Clinical Evaluation and Intervention of Developmental Behavioral Diseases Based on Multicenter Cohort Study(CEIDBDBMCS)

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.

Conditions

• ADHD
• Language Disorders

Interventions

OTHER

Functional Training.

Based on the modularization of "core ability improvement", "specific ability improvement and ability strategy acquisition", "learning problems and interpersonal relationships", "social adaptation"; and other programs, sometimes combined with computer-aided cognitive training, parenting behavior management training and/or mindfulness training, aerobic exercise and other intervention forms, can achieve personalized functional training intervention for children. Use brain near-infrared imaging technology to capture multimodal neuroimaging features of young children; use high-precision repetitive transcranial direct current stimulation technology to conduct positive neural enhancement and adjustment training on the target brain area. Based on physical therapy stimulation, neuromodulation improves core symptoms in children.

OTHER

Observe.

Children with language disorders and ADHD were recruited at an early age when symptoms first appeared. Professional assessments were conducted to evaluate clinically relevant developmental and cranial nerve function indicators using near-infrared brain imaging technology. Follow-up was conducted for two years, and the outcome indicators were language disorder and attention deficit hyperactivity disorder.

Sponsors & Collaborators

• Southeast University, China

  collaborator OTHER

• East China Normal University

  collaborator UNKNOWN

• Shanghai Children's Medical Center

  collaborator OTHER

• Seventh Medical Center of PLA Army General Hospital

  collaborator OTHER

• Chen Li

  lead OTHER

Principal Investigators

• Li Chen, doctor · Children's Hospital of Chongqing Medical University

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

1 Year

Max Age

6 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-12-07

Primary Completion

2025-06-15

Completion

2025-12-10

Countries

• China

Study Locations