Reliability and Validity of CCISO for Diagnosis of Autism Spectrum Disorder

NCT ID: NCT04511767

Last Updated: 2022-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-01

Study Completion Date

2022-03-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Autism Spectrum Disorder Global Developmental Delay Language Disorder

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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ASD group

the autism spectrum disorder group

Do not take any interventions

Intervention Type OTHER

Do not take any interventions

GDD group

the global developmental disorder group

Do not take any interventions

Intervention Type OTHER

Do not take any interventions

LD group

the language disorder group

Do not take any interventions

Intervention Type OTHER

Do not take any interventions

Interventions

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Do not take any interventions

Do not take any interventions

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Months

Maximum Eligible Age

48 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital of Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xiu Xu, Doctor

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Fudan University

Qiong Xu, Doctor

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Fudan University

Locations

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Children's hospital of Fudan University

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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CCIOS2020

Identifier Type: -

Identifier Source: org_study_id

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