UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054170 |
|---|---|
| Receipt number | R000061828 |
| Scientific Title | A Study of Changes in DQ Values of Children with ASD by Low-Intensity Behavioral Intervention Training at a Child Development Support Office |
| Date of disclosure of the study information | 2024/05/01 |
| Last modified on | 2025/10/18 16:25:10 |
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Basic information
Public title
A Study of Changes in DQ Values of Children with ASD by Low-Intensity Behavioral Intervention Training at a Child Development Support Office
Acronym
A Study of Changes in DQ Values of Children with ASD by Low-Intensity Behavioral Intervention Training at a Child Development Support Office
Scientific Title
A Study of Changes in DQ Values of Children with ASD by Low-Intensity Behavioral Intervention Training at a Child Development Support Office
Scientific Title:Acronym
A Study of Changes in DQ Values of Children with ASD by Low-Intensity Behavioral Intervention Training at a Child Development Support Office
Region
| Japan |
Condition
Condition
Autism Spectrum Disorder
Classification by specialty
| Pediatrics | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Low-Intensity Behavioral Intervention(LIBI)based on Applied Behavior Analysis (ABA), which mainly consists of face-to-face individual therapy at a desk within the framework of public services at a child development support center, was used to examine the effectiveness of LIBI in improving the DQ of children with ASD. The purpose of this study is to examine the effectiveness of LIBI(Low-Intensity Behavioral Intervention) in improving DQ of children with ASD.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
change in overall developmental quotient (DQ)
Key secondary outcomes
DQ change in each domain, effect of age at enrollment (in months) on overall DQ change, effect of number of therapy hours per week on overall DQ change, difference in overall DQ change with and without concurrent use of other facilities, difference in overall DQ change by severity (severe, moderate, mild) Differences in overall DQ change. Behavioral changes due to support and advice to parents are not included in the evaluation items.
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
| 1 | months-old | <= |
Age-upper limit
| 6 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. preschooler (6 years old or younger).
2. children diagnosed with ASD at a medical institution. 3. children who have been attending the center for at least 1 year.
The KIDS is a standardized questionnaire that captures the development of infants and toddlers in terms of their overall natural behavior and consists of nine items: motor, manipulative, language (comprehension, expression, and concepts), social (with adults and children), discipline, and eating. It is standardized.
Key exclusion criteria
1. exclude cases with the following diagnoses of organic or genetic diseases in medical institutions Rett syndrome, fragile X syndrome, and tuberous sclerosis.
2. Subjects will be excluded if family members or other proxies of the subject wish not to participate in the study.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Fumihiro |
| Middle name | |
| Last name | Hayashi |
Organization
Child Development Support/Visit Support for Nursery Office
"MAMAMA TO MAMAMA"
Division name
manager
Zip code
864-0161
Address
8-86,Sakuragaoka,Kasuga,Fukuoka,816-0872,Japan
TEL
0925866696
mamama.sakura@gmail.com
Public contact
Name of contact person
| 1st name | Fumihiro |
| Middle name | |
| Last name | Hayashi |
Organization
Office SlowLife, Inc.
Division name
President
Zip code
816-0872
Address
8-86,Sakuragaoka,Kasuga,Fukuoka,816-0872,Japan
TEL
0925866529
Homepage URL
slowlife.office@gmail.com
Sponsor or person
Institute
Office SlowLife, Inc.
Institute
Department
Personal name
Funding Source
Organization
Non
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Office SlowLife, Inc.
Address
8-86,Sakuragaoka,Kasuga,Fukuoka,816-0872,Japan
Tel
0925866529
slowlife.office@gmail.com
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
| 2024 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
http://mamamatomamama.net/news/%e8%87%a8%e5%ba%8a%e7%a0%94%e7%a9%b6%e3%81%ae%e3%81%8a%e7%9f%a5%e3%82
Publication of results
Partially published
Result
URL related to results and publications
https://jglobal.jst.go.jp/detail?JGLOBAL_ID=202402282987687658
Number of participants that the trial has enrolled
40
Results
A comparison between the initial and the most recent assessments showed a significant improvement.The developmental quotient increased by 8.6 points, indicating a moderate effect.
Results date posted
| 2025 | Year | 10 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Among 100 children who attended the facility up to October 2023,40 had been diagnosed with ASD and had taken the KIDS (Infant Developmental Scale, Type T) test at least twice, with an interval of one year or more between assessments.
Participant flow
Over a period of approximately nine years,100 children were sequentially accepted into the program after their parents visited for consultation and observation and expressed a desire to enroll.Among them, 40cases(36boys and 4girls) were selected for analysis - those who had received intervention for more than one year, had a medical diagnosis of ASD without organic or genetic disorders, and had taken the KIDS(Infant Developmental Scale) test at least twice with an interval of one year or more.
Adverse events
No significant events observed.
Outcome measures
Developmental Quotient (DQ)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2024 | Year | 03 | Month | 08 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 18 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 18 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The outline of this observational study is as follows
1. conduct an initial KIDS at the beginning with ABA therapy at the office and record the DQ.
2. ABA therapy will be conducted (1 hour/time, 1.5-5 times/week).
3. Conduct KIDS every year and record DQ.
4. conduct a t-test with correspondence between the first DQ and the most recent DQ to examine the effect of ABA therapy; expected duration of participation of ABA therapy subjects: from admission to graduation/exit (1 year to 6 years).
Of the 100 cases who participated in this ABA therapy, we will conduct a statistical analysis of 40 cases who had a diagnosis of ASD, had behavioral intervention for at least one year, and had the Infant Developmental Screening Scale (hereinafter referred to as KIDS) administered at least twice. Based on the results of the DQ analysis of the children with ASD who received low-Intensity behavioral intervention for less than 5 hours per week at our center, this study will examine the effectiveness of professional support and therapy with ABA as an overall support method for the development of children with ASD and their families. . This study is a before-and-after comparative study (backward-looking observational study) of the practice of treatment and education with ABA therapy in a project that focuses on individualized functional training, starting from the past.
Management information
Registered date
| 2024 | Year | 04 | Month | 16 | Day |
Last modified on
| 2025 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061828
