Clinical Evaluation and Intervention of Developmental Behavioral Diseases Based on Multicenter Cohort Study(CEIDBDBMCS)
NCT ID: NCT06025890
Last Updated: 2023-09-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
2100 participants
INTERVENTIONAL
2022-12-07
2025-12-10
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Cross-sectional Study to Evaluate Speech and Language Development in Chinese Children Aged 2-6 Years
NCT05442229
Development of a New Diagnosis and Intervention Method for Developmental Disorders
NCT01166152
Semantic Learning Deficits in School Age Children With Developmental Language Disorder
NCT04508699
To Evaluate the Efficacy and Safety of 'NDTx-01' in Patients With ASD or SCD
NCT06446193
Written Language Intervention for Adults With Intellectual and Developmental Disabilities
NCT05851937
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
2. Sample size. This study is an intervention study. The language disorder group and the ADHD group had to complete a two-year follow-up and intervention. collect blood samples from 900 cases of language disorder and 1,200 cases of ADHD, and complete an fNIRS task test from 800 ADHD patients. The primary endpoints were language disorder and ADHD.An electronic data acquisition system with a follow-up management module, multi-level authority management and automatic SMS notification function is adopted to build an integrated and standardized multi-center queue data storage and sharing platform. 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.
3. Statistical analysis. By integrating multiple methods such as scale evaluation, behavioral testing, and experience sampling into the tool library, digitization, and interface visualization are realized. Combined with the multi-center cloud data platform, a generalized linear probability model is created, and an early evaluation tool is established. Capturing multimodal neuroimaging features of early childhood using fNIRS; training a hierarchical machine learning scoring model using fused neural features. Based on the classic support vector machine algorithm, the detection model is trained with the post-diagnosis as the result label, and the leave-one-out cross-validation method is used for testing.
4. Ethical matters and data protection. The patients who participated in the study will sign the informed consent (obtained from the guardian). And this study was approved by the local ethics committee. The patient's name will be abbreviated and the research data will be assigned a code then to provide to the researcher. The authorization from parents on the patient's health information remains valid until the study is completed. After that, researchers will delete private information from the study record.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Language Disorder
The language disorder group had to complete a two-year follow-up and intervention. Collect blood samples from 600 cases of language disorder.
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.
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.
Attention Deficit Hyperactivity Disorder
The ADHD group had to complete a two-year follow-up and intervention.Collect blood samples 800 cases of ADHD, and complete a fNIRS task test from 800 ADHD patients.
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.
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.
Normal children
For children aged 1-4, 2 developmental behavioral specialists with associate professor titles or above exclude language barriers.
No interventions assigned to this group
Healthy children
Children aged 3-6, except ADHD with 2 developmental behavioral and/or psychiatrists with associate professor titles or above.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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.
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
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
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.
1 Year
6 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Southeast University, China
OTHER
East China Normal University
UNKNOWN
Shanghai Children's Medical Center
OTHER
Seventh Medical Center of PLA Army General Hospital
OTHER
Chen Li
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Chen Li
Associate Professor, Director
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Li Chen, doctor
Role: STUDY_DIRECTOR
Children's Hospital of Chongqing Medical University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Growth, Development and Mental health of Children and Adolescence Center
Chongqing, Chongqing Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Wolraich ML, Bard DE, Neas B, Doffing M, Beck L. The psychometric properties of the Vanderbilt attention-deficit hyperactivity disorder diagnostic teacher rating scale in a community population. J Dev Behav Pediatr. 2013 Feb;34(2):83-93. doi: 10.1097/DBP.0b013e31827d55c3.
Elvsashagen T, Shadrin A, Frei O, van der Meer D, Bahrami S, Kumar VJ, Smeland O, Westlye LT, Andreassen OA, Kaufmann T. The genetic architecture of the human thalamus and its overlap with ten common brain disorders. Nat Commun. 2021 May 18;12(1):2909. doi: 10.1038/s41467-021-23175-z.
Kim JH, Kim JY, Lee J, Jeong GH, Lee E, Lee S, Lee KH, Kronbichler A, Stubbs B, Solmi M, Koyanagi A, Hong SH, Dragioti E, Jacob L, Brunoni AR, Carvalho AF, Radua J, Thompson T, Smith L, Oh H, Yang L, Grabovac I, Schuch F, Fornaro M, Stickley A, Rais TB, Salazar de Pablo G, Shin JI, Fusar-Poli P. Environmental risk factors, protective factors, and peripheral biomarkers for ADHD: an umbrella review. Lancet Psychiatry. 2020 Nov;7(11):955-970. doi: 10.1016/S2215-0366(20)30312-6.
Chang JP, Su KP, Mondelli V, Pariante CM. Omega-3 Polyunsaturated Fatty Acids in Youths with Attention Deficit Hyperactivity Disorder: a Systematic Review and Meta-Analysis of Clinical Trials and Biological Studies. Neuropsychopharmacology. 2018 Feb;43(3):534-545. doi: 10.1038/npp.2017.160. Epub 2017 Jul 25.
Zhao J, Yu Z, Sun X, Wu S, Zhang J, Zhang D, Zhang Y, Jiang F. Association Between Screen Time Trajectory and Early Childhood Development in Children in China. JAMA Pediatr. 2022 Aug 1;176(8):768-775. doi: 10.1001/jamapediatrics.2022.1630.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CEIDBDBMCS
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.