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Autism Spectrum Disorder (ASD)KONTAKT-RCTNCT01854346

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

A study testing Social skills group training, KONTAKT in people with Autism Spectrum Disorder (ASD) and Attention Deficit Hyperactivity Disorder (ADHD), run by Karolinska Institutet at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 8 to 17 years
What is being tested?
Social skills group training, KONTAKT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
296 participants
Where
1 siteSweden
Study dates
Aug 2012to Mar 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Child & Adolescent Psychiatry Research Center, KIND

    Stockholm, 11330

Other trials in Sweden

About this study

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.

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.

Read the 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.

Being tested
Social skills group training, KONTAKT
Keywords
Autism spectrum disorder, Social skills training, Group training, Comorbidity, Intervention, Evidence-based
Medical subject headings
Autism Spectrum Disorder, Attention Deficit Disorder with Hyperactivity, Anxiety Disorders, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Social skills group training, KONTAKTBehavioural

    Also called Social skills training, 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.

Study groups in NCT01854346
Study groupRoleWhat they receive
Social skills group training KONTAKTExperimentalN= 144 participants are offered group training KONTAKT. The intervention includes 12 (brief intervention) and 24 (long intervention) sessions.
Receives: Behavioral: Social skills group training, KONTAKT
Control group (TAU), the usual intervention / treatmentNo interventionN = 144 participants are received treatment as usual (pharmacological therapy, family therapy, Cognitive behavioral therapy etc).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Social Responsiveness Scale (SRS)

    Parent and teachers report.

    Measured: Baseline, 3 months after training and 3 months follow-up

Secondary outcomes (4)

  1. Adaptive Behavior Assessment System II (ABAS II)

    Parent and teachers report.

    Measured: Baseline, 3 months after training and 3 months follow-up

  2. Developmental Disabilities Modification of the Children's Global Assessment Scale (DD-CGAS)

    Experts report.

    Measured: Baseline, 3 months after training and 3 months follow-up

  3. Clinical Global Impression-Improvement/Severity (CGI)

    Experts report.

    Measured: Baseline, 3 months after training and 3 months follow-up

  4. Samples With DNA

    Genetic material via saliva-kit will be collected.

    Measured: 2 weeks after the beginning of the treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2013 (estimated)
  2. Study startAug 2012
  3. Primary completionMar 2016
  4. Study completionMar 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
296 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01854346
Sponsor's protocol ID
KONTAKT
Acronym
KONTAKT-RCT
Status last verified
Aug 2017
First submitted
20 Apr 2013
Last updated
22 Aug 2017
Results posted
No
Data monitoring committee
No

Publications

  • 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.

  • 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.

  • 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.

    PubMed 19165532

  • 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.

    PubMed 24379174

  • 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.

    PubMed 28647010

  • 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.

    PubMed 26912485

Questions about this trial

What is this clinical trial studying?

A study testing Social skills group training, KONTAKT in people with Autism Spectrum Disorder (ASD) and Attention Deficit Hyperactivity Disorder (ADHD), run by Karolinska Institutet at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Social Responsiveness Scale (SRS) (time frame: Baseline, 3 months after training and 3 months follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01854346, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2017.

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