Reliability and Validity of CCISO for Diagnosis of Autism Spectrum Disorder

NCT04511767 | Completed

• 1 other identifier: CCIOS2020
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder; Global Developmental Delay; Language Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  At 1 month after enrollment

Study Arms (3)

ASD group

the autism spectrum disorder group

Other: Do not take any interventions

GDD group

the global developmental disorder group

Other: Do not take any interventions

LD group

the language disorder group

Other: Do not take any interventions

Interventions

Do not take any interventions OTHER

Do not take any interventions

ASD group; GDD group; LD group

Eligibility Criteria

• Age: 18 Months - 48 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

ASD/GDD/LD children are from development behavior clinic

You may qualify if:

• 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;

You may not qualify if:

• Visual, audi-tory and physical disabilities

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Study Sites (1)

Children's hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Learning Disabilities; Language Disorders

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Xiu Xu, Doctor

  Children's Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

• Qiong Xu, Doctor

  Children's Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2020
• First Posted: August 13, 2020
• Study Start: September 1, 2019
• Primary Completion: January 27, 2022
• Study Completion: March 28, 2022
• Last Updated: March 31, 2022

Record last verified: 2021-11

Locations

CN (1)