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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2015 by Karolinska Institutet
Sponsor:
Collaborators:
Child and Adolescent Psychiatry (BUP), Stockholm
Stockholm County Council, Sweden
Stiftelsen Sunnerdahls Handikappfond
Swedish Science Council
Barnforskningen: ALB
Majblomman
Information provided by (Responsible Party):
Sven Bölte, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01854346
First received: April 20, 2013
Last updated: May 6, 2015
Last verified: May 2015
  Purpose

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.


Condition Intervention
Autism Spectrum Disorder (ASD)
Attention Deficit Hyperactivity Disorder (ADHD)
Anxiety
Depression
Behavioral: Social skills group training, KONTAKT

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Social Responsiveness Scale (SRS) [ Time Frame: Baseline, 3 months after training and 3 months follow-up ] [ Designated as safety issue: No ]
    Parent and teachers report.


Secondary Outcome Measures:
  • Adaptive Behavior Assessment System II (ABAS II) [ Time Frame: Baseline, 3 months after training and 3 months follow-up ] [ Designated as safety issue: No ]
    Parent and teachers report.

  • Developmental Disabilities Modification of the Children's Global Assessment Scale (DD-CGAS) [ Time Frame: Baseline, 3 months after training and 3 months follow-up ] [ Designated as safety issue: No ]
    Experts report.

  • Clinical Global Impression-Improvement/Severity (CGI) [ Time Frame: Baseline, 3 months after training and 3 months follow-up ] [ Designated as safety issue: No ]
    Experts report.

  • Samples With DNA [ Time Frame: 2 weeks after the beginning of the treatment ] [ Designated as safety issue: No ]
    Genetic material via saliva-kit will be collected.


Other Outcome Measures:
  • Perceived stress Scale (PSS) [ Time Frame: Baseline, 3 months after training and 3 months follow-up ] [ Designated as safety issue: No ]
    Parent report.

  • Barn Under Stress (BUS) [ Time Frame: Baseline, 3 months after training and 3 months follow-up ] [ Designated as safety issue: No ]
    Self report.


Estimated Enrollment: 288
Study Start Date: August 2012
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Social skills group training KONTAKT
N= 144 participants are offered group training KONTAKT. The intervention includes 12 (brief intervention) and 24 (long intervention) sessions.
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.
Other Names:
  • Social skills training
  • Social skills group training
  • KONTAKT
No Intervention: Control group (TAU), the usual intervention / treatment
N = 144 participants are received treatment as usual (pharmacological therapy, family therapy, Cognitive behavioral therapy etc).

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

Ages Eligible for Study:   8 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01854346

Contacts
Contact: Sven Bölte, Professor 0046703170105 sven.bolte@ki.se
Contact: Nora Choque Olsson, PhD student 004670 164 3890 nora.choque-olsson@ki.se

Locations
Sweden
Child & Adolescent Psychiatry Research Center, KIND Recruiting
Stockholm, Sweden, 11330
Contact: Nora Choque Olsson, PhD student    0046701643890    nora.choque-olsson@ki.se   
Principal Investigator: Sven Bölte, PhD, Professor         
Sub-Investigator: Nora Choque Olsson, PhD student         
Sponsors and Collaborators
Karolinska Institutet
Child and Adolescent Psychiatry (BUP), Stockholm
Stockholm County Council, Sweden
Stiftelsen Sunnerdahls Handikappfond
Swedish Science Council
Barnforskningen: ALB
Majblomman
Investigators
Principal Investigator: Sven Bölte, PhD, Professor Karolinska Institutet, Center of Neurodevelopmental Disorders (KIND)
  More Information

Additional Information:
Publications:
Responsible Party: Sven Bölte, Professor, PhD, head of pediatric neuropsychiatry unit, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01854346     History of Changes
Other Study ID Numbers: KONTAKT
Study First Received: April 20, 2013
Last Updated: May 6, 2015
Health Authority: Sweden: Regional Ethical Review Board
Sweden: Swedish Data Inspection Board

Keywords provided by Karolinska Institutet:
Autism spectrum disorder
Social skills training
Group training
Comorbidity
Intervention
Evidence-based

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Autistic Disorder
Child Development Disorders, Pervasive
Disease
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders
Mental Disorders Diagnosed in Childhood
Pathologic Processes

ClinicalTrials.gov processed this record on May 21, 2015