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

August 18, 2017 updated by: Sven Bölte, Karolinska Institutet

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

296

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 11330
        • Child & Adolescent Psychiatry Research Center, KIND

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Social Responsiveness Scale (SRS)
Time Frame: Baseline, 3 months after training and 3 months follow-up
Parent and teachers report.
Baseline, 3 months after training and 3 months follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adaptive Behavior Assessment System II (ABAS II)
Time Frame: Baseline, 3 months after training and 3 months follow-up
Parent and teachers report.
Baseline, 3 months after training and 3 months follow-up
Developmental Disabilities Modification of the Children's Global Assessment Scale (DD-CGAS)
Time Frame: Baseline, 3 months after training and 3 months follow-up
Experts report.
Baseline, 3 months after training and 3 months follow-up
Clinical Global Impression-Improvement/Severity (CGI)
Time Frame: Baseline, 3 months after training and 3 months follow-up
Experts report.
Baseline, 3 months after training and 3 months follow-up
Samples With DNA
Time Frame: 2 weeks after the beginning of the treatment
Genetic material via saliva-kit will be collected.
2 weeks after the beginning of the treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perceived stress Scale (PSS)
Time Frame: Baseline, 3 months after training and 3 months follow-up
Parent report.
Baseline, 3 months after training and 3 months follow-up
Barn Under Stress (BUS)
Time Frame: Baseline, 3 months after training and 3 months follow-up
Self report.
Baseline, 3 months after training and 3 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Collaborators

The Swedish Research Council
Region Stockholm
Stiftelsen Sunnerdahls Handikappfond
Child and Adolescent Psychiatry, Stockholm
The Pediatric Research Foundation at Astrid Lindgren Children's Hospital
Majblomman

Investigators

  • Principal Investigator: Sven Bölte, PhD, Professor, Karolinska Institutet, Center of Neurodevelopmental Disorders (KIND)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

April 20, 2013

First Submitted That Met QC Criteria

May 11, 2013

First Posted (Estimate)

May 15, 2013

Study Record Updates

Last Update Posted (Actual)

August 22, 2017

Last Update Submitted That Met QC Criteria

August 18, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KONTAKT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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