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.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Autism Spectrum Disorder (ASD)
- Sponsor
- Karolinska Institutet
- Enrollment
- 296
- Locations
- 1
- Primary Endpoint
- Social Responsiveness Scale (SRS)
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Sven Bölte
Professor, PhD, head of pediatric neuropsychiatry unit
Karolinska Institutet
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Social Responsiveness Scale (SRS)
Time Frame: Baseline, 3 months after training and 3 months follow-up
Parent and teachers report.
Secondary Outcomes
- 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)