xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06025890</url>
    </required_header>
    <id_info>
      <org_study_id>CEIDBDBMCS</org_study_id>
      <nct_id>NCT06025890</nct_id>
    </id_info>
    <brief_title>Clinical Evaluation and Intervention of Developmental Behavioral Diseases Based on Multicenter Cohort Study(CEIDBDBMCS)</brief_title>
    <acronym>CEIDBDBMCS</acronym>
    <official_title>Early Clinical Evaluation and Intervention of Developmental Behavioral Diseases Based on Multicenter Cohort Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Chen Li</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Southeast University, China</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>East China Normal University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Shanghai Children's Medical Center</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Seventh Medical Center of PLA Army General Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Children's Hospital of Chongqing Medical University</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Diagnosis of Language Disorder and Attention Deficit Hyperactivity Disorder (ADHD) is&#xD;
        difficult for several reasons. This study aims to establish a Chinese multi-center cohort for&#xD;
        the early diagnosis of language disorder and ADHD in children, develop appropriate early&#xD;
        assessment tools and formulate intervention programs and standards for early functional&#xD;
        training. Based on a national multi-center research team with Chongqing, Shanghai, and&#xD;
        Beijing as the core areas, the investigators established a specific disease cohort for early&#xD;
        diagnosis of language disorder and ADHD: a specific disease cohort with language disorder&#xD;
        (900 cases) who were 1-3 years when the follow-up started, and 4-6 years old at the end of&#xD;
        follow-up; a specific cohort with ADHD (1200 cases) who were 3-6 years when the follow-up&#xD;
        started, and 7-9 years old at the end of follow-up. At the time of enrollment, professional&#xD;
        assessments such as clinical development indicators and neurological function indicators were&#xD;
        assessed using functional near-infrared spectroscopy(fNIRS). Outcome measures were speech&#xD;
        impairment and hyperactivity. Blood samples were taken from 600 speech-impaired patients and&#xD;
        800 ADHD patients. Of these, 800 ADHD subjects completed an fNIRS imaging task. Build an&#xD;
        intelligent brain image big data analysis system to realize early quality control,&#xD;
        processing, and analysis of brain images, and study objective markers for early disease&#xD;
        detection. The investigators can use machine learning and applications for early diagnosis,&#xD;
        developing big data analysis tools such as integrated clinical assessment and brain imaging,&#xD;
        promoting comprehensive clinical assessment and big data analysis tools systems such as brain&#xD;
        imaging, and building assessment tools for language disorders and ADHD. Through the&#xD;
        implementation and results of the multi-center special disease cohort platform,&#xD;
        evidence-based medical evidence is collected to form clinical standards and guidelines.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        1. Procedures. From December 2022 to May 2024, the research team completed the collection&#xD;
             and follow-up of 900 cases of language disorder and 1,200 cases of ADHD, and included&#xD;
             them in the language disorder and ADHD cohort case collection database.From June 2024 to&#xD;
             November 2024, 900 children with language disorders and 1,200 children with ADHD will be&#xD;
             followed; blood samples will be collected from 600 children with language disorders and&#xD;
             800 children with ADHD; 800 children with ADHD will be completed using the fNIRS task&#xD;
             test. From December 2024 to November 2025, complete the follow-up of 900 cases of&#xD;
             language disorder and 1,200 cases of ADHD, complete the development of an early&#xD;
             assessment tool set suitable for the Chinese children with language disorders and ADHD,&#xD;
             complete the formulation of intervention plans, establish a unified standard, and&#xD;
             extended the results to 50 hospitals.&#xD;
  &#xD;
          2. Sample size. This study is an intervention study. The language disorder group and the&#xD;
             ADHD group had to complete a two-year follow-up and intervention. collect blood samples&#xD;
             from 900 cases of language disorder and 1,200 cases of ADHD, and complete an fNIRS task&#xD;
             test from 800 ADHD patients. The primary endpoints were language disorder and ADHD.An&#xD;
             electronic data acquisition system with a follow-up management module, multi-level&#xD;
             authority management and automatic SMS notification function is adopted to build an&#xD;
             integrated and standardized multi-center queue data storage and sharing platform. Based&#xD;
             on the modularization of &quot;core ability improvement&quot;, &quot;specific ability improvement and&#xD;
             ability strategy acquisition&quot;, &quot;learning problems and interpersonal relationships&quot;,&#xD;
             &quot;social adaptation&quot;; and other programs, sometimes combined with computer-aided&#xD;
             cognitive training, parenting behavior management training and/or mindfulness training,&#xD;
             aerobic exercise and other intervention forms can achieve personalized functional&#xD;
             training intervention for children. Use brain near-infrared imaging technology to&#xD;
             capture multimodal neuroimaging features of young children; use high-precision&#xD;
             repetitive transcranial direct current stimulation technology to conduct positive neural&#xD;
             enhancement and adjustment training on the target brain area. Based on physical therapy&#xD;
             stimulation, neuromodulation improves core symptoms in children.&#xD;
  &#xD;
          3. Statistical analysis. By integrating multiple methods such as scale evaluation,&#xD;
             behavioral testing, and experience sampling into the tool library, digitization, and&#xD;
             interface visualization are realized. Combined with the multi-center cloud data&#xD;
             platform, a generalized linear probability model is created, and an early evaluation&#xD;
             tool is established. Capturing multimodal neuroimaging features of early childhood using&#xD;
             fNIRS; training a hierarchical machine learning scoring model using fused neural&#xD;
             features. Based on the classic support vector machine algorithm, the detection model is&#xD;
             trained with the post-diagnosis as the result label, and the leave-one-out&#xD;
             cross-validation method is used for testing.&#xD;
  &#xD;
          4. Ethical matters and data protection. The patients who participated in the study will&#xD;
             sign the informed consent (obtained from the guardian). And this study was approved by&#xD;
             the local ethics committee. The patient's name will be abbreviated and the research data&#xD;
             will be assigned a code then to provide to the researcher. The authorization from&#xD;
             parents on the patient's health information remains valid until the study is completed.&#xD;
             After that, researchers will delete private information from the study record.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">December 7, 2022</start_date>
    <completion_date type="Anticipated">December 10, 2025</completion_date>
    <primary_completion_date type="Anticipated">June 15, 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Collect blood samples from 600 cases of language disorder and 800 cases of ADHD, and complete an fNIRS task test from 800 ADHD patients. Based on the modularization of &quot;core ability improvement&quot;, &quot;specific ability improvement and ability strategy acquisition&quot;, &quot;learning problems and interpersonal relationships&quot;, &quot;social adaptation&quot;; 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.</intervention_model_description>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Changes in the Gesell Developmental Scale(GDS).</measure>
      <time_frame>2 years</time_frame>
      <description>Children are followed up every 6 months, and at each follow-up point, the GDS is used to assess children and obtain their comprehensive scores in various developmental domains. These domains may include motor development, gross and fine motor coordination, language and communication, cognitive and thinking abilities. The score range for language development is 0-100, where a higher score indicates a more excellent level of development in the field, in line with age expectations, while a lower score may indicate a lag or issues in the development of that field.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Changes in Infants-Junior High School Students'Social Development Screening Test.</measure>
      <time_frame>2 years</time_frame>
      <description>The scores obtained from the Infant to Middle School Student Social Life Skills Scale (S-M) at each 3-month follow-up reflect the social interaction, communication skills, and adaptation to social environments of the participants at different follow-up stages. The score range for the Infants-Junior High School Students' Social Development Screening Test varies depending on the specific assessment tool used. Generally, the scores may range from 0 to 100 or may be presented in percentile ranks. In general, a higher score indicates that the individual's social development is more advanced and aligned with age expectations. On the other hand, a lower score might suggest developmental lags or challenges in social skills.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Changes in Dream-Infant-Toddler Language Communication Screening（DREAM-IT-S）</measure>
      <time_frame>2 years</time_frame>
      <description>The scores obtained from the Dream-Infant-Toddler Language Communication Screening (DREAM-IT-S) administered at each 3-month follow-up reflect the language abilities of children.The total score range of DREAM-IT-S is between 0 and 10, where a lower score indicates better language communication ability, while a higher score suggests potential delays or obstacles in language development.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Changes in Dreaming Children's Language Standardized Assessment (DREAM-C)</measure>
      <time_frame>2 years</time_frame>
      <description>The scores obtained from the Dream-Infant-Toddler Language Communication Screening (DREAM-IT-S) and Dreaming Children's Language Standardized Assessment (DREAM-C) administered at each 3-month follow-up reflect the language abilities of children. The total score range of DREAM-C can vary depending on the specific assessment criteria, but it typically falls within a predetermined range. The exact range depends on the design of the assessment tool and scoring system, but generally, it may be scored on a scale from 0 to 100 or other values. Lower scores indicate stronger language abilities and effective communication skills, while higher scores may suggest potential language development delays or communication barriers.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Changes in Wechsler Preschool and Primary Scale of Intelligence, Fourth Edition (WPPSI-IV) .</measure>
      <time_frame>2 years</time_frame>
      <description>Conducting follow-up assessments every 6 months using the Wechsler Preschool and Primary Scale of Intelligence, Fourth Edition (WPPSI-IV) scores reflect the cognitive and intellectual development of children at different follow-up points. The total score range of WPPSI-IV is in percentage (from 0 to 100), where higher scores indicate stronger abilities in the corresponding domains.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Changes in Wechsler Intelligence Scale for Children, Fourth Edition (WISC-IV).</measure>
      <time_frame>2 years</time_frame>
      <description>Conducting follow-up assessments every 6 months using the Wechsler Intelligence Scale for Children, Fourth Edition (WISC-IV) scores reflect the cognitive and intellectual development of children at different follow-up points. The total score range of WISC-IV is in percentage (from 0 to 100), where higher scores indicate stronger abilities in the corresponding domains.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Changes in Child Behavior Checklist (CBCL)</measure>
      <time_frame>2 years</time_frame>
      <description>Conducting follow-up assessments every 3 months using the Child Behavior Checklist (CBCL) scores reflects the emotional and behavioral issues of children at different follow-up points.The scores on the CBCL typically range from 0 to 100, and higher scores may indicate that children are experiencing difficulties in behavior and emotional problems.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Changes in the Vanderbilt Assessment Scale</measure>
      <time_frame>2 yaers</time_frame>
      <description>The use of the Vanderbilt Assessment Scale scores in follow-up visits every three months reflects the ADHD symptomatology of children at different follow-up milestones. The total score of the Vanderbilt Assessment Scale can range from 0 to 54. A higher score indicates a greater likelihood of ADHD symptoms or difficulties with attention and behavior.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Changes in Questionnaire-Children with Difficulties.</measure>
      <time_frame>2 years</time_frame>
      <description>Follow-up assessments every 3 months, using the Questionnaire-Children with Difficulties (QCD) scores, reflect children's psychological issues and behavioral difficulties. The scoring range of the QCD questionnaire may vary depending on the specific version or rating system. For example, certain rating systems may categorize scores into levels of severity such as mild, moderate, or severe difficulties. Higher scores may indicate higher levels of psychological difficulties or disorders. Conversely, lower scores may suggest fewer problems or mild manifestations.</description>
    </primary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">2100</enrollment>
    <condition>ADHD</condition>
    <condition>Language Disorders</condition>
    <arm_group>
      <arm_group_label>Language Disorder</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The language disorder group had to complete a two-year follow-up and intervention. Collect blood samples from 600 cases of language disorder.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Attention Deficit Hyperactivity Disorder</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Normal children</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>For children aged 1-4, 2 developmental behavioral specialists with associate professor titles or above exclude language barriers.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Healthy children</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Children aged 3-6, except ADHD with 2 developmental behavioral and/or psychiatrists with associate professor titles or above.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Functional Training.</intervention_name>
      <description>Based on the modularization of &quot;core ability improvement&quot;, &quot;specific ability improvement and ability strategy acquisition&quot;, &quot;learning problems and interpersonal relationships&quot;, &quot;social adaptation&quot;; 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.</description>
      <arm_group_label>Attention Deficit Hyperactivity Disorder</arm_group_label>
      <arm_group_label>Language Disorder</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Observe.</intervention_name>
      <description>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.</description>
      <arm_group_label>Attention Deficit Hyperactivity Disorder</arm_group_label>
      <arm_group_label>Language Disorder</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          1. Language disorder&#xD;
  &#xD;
          Inclusion criteria:&#xD;
  &#xD;
            1. Language disorder(n=900): This study included children between the ages of 1-4 who&#xD;
               were evaluated for potential language disorder by two developmental behavioral&#xD;
               specialists holding the title of associate professor or higher.&#xD;
  &#xD;
            2. Control group(n=100): This study included children between the ages of 1-4 who were&#xD;
               exclude with language disorder by two developmental behavioral specialists with the&#xD;
               title of associate professor or higher.&#xD;
  &#xD;
          Exclusion criteria:&#xD;
  &#xD;
            1. Children with a history of language development delay or language disorder&#xD;
               intervention treatment.&#xD;
  &#xD;
            2. DQ score below 85.&#xD;
  &#xD;
            3. (3) Patients with organic diseases of the nervous system, epilepsy, autism spectrum&#xD;
               disorder, global developmental delay, and hearing impairment, and/or people caring for&#xD;
               patients with mental illness, hearing impairment,language disoeder.&#xD;
  &#xD;
          2.ADHD&#xD;
  &#xD;
          Inclusion criteria:&#xD;
  &#xD;
            1. ADHD(n=1200): This study included children between the ages of 3-6 who were evaluated&#xD;
               for potential ADHD by two developmental behavioral and/or psychiatrists with the rank&#xD;
               of associate professor or higher.&#xD;
  &#xD;
            2. Control group(n=100):This study included children between the ages of 1-4 who were&#xD;
               exclude with ADHD by two developmental behavioral and/or psychiatrists with the rank&#xD;
               of associate professor or higher.&#xD;
  &#xD;
          Exclusion criteria:&#xD;
  &#xD;
            1. Children with ADHD intervention treatment.&#xD;
  &#xD;
            2. DQ score lower than 85, or IQ score lower than 80.&#xD;
  &#xD;
            3. Patients with organic diseases of the nervous system, epilepsy, autism spectrum&#xD;
               disorder, global developmental delay, mental retardation, atopic dermatitis, asthma,&#xD;
               hearing impairment or visual impairment.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>1 Year</minimum_age>
      <maximum_age>6 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Li Chen, doctor</last_name>
      <role>Study Director</role>
      <affiliation>Children's Hospital of Chongqing Medical University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Li Chen, doctor</last_name>
      <phone>136 7762 0103</phone>
      <phone_ext>+86</phone_ext>
      <email>chenli2012@126.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Growth, Development and Mental health of Children and Adolescence Center</name>
        <address>
          <city>Chongqing</city>
          <state>Chongqing</state>
          <zip>400014</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Li Chen, MD</last_name>
        <phone>(+86)136 7762 0103</phone>
        <phone_ext>+86</phone_ext>
        <email>chenli2012@126.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <reference>
      <citation>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.</citation>
      <PMID>23363973</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>34006833</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>33069318</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>28741625</PMID>
    </reference>
    <reference>
      <citation>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. Erratum In: JAMA Pediatr. 2022 Aug 1;176(8):829.</citation>
      <PMID>35666518</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>January 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Children's Hospital of Chongqing Medical University</investigator_affiliation>
      <investigator_full_name>Chen Li</investigator_full_name>
      <investigator_title>Associate Professor, Director</investigator_title>
    </responsible_party>
    <keyword>ADHD</keyword>
    <keyword>Language Disorder</keyword>
    <keyword>Artificial Intelligence</keyword>
    <keyword>fNIRS</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Language Disorders</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Data is confidential during the study.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06025890
  org study id: CEIDBDBMCS
  nct id: NCT06025890
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  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.
  1. Procedures. From December 2022 to May 2024, the research team completed the collection
             and follow-up of 900 cases of language disorder and 1,200 cases of ADHD, and included
             them in the language disorder and ADHD cohort case collection database.From June 2024 to
             November 2024, 900 children with language disorders and 1,200 children with ADHD will be
             followed; blood samples will be collected from 600 children with language disorders and
             800 children with ADHD; 800 children with ADHD will be completed using the fNIRS task
             test. From December 2024 to November 2025, complete the follow-up of 900 cases of
             language disorder and 1,200 cases of ADHD, complete the development of an early
             assessment tool set suitable for the Chinese children with language disorders and ADHD,
             complete the formulation of intervention plans, establish a unified standard, and
             extended the results to 50 hospitals.
  
          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.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  intervention model description: Collect blood samples from 600 cases of language disorder and 800 cases of ADHD, and complete an fNIRS task test from 800 ADHD patients. 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.
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: Changes in the Gesell Developmental Scale(GDS).
  time frame: 2 years
  description: Children are followed up every 6 months, and at each follow-up point, the GDS is used to assess children and obtain their comprehensive scores in various developmental domains. These domains may include motor development, gross and fine motor coordination, language and communication, cognitive and thinking abilities. The score range for language development is 0-100, where a higher score indicates a more excellent level of development in the field, in line with age expectations, while a lower score may indicate a lag or issues in the development of that field.
  measure: Changes in Infants-Junior High School Students'Social Development Screening Test.
  time frame: 2 years
  description: The scores obtained from the Infant to Middle School Student Social Life Skills Scale (S-M) at each 3-month follow-up reflect the social interaction, communication skills, and adaptation to social environments of the participants at different follow-up stages. The score range for the Infants-Junior High School Students' Social Development Screening Test varies depending on the specific assessment tool used. Generally, the scores may range from 0 to 100 or may be presented in percentile ranks. In general, a higher score indicates that the individual's social development is more advanced and aligned with age expectations. On the other hand, a lower score might suggest developmental lags or challenges in social skills.
  measure: Changes in Dream-Infant-Toddler Language Communication Screening（DREAM-IT-S）
  time frame: 2 years
  description: The scores obtained from the Dream-Infant-Toddler Language Communication Screening (DREAM-IT-S) administered at each 3-month follow-up reflect the language abilities of children.The total score range of DREAM-IT-S is between 0 and 10, where a lower score indicates better language communication ability, while a higher score suggests potential delays or obstacles in language development.
  measure: Changes in Dreaming Children's Language Standardized Assessment (DREAM-C)
  time frame: 2 years
  description: The scores obtained from the Dream-Infant-Toddler Language Communication Screening (DREAM-IT-S) and Dreaming Children's Language Standardized Assessment (DREAM-C) administered at each 3-month follow-up reflect the language abilities of children. The total score range of DREAM-C can vary depending on the specific assessment criteria, but it typically falls within a predetermined range. The exact range depends on the design of the assessment tool and scoring system, but generally, it may be scored on a scale from 0 to 100 or other values. Lower scores indicate stronger language abilities and effective communication skills, while higher scores may suggest potential language development delays or communication barriers.
  measure: Changes in Wechsler Preschool and Primary Scale of Intelligence, Fourth Edition (WPPSI-IV) .
  time frame: 2 years
  description: Conducting follow-up assessments every 6 months using the Wechsler Preschool and Primary Scale of Intelligence, Fourth Edition (WPPSI-IV) scores reflect the cognitive and intellectual development of children at different follow-up points. The total score range of WPPSI-IV is in percentage (from 0 to 100), where higher scores indicate stronger abilities in the corresponding domains.
  measure: Changes in Wechsler Intelligence Scale for Children, Fourth Edition (WISC-IV).
  time frame: 2 years
  description: Conducting follow-up assessments every 6 months using the Wechsler Intelligence Scale for Children, Fourth Edition (WISC-IV) scores reflect the cognitive and intellectual development of children at different follow-up points. The total score range of WISC-IV is in percentage (from 0 to 100), where higher scores indicate stronger abilities in the corresponding domains.
  measure: Changes in Child Behavior Checklist (CBCL)
  time frame: 2 years
  description: Conducting follow-up assessments every 3 months using the Child Behavior Checklist (CBCL) scores reflects the emotional and behavioral issues of children at different follow-up points.The scores on the CBCL typically range from 0 to 100, and higher scores may indicate that children are experiencing difficulties in behavior and emotional problems.
  measure: Changes in the Vanderbilt Assessment Scale
  time frame: 2 yaers
  description: The use of the Vanderbilt Assessment Scale scores in follow-up visits every three months reflects the ADHD symptomatology of children at different follow-up milestones. The total score of the Vanderbilt Assessment Scale can range from 0 to 54. A higher score indicates a greater likelihood of ADHD symptoms or difficulties with attention and behavior.
  measure: Changes in Questionnaire-Children with Difficulties.
  time frame: 2 years
  description: Follow-up assessments every 3 months, using the Questionnaire-Children with Difficulties (QCD) scores, reflect children's psychological issues and behavioral difficulties. The scoring range of the QCD questionnaire may vary depending on the specific version or rating system. For example, certain rating systems may categorize scores into levels of severity such as mild, moderate, or severe difficulties. Higher scores may indicate higher levels of psychological difficulties or disorders. Conversely, lower scores may suggest fewer problems or mild manifestations.
  arm group label: Language Disorder
  arm group type: Experimental
  description: The language disorder group had to complete a two-year follow-up and intervention. Collect blood samples from 600 cases of language disorder.
  arm group label: Attention Deficit Hyperactivity Disorder
  arm group type: Experimental
  description: 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.
  arm group label: Normal children
  arm group type: No Intervention
  description: For children aged 1-4, 2 developmental behavioral specialists with associate professor titles or above exclude language barriers.
  arm group label: Healthy children
  arm group type: No Intervention
  description: Children aged 3-6, except ADHD with 2 developmental behavioral and/or psychiatrists with associate professor titles or above.
  intervention type: Other
  intervention name: Functional Training.
  description: 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.
  arm group label: Attention Deficit Hyperactivity Disorder
  arm group label: Language Disorder
  intervention type: Other
  intervention name: Observe.
  description: 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.
  arm group label: Attention Deficit Hyperactivity Disorder
  arm group label: Language Disorder
  criteria: 
  gender: All
  minimum age: 1 Year
  maximum age: 6 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Li Chen, doctor
  role: Study Director
  affiliation: Children's Hospital of Chongqing Medical University
  last name: Li Chen, doctor
  phone: 136 7762 0103
  phone ext: +86
  email: chenli2012@126.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  citation: 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.
  PMID: 23363973
  citation: 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.
  PMID: 34006833
  citation: 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.
  PMID: 33069318
  citation: 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.
  PMID: 28741625
  citation: 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. Erratum In: JAMA Pediatr. 2022 Aug 1;176(8):829.
  PMID: 35666518
  responsible party type: Sponsor-Investigator
  investigator affiliation: Children's Hospital of Chongqing Medical University
  investigator full name: Chen Li
  investigator title: Associate Professor, Director
  mesh term: Language Disorders
  sharing ipd: No
  ipd description: Data is confidential during the study.