Reliability and Validity of CCISO for Diagnosis of Autism Spectrum Disorder

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

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.

Study Overview

• Status: Completed
• Conditions: Autism Spectrum Disorder; Global Developmental Delay; Language Disorder
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 201102
      • Children's Hospital of Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 4 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

ASD/GDD/LD children are from development behavior clinic

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Children's Hospital of Fudan University
• Investigators: Principal Investigator: Qiong Xu, Doctor, Children's Hospital of Fudan University

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2019
• Primary Completion (ACTUAL): January 27, 2022
• Study Completion (ACTUAL): March 28, 2022

Study Registration Dates

• First Submitted: August 2, 2020
• First Submitted That Met QC Criteria: August 11, 2020
• First Posted (ACTUAL): August 13, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 30, 2022
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Communication Disorders; Disease; Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Language Disorders
• Other Study ID Numbers: CCIOS2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No