Infants with communication and social concerns
Conditions
Interventions
Early start Denver model twice/month, 1 hour for each session, for 6 months
control
Treatment provided bythe local community, for 6 months
Sponsors
Osaka University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria:
Exclusion criteria
Exclusion criteria: 1. Children for whom information about developmental history cannot be provided by a parent. 2. Children with neurodevelopmental disorders with known causes, such as chromosomal abnormalities and malformation syndromes. 3. Children with severe sensory or motor impairments or serious physical illness 4. Children with epilepsy. 5. Children with a history of serious head injury. 6. Children with neuromusclar disorders. 7. Children with prenatal exposure for alcohol or drug. 8. Birth weight less than 2500 grams or gestational age less than 36 weeks. 9. Children who had received specialized treatment for autism prior to obtaining consent. 10. Children for whom the tests specified in this study cannot be performed within the specified period of time after consent is obtained. 11. Children with less than 35 Cognitive and motor scores or developmental age of less than 9 months by Bayley 3. 12. Children whom the Principal Investigator deems inappropriate as research subjects for other reasons. 13. Children suspected abuse by caregivers or whose parents suspect with mental illness or have difficulties in participating in research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change of the subscle A:communication of Autism Diagnostic Observation scheduled before and after intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| The change of the subscles B and C of Autism Diagnostic Observation scheduled, Bayley3, Vineland-II, social responsiveness score-2, Child behavior check list, and parent stress index-children. | — |
Countries
Japan
Contacts
Public ContactIKUKO MOHRI
Osaka University Medical Hospital Pediatrics
Outcome results
None listed