Health Condition 1: F84- Pervasive developmental disorders
Conditions
Interventions
Intervention1: Melatonin therapy: Children with ASD with Composite Sleep Disturbance score 4 and above will get 1.5 mg melatonin per day for 2 weeks.
Control Intervention1: Sleep hygiene pamphlet: Chi
Sponsors
Central Institute of Psychiatry
Eligibility
Inclusion criteria
Inclusion criteria: 1 Children diagnosed with Autism Spectrum Disorder as per ICD-11 between age 5-10 years. 2 Children with ASD who are drug-naive or drug-free for two weeks. 3 Children of either gender between age 5-10 years of age. 4 Score of 4 and above on Composite Sleep Disturbance Score (CSDI)
Exclusion criteria
Exclusion criteria: Children with known genetic or neurological syndrome with an established link to autism, history of epilepsy or current seizures, motor or sensory impairment that would interfere with the valid completion of study measures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the effectiveness of Syrup Melatonin (1.5 mg/day) on the total sleep time & sleep onset latency in children with ASD in comparison to children with ASD receiving sleep hygiene pamphlet.Timepoint: Baseline , 2 Weeks , 4 Weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 To assess the effectiveness of Syrup Melatonin (1.5 mg/day) on the behaviour & quality of life in children with ASD in comparison to children with ASD receiving sleep hygiene pamphlet. 2 To assess and compare the urinary 6-Sultatoxy Melatonin (6-SM) levels in children with ASD and age-sex matched typically developing children. 3 To see the relationship of urinary 6-Sultatoxy Melatonin (6-SM) with the clinical characteristics, and sleep parameters among children with ASD receiving Syrup Melatonin (1.5 mg/day).Timepoint: Baseline , 2 Weeks , 4 Weeks | — |
Countries
India
Contacts
Public ContactDr Varun S Mehta
Central Institute of Psychiatry
Outcome results
None listed