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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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Autism Spectrum Disorder (ASD), Attention Deficit Hyperactivity Disorder (ADHD), Anxiety, Depression

Intervention / Treatment
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* Behavioral: Social skills group training, KONTAKT


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Social skills group training KONTAKT<br>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<br>* 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.<br>* Other names: KONTAKT;|
| No Intervention: Control group (TAU), the usual intervention / treatment<br>N = 144 participants are received treatment as usual (pharmacological therapy, family therapy, Cognitive behavioral therapy etc). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Social Responsiveness Scale (SRS) | 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) | 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) | Experts report. | Baseline, 3 months after training and 3 months follow-up | 
| Clinical Global Impression-Improvement/Severity (CGI) | Experts report. | Baseline, 3 months after training and 3 months follow-up | 
| Samples With DNA | Genetic material via saliva-kit will be collected. | 2 weeks after the beginning of the treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Autism spectrum disorder, Social skills training, Group training, Comorbidity, Intervention, Evidence-based