference
background
PubMed Identifier
19165532
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.
Results Reference
background
PubMed Identifier
24379174
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.
Results Reference
background
PubMed Identifier
28647010
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.
Results Reference
background
PubMed Identifier
26912485
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.
Results Reference
derived
Links:
URL
http://www.ki.se/kind
Description
Homepage KIND

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

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