An observational study to verify the reliability and validity of the Japanese version of the M-CHAT-R/F in Japanese infants

An observational study to verify the reliability and validity of the Japanese version of the M-CHAT-R/F in Japanese infants - Reliability and validity verification study of the Japanese version of M-CHAT-R/F

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000051738

Enrollment

Registered

2023-07-28

Start date

2023-07-28

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. the child must be between 16 and 30 months of age at the time consent is obtained 2. the primary caregiver and the child must be living together at the time consent is obtained 3. the parent or guardian of the subject child agrees with the content of the study and gives written consent for participation in the study 4. the parent/guardian of the subject child is able to understand the Japanese language described in the consent document and the questionnaire.

Exclusion criteria

Exclusion criteria: 1. the parent or guardian of the research subject child is under 18 years of age 2. parents or guardians of the research subject child who require a surrogate guardian; 3. the research subject child has already been diagnosed with ASD 3. the research subject child has already been diagnosed with ASD 4. the research subject child has a severe mental or physical disability 5. Other subjects who are deemed inappropriate to participate in this study by the Principal Investigator or a Research Supervisor.

Design outcomes

Primary

Measure	Time frame
Validity: Area under the curve (AUC of ROC) of ASD diagnoses assessed based on the M-CHAT-R/F Japanese version against the presence or absence of autism spectrum disorder/autism spectrum disorder (ASD) as assessed by the ADOS-2, ADI-R or PARS-TR - Agreement (Cohen's Kappa coefficient) between the presence or absence of ASD assessed by a team of experts skilled in ASD clinical practice based on the ADOS-2 and the ADI-R or PARS-TR in accordance with the DSM-5 and ASD diagnostic results assessed in accordance with the M-CHAT-R/F Japanese version. Agreement (Cohen's Kappa coefficient) between the Japanese version of the Infant and Toddler Developmental Screening Questionnaire (ASQ-3) and ASD diagnostic results assessed based on the Japanese version of the M-CHAT-R/F. Reliability:Reliability of the M-CHAT-R/F Japanese version (Cronbach's alpha coefficient)	—

Measure

Time frame

Validity: Area under the curve (AUC of ROC) of ASD diagnoses assessed based on the M-CHAT-R/F Japanese version against the presence or absence of autism spectrum disorder/autism spectrum disorder (ASD) as assessed by the ADOS-2, ADI-R or PARS-TR - Agreement (Cohen's Kappa coefficient) between the presence or absence of ASD assessed by a team of experts skilled in ASD clinical practice based on the ADOS-2 and the ADI-R or PARS-TR in accordance with the DSM-5 and ASD diagnostic results assessed in accordance with the M-CHAT-R/F Japanese version. Agreement (Cohen's Kappa coefficient) between the Japanese version of the Infant and Toddler Developmental Screening Questionnaire (ASQ-3) and ASD diagnostic results assessed based on the Japanese version of the M-CHAT-R/F. Reliability:Reliability of the M-CHAT-R/F Japanese version (Cronbach's alpha coefficient)

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Countries

Japan

Contacts

Public ContactYoshiyuki Tachibana

National Center for Child Health and Development Hospital

tachibana-y@ncchd.go.jp03-5494-7120

Outcome results