UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052079 |
|---|---|
| Receipt number | R000059149 |
| Scientific Title | Effectiveness of Early start Denver model for infants' social and communication skills in Japan |
| Date of disclosure of the study information | 2023/09/01 |
| Last modified on | 2024/03/11 11:42:03 |
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Basic information
Public title
Effectiveness of Early start Denver model for infants' social and communication skills in Japan
Acronym
Effectiveness of ESDM
Scientific Title
Effectiveness of Early start Denver model for infants' social and communication skills in Japan
Scientific Title:Acronym
Effectiveness of Early start Denver model
Region
| Japan |
Condition
Condition
Infants with communication and social concerns
Classification by specialty
| Pediatrics | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim is examining the effectiveness of the Denver Early Intervention Method (ESDM) on social relationships and communication in Japan
Basic objectives2
Others
Basic objectives -Others
To developing a practical protocol for ESDM in Japan.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The change of the subscle A:communication of Autism Diagnostic Observation scheduled before and after intervention.
Key secondary outcomes
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.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Interventions; Early start Denver model twice/month, 1 hour for each session, for 6 months
Interventions/Control_2
control; Treatment provided bythe local community, for 6 months
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 24 | months-old | <= |
Age-upper limit
| 36 | months-old | > |
Gender
Male and Female
Key inclusion criteria
Children concerned about communication and socialites (problems in pointing, joint attention, significant word appearance, language comprehension, and behavior) and judged to require medical treatment and education.
Key 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.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | IKUKO |
| Middle name | |
| Last name | MOHRI |
Organization
Osaka University Medical Hospital
Division name
Pediatrics
Zip code
5650871
Address
2-2, Yamadaoka, Suita-shi, Osaka uitashi,
TEL
06-6879-3863
ikuko@kokoro.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | IKUKO |
| Middle name | |
| Last name | MOHRI |
Organization
Osaka University Medical Hospital
Division name
Pediatrics
Zip code
5650871
Address
2-2, Yamadaoka, Suita-shi, Osaka
TEL
06-6879-3863
Homepage URL
https://www.med.osaka-u.ac.jp/pub/ped/www/study/index.html
ikuko@kokoro.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Ikuko Mohri
Funding Source
Organization
Osaka University, Hirosaki University, Kanazawa University
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Reviw Board, Osaka University Medical Hospital
Address
2-2, Yamadaoka, Suita-shi, Osaka
Tel
06-6210-8296
rinri@hp-crc.med.osaka-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
大阪大学医学部附属病院、弘前大学医学部附属病院、金沢大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2023 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 09 | Month | 11 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Licensing has been delayed, so, registration has not yet begun.
Management information
Registered date
| 2023 | Year | 09 | Month | 01 | Day |
Last modified on
| 2024 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059149
