Effectiveness of Early start Denver model for infants' social and communication skills in Japa
- Conditions
- Infants with communication and social concerns
- Registration Number
- JPRN-UMIN000052079
- Lead Sponsor
- Osaka University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 70
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The change of the subscle A:communication of Autism Diagnostic Observation scheduled before and after intervention.
- Secondary Outcome Measures
Name Time Method 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.