Social Skills Group Training ("KONTAKT") for Children and Adolescent With High-functioning Autism Spectrum Disorders (KONTAKT-RCT)
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|ClinicalTrials.gov Identifier: NCT01854346|
Recruitment Status : Completed
First Posted : May 15, 2013
Last Update Posted : August 22, 2017
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|Condition or disease||Intervention/treatment||Phase|
|Autism Spectrum Disorder (ASD) Attention Deficit Hyperactivity Disorder (ADHD) Anxiety Depression||Behavioral: Social skills group training, KONTAKT||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||296 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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.|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||March 2016|
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.
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).
- Social Responsiveness Scale (SRS) [ Time Frame: Baseline, 3 months after training and 3 months follow-up ]Parent and teachers report.
- Adaptive Behavior Assessment System II (ABAS II) [ Time Frame: Baseline, 3 months after training and 3 months follow-up ]Parent and teachers report.
- 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.
- Clinical Global Impression-Improvement/Severity (CGI) [ Time Frame: Baseline, 3 months after training and 3 months follow-up ]Experts report.
- Samples With DNA [ Time Frame: 2 weeks after the beginning of the treatment ]Genetic material via saliva-kit will be collected.
- Perceived stress Scale (PSS) [ Time Frame: Baseline, 3 months after training and 3 months follow-up ]Parent report.
- Barn Under Stress (BUS) [ Time Frame: Baseline, 3 months after training and 3 months follow-up ]Self report.
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|Ages Eligible for Study:||8 Years to 17 Years (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01854346
|Child & Adolescent Psychiatry Research Center, KIND|
|Stockholm, Sweden, 11330|
|Principal Investigator:||Sven Bölte, PhD, Professor||Karolinska Institutet, Center of Neurodevelopmental Disorders (KIND)|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Sven Bölte, Professor, PhD, head of pediatric neuropsychiatry unit, Karolinska Institutet|
|Other Study ID Numbers:||
|First Posted:||May 15, 2013 Key Record Dates|
|Last Update Posted:||August 22, 2017|
|Last Verified:||August 2017|
Autism spectrum disorder
Social skills training
Attention Deficit Disorder with Hyperactivity
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Attention Deficit and Disruptive Behavior Disorders