DSM-5 299.0 Autism Spectrum Disorder F84.0 F84.1 F84.5
Conditions
Interventions
Group 1: Children and adolescents with ASD receiving real electric stimulation (tDCS, 2mA current for 20 minutes) concurrent with computer based cognitive training over two weeks of five consecutive d
Sponsors
Goethe University Frankfurt
Eligibility
Sex/Gender
All
Age
10 Years to 17 Years
Inclusion criteria
Inclusion criteria: •Expert clinical ASD diagnosis according to DSM-5 supported by ADI-R and ADOS, including all Autism Spectrum Disorders (299.00) •Age = 10 to <18 years old at randomization •participant and their parents are able and willing to give written informed assent/consent
Exclusion criteria
Exclusion criteria: •IQ=70 o Developmental coordination disorder o Major Depressive Disorder: Mild Depressive Episode o Dysthymia o All Anxiety Disorders o All Elimination Disorders o Gender Dysphoria o Oppositional Defiant Disorder o ASD-related sleeping problems o ASD-related eating problems •Dermatological disease of the scalp or chronic skin damage •Any electrically, mechanically or magnetically activated implant (for example, brain implant, pacemakers, cardiac implants, vascular clips) •Heart disease •Current pregnancy or hormonal contraception •History of smoking within last five years •Concurrent psychopharmacological treatment that has an influence on the central nervous system •Concurrent neurofeedback or stimulation therapy •Participation in other clinical trials
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Change in the parent-rated Social Responsiveness Scale questionnaire (SRS-16 item short version,) between pre- and post-intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| -Change in parent rated social responsiveness questionnaire (SRS-16 item short version) between pre-intervention and at four weeks follow-up -Change in repetitive behavior (RBS-r), communication (CCC-2), additional psychopathology (CBCL, ABC), health-related quality of life (KIDSCREEN27, child and parent) and social cognition based on questionnaires, imitation ability based on behavioral observation (Imitation of non-meaningful gestures) between pre- and post-intervention and follow-up of four weeks -Change in neuropsychological (CANTAB), neurophysiological tasks and resting-state fMRI tasks between pre- and post-intervention and follow-up of four weeks | — |
Countries
France, Germany, Portugal
Contacts
Public ContactChristina Luckhardt
Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy & Autism Research and Intervention Center of Excellence, University Hospital Frankfurt, Goethe University
Outcome results
None listed