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Completed

NCT Number: NCT04511767

Reliability and Validity of CCISO 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Do not take any interventions

Other

Do not take any interventions

Primary outcomes

  1. The scores of CCSIO for ASD/GDD/ID children

    Time frame: 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 outcomes

  1. The scores of CCSIO for ASD/GDD/ID children (One quarter)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Aug 13, 2020
Registry last updated
Mar 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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