Early Clinical Evaluation and Intervention of Developmental Behavioral Diseases Based on Multicenter Cohort Study
Trial ID: NCT06025890
Status: UNKNOWN
Study type: INTERVENTIONAL
Phase: NA
Start date: 2022-12-07
Completion date: 2025-12-10
Sponsor: Chen Li
Collaborators: Southeast University, China; East China Normal University; Shanghai Children's Medical Center; Seventh Medical Center of PLA Army General Hospital
Conditions: ADHD; Language Disorders
Interventions: Functional Training.; Observe.
Locations: Growth, Development and Mental health of Children and Adolescence Center
Countries: China
Enrollment: 2100
Age range: 1 Year - 6 Years
Sex: ALL

Summary:
Diagnosis of Language Disorder and Attention Deficit Hyperactivity Disorder (ADHD) is difficult for several reasons. This study aims to establish a Chinese multi-center cohort for the early diagnosis of language disorder and ADHD in children, develop appropriate early assessment tools and formulate intervention programs and standards for early functional training. Based on a national multi-center research team with Chongqing, Shanghai, and Beijing as the core areas, the investigators established a specific disease cohort for early diagnosis of language disorder and ADHD: a specific disease cohort with language disorder (900 cases) who were 1-3 years when the follow-up started, and 4-6 years old at the end of follow-up; a specific cohort with ADHD (1200 cases) who were 3-6 years when the follow-up started, and 7-9 years old at the end of follow-up. At the time of enrollment, professional assessments such as clinical development indicators and neurological function indicators were assessed using functional near-infrared spectroscopy(fNIRS). Outcome measures were speech impairment and hyperactivity. Blood samples were taken from 600 speech-impaired patients and 800 ADHD patients. Of these, 800 ADHD subjects completed an fNIRS imaging task. Build an intelligent brain image big data analysis system to realize early quality control, processing, and analysis of brain images, and study objective markers for early disease detection. The investigators can use machine learning and applications for early diagnosis, developing big data analysis tools such as integrated clinical assessment and brain imaging, promoting comprehensive clinical assessment and big data analysis tools systems such as brain imaging, and building assessment tools for language disorders and ADHD. Through the implementation and results of the multi-center special disease cohort platform, evidence-based medical evidence is collected to form clinical standards and guidelines.

Eligibility criteria:
1\. Language disorder

Inclusion criteria:

1. Language disorder(n=900): This study included children between the ages of 1-4 who were evaluated for potential language disorder by two developmental behavioral specialists holding the title of associate professor or higher.
2. Control group(n=100): This study included children between the ages of 1-4 who were exclude with language disorder by two developmental behavioral specialists with the title of associate professor or higher.

Exclusion criteria:

1. Children with a history of language development delay or language disorder intervention treatment.
2. DQ score below 85.
3. (3) Patients with organic diseases of the nervous system, epilepsy, autism spectrum disorder, global developmental delay, and hearing impairment, and/or people caring for patients with mental illness, hearing impairment,language disoeder.

2.ADHD

Inclusion criteria:

1. ADHD(n=1200): This study included children between the ages of 3-6 who were evaluated for potential ADHD by two developmental behavioral and/or psychiatrists with the rank of associate professor or higher.
2. Control group(n=100):This study included children between the ages of 1-4 who were exclude with ADHD by two developmental behavioral and/or psychiatrists with the rank of associate professor or higher.

Exclusion criteria:

1. Children with ADHD intervention treatment.
2. DQ score lower than 85, or IQ score lower than 80.
3. Patients with organic diseases of the nervous system, epilepsy, autism spectrum disorder, global developmental delay, mental retardation, atopic dermatitis, asthma, hearing impairment or visual impairment.

Outcomes:
Changes in the Gesell Developmental Scale(GDS).; Changes in Infants-Junior High School Students'Social Development Screening Test.; Changes in Dream-Infant-Toddler Language Communication Screening（DREAM-IT-S）; Changes in Dreaming Children's Language Standardized Assessment (DREAM-C); Changes in Wechsler Preschool and Primary Scale of Intelligence, Fourth Edition (WPPSI-IV) .; Changes in Wechsler Intelligence Scale for Children, Fourth Edition (WISC-IV).; Changes in Child Behavior Checklist (CBCL); Changes in the Vanderbilt Assessment Scale; Changes in Questionnaire-Children with Difficulties.