NCT01854346

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
296

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2013

Completed
25 days until next milestone

First Posted

Study publicly available on registry

May 15, 2013

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

August 22, 2017

Status Verified

August 1, 2017

Enrollment Period

3.6 years

First QC Date

April 20, 2013

Last Update Submit

August 18, 2017

Conditions

Keywords

Autism spectrum disorderSocial skills trainingGroup trainingComorbidityInterventionEvidence-based

Outcome Measures

Primary Outcomes (1)

  • Social Responsiveness Scale (SRS)

    Parent and teachers report.

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

Secondary Outcomes (4)

  • Adaptive Behavior Assessment System II (ABAS II)

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

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

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

  • Clinical Global Impression-Improvement/Severity (CGI)

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

  • Samples With DNA

    2 weeks after the beginning of the treatment

Other Outcomes (2)

  • Perceived stress Scale (PSS)

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

  • Barn Under Stress (BUS)

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

Study Arms (2)

Social skills group training KONTAKT

EXPERIMENTAL

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

Control group (TAU), the usual intervention / treatment

NO INTERVENTION

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

Interventions

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.

Also known as: Social skills training, Social skills group training, KONTAKT
Social skills group training KONTAKT

Eligibility Criteria

Age8 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Child & Adolescent Psychiatry Research Center, KIND

Stockholm, 11330, Sweden

Location

Related Publications (6)

  • Reichow B, Steiner AM, Volkmar F. Social skills groups for people aged 6 to 21 with autism spectrum disorders (ASD). Cochrane Database Syst Rev. 2012 Jul 11;2012(7):CD008511. doi: 10.1002/14651858.CD008511.pub2.

    PMID: 22786515BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 19165532BACKGROUND
  • 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.

    PMID: 24379174BACKGROUND
  • 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.

    PMID: 28647010BACKGROUND
  • 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.

Related Links

MeSH Terms

Conditions

Autism Spectrum DisorderAttention Deficit Disorder with HyperactivityAnxiety DisordersDepression

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersAttention Deficit and Disruptive Behavior DisordersBehavioral SymptomsBehavior

Study Officials

  • Sven Bölte, PhD, Professor

    Karolinska Institutet, Center of Neurodevelopmental Disorders (KIND)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, PhD, head of pediatric neuropsychiatry unit

Study Record Dates

First Submitted

April 20, 2013

First Posted

May 15, 2013

Study Start

August 1, 2012

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

August 22, 2017

Record last verified: 2017-08

Locations