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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date November 2021
Source Children's Hospital of Fudan University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

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 investigators conduct this study 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. It is of importance to accurately distinguish children with ASD from those with Global Developmental Delay (GDD) and Language Disorder (LD) without ASD, sometimes, it's very difficult in children with mental ages below 2 years. This differentiation has strong implications for treatment recommendations and may also inform long-term prognosis. In this study, The investigators planned to recruit 60 children with ASD and 60 children with GDD/LD aged from 18 months to 48 months. 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Do not take any interventions
Do not take any interventions

Locations

Country Name City State
China Children's hospital of Fudan University Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Children's Hospital of Fudan University

Country where clinical trial is conducted

China, 

Outcome

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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