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

Not Applicable

Completed

• Conditions: Anxiety; Depression; Attention Deficit Hyperactivity Disorder (ADHD); Autism Spectrum Disorder (ASD)
• Interventions: Behavioral: Social skills group training, KONTAKT

• Registration Number: NCT01854346
• Lead Sponsor: Karolinska Institutet

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.

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.

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2013-04-20
• Study First Submitted QC: 2013-05-11
• Study First Posted: 2013-05-15
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-18
• Last Update Posted: 2017-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 296

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Social skills group training KONTAKT	Social skills group training, KONTAKT	N= 144 participants are offered group training KONTAKT. The intervention includes 12 (brief intervention) and 24 (long intervention) sessions.

Primary Outcome Measures

Name	Time	Method
Social Responsiveness Scale (SRS)	Baseline, 3 months after training and 3 months follow-up	Parent and teachers report.

Secondary Outcome Measures

Name	Time	Method
Adaptive Behavior Assessment System II (ABAS II)	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)	Baseline, 3 months after training and 3 months follow-up	Experts report.
Clinical Global Impression-Improvement/Severity (CGI)	Baseline, 3 months after training and 3 months follow-up	Experts report.
Samples With DNA	2 weeks after the beginning of the treatment	Genetic material via saliva-kit will be collected.

Trial Locations

Locations (1)

Child & Adolescent Psychiatry Research Center, KIND; 🇸🇪 Stockholm, Sweden