UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057412 |
|---|---|
| Receipt number | R000064208 |
| Scientific Title | Clarifying the relationship between early ABA treatment for children with autism spectrum disorder and prognosis 2 to 3 years later: Multi-center joint prospective observation laboratory |
| Date of disclosure of the study information | 2025/03/31 |
| Last modified on | 2025/05/01 21:22:44 |
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Basic information
Public title
A prospective observational study to examine the outcomes of autistic children 2 to 3 years after receiving ABA early treatment
Acronym
After 2 to 3 years of autistic children receiving ABA early treatment
Scientific Title
Clarifying the relationship between early ABA treatment for children with autism spectrum disorder and prognosis 2 to 3 years later:
Multi-center joint prospective observation laboratory
Scientific Title:Acronym
Prospective observational study of the prognosis of autistic children 2 to 3 years after early ABA therapy
Region
| Japan |
Condition
Condition
Autism Spectrum Disorder
Classification by specialty
| Pediatrics | Psychiatry | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine the Developmental Quotient (DQ) or Intelligence Quotient (IQ) after 2 years for preschool children diagnosed with Autism Spectrum Disorder (ASD).
A comparison is made between the case of early ABA therapy and the case of other therapy (or no therapy).
Same studies are conducted regarding DQ and IQ after 1 year and 3 years.
Basic objectives2
Others
Basic objectives -Others
Examine the Following after 1 -3 yeras for preschool children diagnosed with ASD:
1) whether obsessions and stereotypic behaviors decrease
2) whether emotional problems, inappropriate behavior, or difficulties decrease
3) whether prosocial behavior increase
4) whether sensory sensitivity decrease
5) whether the students attend different schools (regular class, special needs class, special needs school)
6) whether rates of psychotropic medication use differ
7) whether the child feel happy in life
Regarding all of the above 1) to 7),
comparisons are made between the case of early ABA therapy and the case of other therapy (or no therapy).
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
DQ/IQ at diagnosis and 2 years after diagnosis
Key secondary outcomes
Changes in intellectual ability after early ABA treatment for ASD
DQ/IQ at diagnosis, 1 year after diagnosis, and 3 years after diagnosis
Regarding other items
1. Localized interests and repetitive behaviors (SRS-2)
2. Social Communication (SRS-2)
3. Emotional problems (SDQ)
4. Conduct Problems (SDQ)
5. Overall Difficulty (SDQ)
6. Prosocial Behavior (SDQ)
7. Degree of sensory sensitivity (SP sensory profile)
8. Parental Mental Health Survey (GHQ12)
9. Annual household income, whether parents are divorced or not
10. Whether or not to take medication
11. Questions about happiness
12. School attended/addressed
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 30 | months-old | <= |
Age-upper limit
| 83 | months-old | > |
Gender
Male and Female
Key inclusion criteria
Patients must meet all of the following criteria.
(1) Patients newly diagnosed with autism spectrum disorder (ASD)
Autism spectrum disorder (ASD) diagnostic criteria shall follow the DSM-5 (2013) criteria.
(2) Patients aged 2 years and 6 months or older at the time of obtaining consent and who are not yet attending school
(3) Patients whose guardians have an ePRO (electronic patient-reported outcomes) input environment, and the guardians can enter data
(4) Patients who have obtained written consent from their legal representative for this study
Key exclusion criteria
Patients who fall under any of the following will not be included in this study.
(1) If the research director or co-researcher determines that participation in this research is inappropriate
(2) Patients who have received early ABA treatment by the time consent was obtained
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | HIDEHIKO |
| Middle name | |
| Last name | FUJINAKA |
Organization
NHO Niigata National Hospital
Division name
Department of Clinical Research
Zip code
945-8585
Address
3-52 Akasaka-cho, Kashiwazaki city, Niigata prefecture
TEL
0257-22-2126
fujinaka.hidehiko.yf@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | Chiharu |
| Middle name | |
| Last name | Kawakami |
Organization
NHO Niigata National Hospital
Division name
Medical Department, Document Room
Zip code
945-8585
Address
3-52 Akasaka-cho, Kashiwazaki city, Niigata prefecture
TEL
0257-22-2126
Homepage URL
225-syo2kenkyu@hospnet.onmicrosoft.com
Sponsor or person
Institute
NHO Niigata national Hospital
Institute
Department
Personal name
Hidehiko Fujinaka
Funding Source
Organization
NHO Niigata national Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Central review board of National Hospital Organization
Address
2-5-21 Higashigaoka, Meguro-ku, Tokyo, 152-8621, Japan
Tel
03-5712-5075
700-kenkyu@mail.hosp.go.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 03 | Month | 31 | 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
| 2025 | Year | 02 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Main endpoint
DQ/IQ at diagnosis and 2 years after diagnosis
Secondary endpoints
1. DQ/IQ at diagnosis, 1 year after diagnosis, and 3 years after diagnosis
2. SRS-2 at diagnosis and 1, 2, and 3 years after diagnosis
3. SDQ at diagnosis and 1, 2, and 3 years after diagnosis
4. SP sensory profile at diagnosis and 1, 2, and 3 years after diagnosis
5. GHQ12 at diagnosis and 1, 2, and 3 years after diagnosis
6. Annual household income and whether parents are divorced at the time of diagnosis
7. Administration status
8. Questions about well-being at diagnosis and 1, 2, and 3 years after diagnosis
9. Enrollment school/admission destination
Management information
Registered date
| 2025 | Year | 03 | Month | 26 | Day |
Last modified on
| 2025 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064208
