Reliability and Validity of CCISO for Diagnosis of Autism Spectrum Disorder

Sponsor

Children's Hospital of Fudan University (Other)

Overall Status

Completed

CT.gov ID

NCT04511767

Collaborator

(none)

120

Enrollment

Location

30.9

Actual Duration (Months)

3.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Autism Spectrum Disorder Global Developmental Delay Language Disorder	Other: Do not take any interventions

Detailed 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.

Study Design

Study Type:

Observational

Actual Enrollment :

120 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

Reliability and Validity of Child-Caregiver Interaction Observation Scale (CCIOS) for Diagnosis of Autism Spectrum Disorder

Actual Study Start Date :

Sep 1, 2019

Actual Primary Completion Date :

Jan 27, 2022

Actual Study Completion Date :

Mar 28, 2022

Arms and Interventions

Arm	Intervention/Treatment
ASD group the autism spectrum disorder group	Other: Do not take any interventions Do not take any interventions
GDD group the global developmental disorder group	Other: Do not take any interventions Do not take any interventions
LD group the language disorder group	Other: Do not take any interventions Do not take any interventions

Arm

Intervention/Treatment

ASD group

the autism spectrum disorder group

Other: Do not take any interventions

Do not take any interventions

GDD group

the global developmental disorder group

Other: Do not take any interventions

Do not take any interventions

LD group

the language disorder group

Other: Do not take any interventions

Do not take any interventions

Outcome Measures

Primary Outcome Measures

The scores of CCSIO for ASD/GDD/ID children [At enrollment]
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.

Secondary Outcome Measures

The scores of CCSIO for ASD/GDD/ID children (One quarter) [At 1 month after enrollment]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Months to 48 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's hospital of Fudan University	Shanghai	Shanghai	China	201102

Sponsors and Collaborators

Children's Hospital of Fudan University

Investigators

Principal Investigator: Xiu Xu, Doctor, Children's Hospital of Fudan University
Principal Investigator: Qiong Xu, Doctor, Children's Hospital of Fudan University