Autism Spectrum Disorder Clinical Trial
Official title:
Reliability and Validity of Child-Caregiver Interaction Observation Scale (CCIOS) for Diagnosis of Autism Spectrum Disorder
NCT number | NCT04511767 |
Other study ID # | CCIOS2020 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | September 1, 2019 |
Est. completion date | March 28, 2022 |
Verified date | November 2021 |
Source | Children's Hospital of Fudan University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The investigators designed the Child-Caregiver Interaction Observation Scale(CCIOS)to assess social communication behaviors, stereotyped behaviors for children with autism spectrum disorder(ASD) via a 20-min video of interactions between a caregiver and a child. The original CCIOS coding scheme consists 23 items. The score range for each item is 0-4, with higher scores being indicative of more atypical behavior. The aim of the study is to determine items for inclusion in the final CCIOS coding scheme through exploration of item correlations, establish the cutoff score of CCIOS for ASD and evaluate the reliability and validity of CCIOS. The reliability evaluation include test-retest reliability and inter-rater reliability. DSM-5 criterion is used as the gold standard. Validity is assessed by determining the correlation and consistency between CCIOS and DSM-5 criterion.
Status | Completed |
Enrollment | 120 |
Est. completion date | March 28, 2022 |
Est. primary completion date | January 27, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Months to 48 Months |
Eligibility | Inclusion Criteria: - The ASD/GDD/LD diagnosis is made based on the criteria of ASD/GDD/LD in Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) ; - Age 18 months - 48 months; Exclusion Criteria: - Visual, audi-tory and physical disabilities |
Country | Name | City | State |
---|---|---|---|
China | Children's hospital of Fudan University | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital of Fudan University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The scores of CCSIO for ASD/GDD/ID children | CCIOS coding scheme is a 5-point rating scale (0 to 4), with higher scores being indicative of more atypical behavior. The total score can be got by adding up the score of each item. | At enrollment | |
Secondary | The scores of CCSIO for ASD/GDD/ID children (One quarter) | One quarter of subjects will be selected randomly at 1 month after entering the study and take the CCIOS measurement again. CCIOS coding scheme is a 5-point rating scale (0 to 4), with higher scores being indicative of more atypical behavior. The total score can be got by adding up the score of each item. | At 1 month after enrollment |
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