Autism spectrum disorder Mental and Behavioural Disorders
Conditions
Interventions
Permuted randomized blocks (blocks of four, allocation ratio 1:1) will be used by an independent party, who was not involved elsewhere in the trial, to generate the randomization codes. Allocation con
Sponsors
Roozbeh Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Children aged 4–12 years 2. Male or female 3. Outpatients referred to clinic with probable autistic signs and symptoms and who meet the DSM-5 criteria
Exclusion criteria
Exclusion criteria: 1. Concurrent prominent psychiatric disorder 2. Preexisting medical conditions (in particular epileptic disorders and febrile seizures) 3. Intellectual disability (IQ <70) 4. History of drug or alcohol abuse 5. History of tardive dyskinesia 6. History of taking antipsychotic medication within 6 months prior to enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Irritability is measured using the Aberrant Behavior Checklist (ABC) at baseline, week 4, week 8, and week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Lethargy/social withdrawal is measured using the Aberrant Behavior Checklist (ABC) at baseline, week 4, week 8, and week 12 2. Stereotypic behavior is measured using the Aberrant Behavior Checklist (ABC) at baseline, week 4, week 8, and week 12 3. Inappropriate speech is measured using the Aberrant Behavior Checklist (ABC) at baseline, week 4, week 8, and week 12 4. Hyperactivity/noncompliance is measured using the Aberrant Behavior Checklist (ABC) at baseline, week 4, week 8, and week 12 | — |
Countries
Iran
Contacts
Public ContactMohamad Farhadi-shahi
Outcome results
None listed