Autism Spectrum DisorderNCT04511767
Reliability and Validity of CCISO for Diagnosis of Autism Spectrum Disorder
An observational study of Autism Spectrum Disorder and Global Developmental Delay, run by Children's Hospital of Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 48 months
- Conditions the study is for
- Autism Spectrum Disorder, Global Developmental Delay, Language Disorder
- What is being tested?
- Do not take any interventions
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2019to 28 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 48 months
- All sexes
- No healthy volunteers
- Child
Study population: ASD/GDD/LD children are from development behavior clinic
Who may be able to join
- 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;
Who cannot join
- Visual, audi-tory and physical disabilities
Trial locations and contacts
1 site in 1 country.
China1 site
Children's hospital of Fudan University
Shanghai, Shanghai Municipality, 201102
About this study
Official title: 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.
Read the 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.
- Being tested
- Do not take any interventions
- Medical subject headings
- Autism Spectrum Disorder, Learning Disabilities, Language Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Do not take any interventionsOther
Do not take any interventions
| Study group | Role | What they receive |
|---|---|---|
| ASD group | the autism spectrum disorder group Receives: Other: Do not take any interventions | |
| GDD group | the global developmental disorder group Receives: Other: Do not take any interventions | |
| LD group | the language disorder group Receives: Other: Do not take any interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At enrollment
Secondary outcomes (1)
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.
Measured: At 1 month after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2020
- Study start1 Sep 2019
- Primary completion27 Jan 2022
- Study completion28 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiu Xu, Doctor, Principal investigator, Children's Hospital of Fudan UniversityQiong Xu, Doctor, Principal investigator, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04511767
- Sponsor's protocol ID
- CCIOS2020
- Status last verified
- Nov 2021
- First submitted
- 2 Aug 2020
- Last updated
- 31 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Validity of Child-Caregiver Interaction Observation Scale (CCIOS) for Diagnosis of Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT04511767
- Acronym / sponsor ID
- CCIOS2020
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 27 Jan 2022 (actual)
- Study completion
- 28 Mar 2022 (actual)
- First posted
- 13 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ASD group | – | Other: Do not take any interventionsthe autism spectrum disorder group |
| GDD group | – | Other: Do not take any interventionsthe global developmental disorder group |
| LD group | – | Other: Do not take any interventionsthe language disorder group |
Who may qualify
- Ages
- 18 to 48 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- ASD/GDD/LD children are from development behavior clinic
Key inclusion criteria (2 listed)
- 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;
Key exclusion criteria (1 listed)
- Visual, audi-tory and physical disabilities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Do not take any interventionsDo not take any interventions | Other | ASD group, GDD group, LD group |
Primary outcome
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.
1 secondary outcome
The scores of CCSIO for ASD/GDD/ID children (One quarter)
Time frame: At 1 month after enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiu Xu, Doctor principal investigator
Children's Hospital of Fudan University
Qiong Xu, Doctor principal investigator
Children's Hospital of Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder and Global Developmental Delay, run by Children's Hospital of Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The scores of CCSIO for ASD/GDD/ID children (time frame: At enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.