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

NCT06025890 | Unknown DMC

• 1 other identifier: CEIDBDBMCS
• Study Type: interventional
• Target: 2,100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

ADHD; Language Disorder; Artificial Intelligence; fNIRS

Outcome Measures

Primary Outcomes (9)

• Changes in the Gesell Developmental Scale(GDS).

  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.

  2 years

• Changes in Infants-Junior High School Students'Social Development Screening Test.

  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.

  2 years

• Changes in Dream-Infant-Toddler Language Communication Screening（DREAM-IT-S）

  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.

  2 years

• Changes in Dreaming Children's Language Standardized Assessment (DREAM-C)

  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.

  2 years

• Changes in Wechsler Preschool and Primary Scale of Intelligence, Fourth Edition (WPPSI-IV) .

  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.

  2 years

• Changes in Wechsler Intelligence Scale for Children, Fourth Edition (WISC-IV).

  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.

  2 years

• Changes in Child Behavior Checklist (CBCL)

  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.

  2 years

• Changes in the Vanderbilt Assessment Scale

  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.

  2 yaers

• Changes in Questionnaire-Children with Difficulties.

  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.

  2 years

Study Arms (4)

Language Disorder

EXPERIMENTAL

The language disorder group had to complete a two-year follow-up and intervention. Collect blood samples from 600 cases of language disorder.

Other: Functional Training.; Other: Observe.

Attention Deficit Hyperactivity Disorder

EXPERIMENTAL

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.

Other: Functional Training.; Other: Observe.

Normal children

NO INTERVENTION

For children aged 1-4, 2 developmental behavioral specialists with associate professor titles or above exclude language barriers.

Healthy children

NO INTERVENTION

Children aged 3-6, except ADHD with 2 developmental behavioral and/or psychiatrists with associate professor titles or above.

Interventions

Functional Training. OTHER

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.

Attention Deficit Hyperactivity Disorder; Language Disorder

Observe. OTHER

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; Language Disorder

Eligibility Criteria

• Age: 1 Year - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• Children with a history of language development delay or language disorder intervention treatment.
• DQ score below 85.
• (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.
• ADHD
• 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.
• 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.
• Children with ADHD intervention treatment.
• DQ score lower than 85, or IQ score lower than 80.
• 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.

Sponsors & Collaborators

• Chen Li: lead
• Southeast University, China: collaborator
• East China Normal University: collaborator
• Shanghai Children's Medical Center: collaborator
• Seventh Medical Center of PLA Army General Hospital: collaborator

Study Sites (1)

Growth, Development and Mental health of Children and Adolescence Center

Chongqing, Chongqing Municipality, 400014, China

RECRUITING

Related Publications (5)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 35666518 BACKGROUND

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Language Disorders

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Li Chen, doctor

  Children's Hospital of Chongqing Medical University

  STUDY DIRECTOR

Central Study Contacts

Li Chen, doctor

CONTACT

136 7762 0103; chenli2012@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, Director

Model Details: 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.

Study Record Dates

• First Submitted: January 31, 2023
• First Posted: September 6, 2023
• Study Start: December 7, 2022
• Primary Completion: June 15, 2025
• Study Completion: December 10, 2025
• Last Updated: September 6, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)