UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054162 |
|---|---|
| Receipt number | R000060776 |
| Scientific Title | Examining Service Factors Affecting Participation of Children with Autism Spectrum Disorders by Propensity Scores |
| Date of disclosure of the study information | 2024/04/17 |
| Last modified on | 2024/04/16 11:53:38 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Services children with autism spectrum disorder receive: what improves participation?
Acronym
Services children with autism spectrum disorder receive: what improves participation?
Scientific Title
Examining Service Factors Affecting Participation of Children with Autism Spectrum Disorders by Propensity Scores
Scientific Title:Acronym
Examining Service Factors Affecting Participation of Children with Autism Spectrum Disorders by Propensity Scores
Region
| Japan |
Condition
Condition
Preschoolers with autism spectrum disorder
Classification by specialty
| Not applicable | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The main objective of this study is to determine whether various types of support services received by young children with autism spectrum disorder improve participation. In particular, this study will use propensity scores to analyze the impact of the involvement of psychologists, occupational therapists, and physical therapists on children's participation and mental health. Through this study, we aim to provide knowledge to develop a more effective support system for children with autism.
Basic objectives2
Others
Basic objectives -Others
The second objective of this study is to examine what classes Children's Participation and Mental Health fall into and how they vary through latent transfer analysis of theParticipation Questionnaire for Preschoolers (PQP) and the Strength and Difficulties Questionnaire (SDQ), respectively, and to identify factors that influence them. A third objective is to examine the longitudinal measurement properties of the PQP.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Participation Questionnaire for Preschoolers
Key secondary outcomes
Strength and Difficulties Questionnaire
Family Outcomes Surveys
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
| 51 | months-old | <= |
Age-upper limit
| 75 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) have not received a diagnosis of any neurodevelopmental disorders other than those being studied
(2) have an Intelligence Quotient (IQ) of 50 or higher as measured by the Wechsler Intelligence Scale for Children, the Wechsler Preschool and Primary Scale of Intelligence, or the Tanaka-Binet Intelligence Scale, or have a Developmental Quotient (DQ) of 50 or higher on the Kyoto Scale of Psychological Development.
Key exclusion criteria
none.
Target sample size
350
Research contact person
Name of lead principal investigator
| 1st name | Takuto |
| Middle name | |
| Last name | Nakamura |
Organization
Kanagawa University of Human Services
Division name
School of Rehabilitation
Zip code
2388522
Address
Heiseicho1-10-1 Yokosuka city, Kanagawa prefecture
TEL
0468822804
nakamura-y49@kuhs.ac.jp
Public contact
Name of contact person
| 1st name | Takuto |
| Middle name | |
| Last name | Nakamura |
Organization
Kanagawa University of Human Services
Division name
School of Rehabilitation
Zip code
2388522
Address
Heiseicho1-10-1 Yokosuka city, Kanagawa prefecture
TEL
0468822804
Homepage URL
nakamura-y49@kuhs.ac.jp
Sponsor or person
Institute
Kanagawa University oh Human Services
Institute
Department
Personal name
Takuto Nakamura
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board at Kanagawa University of Human Services
Address
Heiseicho1-10-1 Yokosuka city, Kanagawa prefecture
Tel
0468822804
jimu-rinri@kuhs.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 04 | Month | 17 | 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
603
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 06 | Month | 15 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 15 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 30 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We are requesting responses to questionnaires from 350 caregivers of children with autism spectrum disorder aged 48-71 months at four different points in time. Initially, participants are asked to complete the Participation Questionnaire for Preschoolers (PQP), Demographic Questionnaire, Strengths and Difficulties Questionnaire (SDQ), Family Outcome Survey (FOS-J), and Global Rating of Change Scales (GRC). The second data collection occurs one week after the first, including PQP, GRC, and Social Responsiveness Scale Second Edition (SRS-2). The third data collection, conducted three months after the second, requests responses to PQP, SDQ, GRC, FOS-J, and Demographic Questionnaire. The fourth collection, three months following the third, involves PQP, SDQ, FOS-J, and Global Rating Scales.Test-retest reliability is verified by calculating the intraclass correlation coefficients for PQP between the first and second surveys for participants who reported "no change" in GRC. Reactivity is evaluated by correlating changes in PQP scores with changes in the SDQ subdomains of Total Difficulties and Prosocial Behavior, as well as the total scores of FOS-J. Additionally, minimal important change (MIC) is determined using ROC curves for PQP and GRC.Furthermore, separate latent transition analyses are conducted based on the scores of each factor of PQP and SDQ to verify the transition probabilities among classes from the first to the fourth survey. Lastly, propensity score matching using PQP, Demographic Questionnaire, SRS-2, SDQ, and FOS-J is employed to compare changes in scores related to motor coordination between groups that utilized services of occupational therapists, physical therapists, and psychologists versus those who did not. If the variables used for propensity scores are insufficient, a difference-in-differences analysis will be employed to compare trends in score changes between the groups. Statistical analyses will utilize SPSS Statistics 25.0 and Latent Gold 4.0.
Management information
Registered date
| 2024 | Year | 04 | Month | 16 | Day |
Last modified on
| 2024 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060776
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
