Anxiety, Attention Deficit Hyperactivity Disorder (ADHD), Autism Spectrum Disorder (ASD), Depression
Conditions
Keywords
Autism spectrum disorder, Social skills training, Group training, Comorbidity, Intervention, Evidence-based
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.
Interventions
BEHAVIORALSocial 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.
Sponsors
Child and Adolescent Psychiatry, Stockholm
Region Stockholm
Stiftelsen Sunnerdahls Handikappfond
The Swedish Research Council
The Pediatric Research Foundation at Astrid Lindgren Children's Hospital
Majblomman
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
8 Years to 17 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Social Responsiveness Scale (SRS) | Baseline, 3 months after training and 3 months follow-up | Parent and teachers report. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Perceived stress Scale (PSS) | Baseline, 3 months after training and 3 months follow-up | Parent report. |
| Barn Under Stress (BUS) | Baseline, 3 months after training and 3 months follow-up | Self report. |
Countries
Sweden
Outcome results
None listed