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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Karolinska Institutet
- Enrollment
- 296
- Locations
- 2
- Primary Endpoint
- Social Responsiveness Scale (SRS)
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 8 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Social skills group training KONTAKT
N= 144 participants are offered group training KONTAKT. The intervention includes 12 (brief intervention) and 24 (long intervention) sessions.
Intervention: Social skills group training, KONTAKT (Behavioral)
Control group (TAU), the usual intervention / treatment
N = 144 participants are received treatment as usual (pharmacological therapy, family therapy, Cognitive behavioral therapy etc).
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)
Investigators
Sven Bölte
Professor, PhD, head of pediatric neuropsychiatry unit
Karolinska Institutet