Clinical trial NCT07006948: Multicenter Validation Study on Autism Screening Using a Machine-assisted System
Official title: Multicenter Validation Study on the Effectiveness of a Machine-Assisted System for Early Screening of Autism
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Autism Spectrum Disorder
Early Developmental Impairment
Language Development Disorders
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
Collaborators: name: Harbin Institute of Technology, Shenzhen
name: Kunshan City Maternal and Child Health
name: Hefei First People's Hospital
name: Ningbo Women & Children's Hospital
name: Xiamen Children's Hospital
name: Chengdu Women's and Children's Central Hospital
name: Liuzhou Maternity and Child Healthcare Hospital
name: Xian Children's Hospital
name: Dehong People's Hospital
name: The Sixth Affiliated Hospital of Harbin Medical University
First posted: 2025-06-05
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The diagnostic accuracy study will be performed in children with ASD, GDD, LD, and healthy, typically developing children aged between 1.5 to 2.5 years old.

Brief summary: The goal of this observational study is to assess the effectiveness of a machine-assisted system for early screening of autism. The main questions it aims to answer are:

* Does the machine-assisted system including 5 main behavioral paradigms identify toddlers with autism from those with other neurodevelopmental disorders and typical development?
* Are there any differences in the early symptoms of autism among toddlers over the whole mainland China? Participants will receive some developmental and social communicational evaluations for clinical diagnoses. They will also receive the behavior evaluations of the machine-assisted system. The above evaluations will be performed just once.

Detailed description: The current study is a diagnostic accuracy study. In total, 1000 Toddlers with autism spectrum disorder, global developmental delay, language disorder, and typical development (n=250 for each group) will be recruited in this study. The gold standard of the diagnosis of autism spectrum disorder will be the clinical diagnosis from developmental and behavioral pediatricians, and the diagnoses will be confirmed by Autism Diagnostic Observation Schedule-2nd edition and Griffiths Development Scales-Chinese edition(GDS-C). The diagnostic accuracy of the machine-assisted system for early screening of autism will be evaluated.

Eligibility criteria: ASD group：

Inclusion Criteria:

1. Children diagnosed with ASD according to a clinical judgement based on the criteria of ASD in DSM-5 and further confirmed with ADOS-2;
2. Ages 1.5-2.5 years;
3. Parents/caregivers understand the content of the study and agree to participate in.

GDD group：

Inclusion Criteria:

1. Age 1.5-2.5 years, gestational age 37-42 weeks, birth weight 2500-4000g;
2. Clinically diagnosed with GDD (Global Developmental Delay) according to the DSM-V diagnostic criteria, with a Griffiths Development Scales-Chinese edition(GDS-C) assessment showing a Developmental Quotient (DQ) ≤75 in two or more domains;
3. Those who did not meet the initial screening positivity criteria for ASD (Autism Spectrum Disorder) using M-CHAT-R/F.

LD group：

Inclusion Criteria:

1. Age 1.5-2.5 years, gestational age 37-42 weeks, birth weight 2500-4000 g;
2. Clinically diagnosed with LD (Language Disorder) according to the DSM-V diagnostic criteria, with a Developmental Quotient (DQ) ≤75 in the language domain of the Griffiths Development Scales-Chinese edition(GDS-C) and DQ \>75 in all other domains;
3. Those who did not meet the initial screening positivity criteria for ASD (Autism Spectrum Disorder) assessed by M-CHAT-R/F

Exclusion Criteria for ASD, GDD, and LD groups:

1. Rett Syndrome, Fragile X Syndrome, Angelman Syndrome, Prader-Willi Syndrome, tuberous sclerosis, and other syndromes caused by known genetic defects or inherited metabolic diseases;
2. Children with brain injuries, specific chronic or congenital diseases.
3. The gestational age is less than 37 weeks, or the birth weight is lower than 2500g.

TD group：

Inclusion Criteria:

1. Healthy, typically developing toddlers aged 1.5-2.5 years ;
2. gestational age of 37-42 weeks, birth weight of 2500-4000 g;
3. Developmental Quotients(DQs) are greater than 75 in all domains of theGriffiths Development Scales-Chinese edition(GDS-C);
4. Screened negative by M-CHAT-R/F screening for autism spectrum disorder (ASD).

Exclusion Criteria:

Children with neurodevelopmental disorders (e.g., developmental delay, language impairment), neurological conditions (e.g., epilepsy, tuberous sclerosis), or other severe chronic diseases were excluded.

Primary outcomes:
measure: Total Score of 5 main social behaviors
timeFrame: The assessment will be performed during 1.5 to 2.5 years old.
measure: Clinical diagnoses
timeFrame: The diagnoses will be made during 1.5 to 2.5 years old.
measure: Scores of Autism Diagnostic Observation Schedule-2nd edition(ADOS-2)
timeFrame: The assessment will be performed during 1.5 to 2.5 years old.
measure: development quotient development quotient Development quotients (DQs) of Griffiths Developmental Scales-Chinese edition(GDS-C)
timeFrame: The assessment will be performed during 1.5 to 2.5 years old.
Secondary outcomes:
Other outcomes:
Locations:
city: Hefei
country: China
facility: Hefei First People's Hospital
state: Anhui
city: Xiamen
country: China
facility: Xiamen Children's Hospital
state: Fujian
city: Liuzhou
country: China
facility: Liuzhou Maternity and child Healthcare Hospital
state: Guangxi
city: Harbin
country: China
facility: The Sixth Affiliated Hospital of Harbin Medical University
state: Helongjiang
city: Kunshan
country: China
facility: Kunshan Maternal and Child Health Care Hospital
state: Jiangsu
city: Xi'an
country: China
facility: Xi'an Children's Hospital
state: Shaanxi
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
state: Shanghai
city: Chengdu
country: China
facility: Chengdu Women's and Children's Central Hospital
state: Sichuan
city: Dehong
country: China
facility: Dehong People's Hospital
state: Yunnan
city: Ningbo
country: China
facility: Ningbo Women and Children's Hospital
state: Zhejiang
Study officials:
affiliation: Children's Hospital of Fudan University
name: Xiu Xu
role: PRINCIPAL_INVESTIGATOR
References: