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Completed

NCT Number: NCT01854346

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

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.

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Key information

Conditions

Autism Spectrum Disorder (ASD) Anxiety Anxiety Disorders Attention Deficit Disorder with Hyperactivity Attention Deficit Hyperactivity Disorder (ADHD) Attention Deficit and Disruptive Behavior Disorders Autism Spectrum Disorder Behavior Behavioral Symptoms Child Development Disorders, Pervasive Depression Mental Disorders Neurodevelopmental Disorders

Age range

8 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Child & Adolescent Psychiatry Research Center, KIND

Stockholm, 11330, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Social skills group training, KONTAKT

Behavioral

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

Primary outcomes

  1. Social Responsiveness Scale (SRS)

    Time frame: Baseline, 3 months after training and 3 months follow-up

    Parent and teachers report.

Secondary outcomes

  1. Adaptive Behavior Assessment System II (ABAS II)

    Time frame: Baseline, 3 months after training and 3 months follow-up

    Parent and teachers report.

  2. 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.

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

    Time frame: Baseline, 3 months after training and 3 months follow-up

    Experts report.

  4. Samples With DNA

    Time frame: 2 weeks after the beginning of the treatment

    Genetic material via saliva-kit will be collected.

Other outcomes

  1. Perceived stress Scale (PSS)

    Time frame: Baseline, 3 months after training and 3 months follow-up

    Parent report.

  2. Barn Under Stress (BUS)

    Time frame: Baseline, 3 months after training and 3 months follow-up

    Self report.

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

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

Registry information

Official study 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.

Acronym: KONTAKT-RCT

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
May 15, 2013
Registry last updated
Aug 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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