Health Condition 1: F840- Autistic disorder
Conditions
Interventions
Intervention1: Risperidone: Total dose 0.25-0.5 mg/day in 2 divided doses given orally for 8 weeks.
Intervention will be provided in addition to Standard of Care
Control Intervention1: Standard of car
Sponsors
Dr Ritika Chaudhry
Dr Leena Srivastava
Eligibility
Inclusion criteria
Inclusion criteria: 1) Age between 2 to 5 years. 2) Autism Spectrum Disorder diagnosed by DSM-5 criteria/INCLEN-ASD tool in the past 6 months. 3) Behavioral problems defined as presence of one or more of the following 5 behaviors reported as moderate or serious problems on the Autism Treatment Evaluation Checklist (ATEC) tool: hyperactive, destructive, self-injurious behaviors, often agitated, repetitive movements. 4) Parents give informed consent for the study
Exclusion criteria
Exclusion criteria: 1) Children having secondary ASD. 2) Children administered any psychotropic drugs in the past 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in scores on the Autism Treatment Evaluation Checklist (ATEC) ToolTimepoint: 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in individual behavior rating items on Autism Treatment Evaluation Checklist (ATEC) ToolTimepoint: 8 weeks;clinical monitoring of adverse effects or compliance issuesTimepoint: 8 weeks | — |
Countries
India
Contacts
Public ContactDr Ritika Chaudhry
Bharati Vidyapeeth Medical College and Hospital, Pune
Outcome results
None listed