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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
296

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

4 years to 13 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Karolinska Institutet

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 20, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 15, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 22, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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