Development and Application of Intelligent Diagnosis and Treatment Norms for Children and Adolescents With Mental Disorders

NCT06155201 | Unknown

• 1 other identifier: IDTSDA
• Study Type: interventional
• Target: 12,000
• Locations: 1 country
• Sites: 1

Brief Summary

The prevalence of mental disorders and developmental behavioral disorders (such as depressive disorders,anxiety disorders, autism spectrum disorders,attention deficit disorder,ect.)among children and adolescents in China is increasing,leading to difficulty in early identification of children and poor diagnosis and treatment effects,which brings significant financial burden to the families and the country.We will carry out a multi-center epidemiological survey on common mental disorders above among children and adolescents in Sichuan-Chongqing region and clarify the prevalence,geographical distribution and demographic characteristics.A total of more than 12,000 children and adolescents under 18 years old with a diagnosis of depression/anxiety disorders/ASD/ADHD based on DSM-5 criteria is included to build a research platform and database,so that we will formulate intelligence diagnosis and treatment standards.This study will establish the "Children and Adolescents Mental and Developmental Disabilities Innovation Alliance" in Sichuan and Chongqing areas and finally build intelligent early warning,diagnosis and intervention systems for disease in hope that technology transformation to be promoted and applied.

Conditions

Depressive Disorder; AD; ASD; ADHD

Keywords

intelligence diagnosis and treatment system; Depressive Disorder; AD; ASD; ADHD

Outcome Measures

Primary Outcomes (8)

• 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 years

• Changes in the Social Responsive Scale(SRS).

  Children are followed up every 3 months, and at each follow-up point, the SRS is used to assess a child's level of social sensitivity and interpersonal skills. The SRS score ranges from 0 to 68, where 0 to 15 is considered low risk, 16 to 30 is considered medium risk, and 31 to 68 is considered high risk.

  3 years

• Changes in the Autism Behavior Scale(ABC).

  Conducting follow-up assessments every 3 months using the Autism Behavior Scale (ABC) scores reflect five dimensions, including sensation, communication, body movement, language and self-care. The total score ranges from 0 to 158. Higher scores may indicate that the child has more severe symptoms of developmental disorders such as autism.

  3 years

• Changes in Questionnaire-Children with Difficulties（QCD）

  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.

  3 years

• Changes in the Child Anxiety Related Emotional Disorders Scale（SCARED）.

  Conducting follow-up assessments every 3 months using the Child Anxiety Related Emotional Disorders Scale（SCARED）scores reflect children's anxiety symptoms mainly from five dimensions: somatization/panic, generalized anxiety, dissociative anxiety, social phobia, and school phobia of children at different follow-up points. Score 0-3 ("not at all" is 0, "sometimes" is 1, and "very often" is 2). Scores greater than or equal to 23 indicate the possibility of anxiety.The higher the score, the higher the level of anxiety.

  3 years

• Change in the Parenting Stress Index(PSI).

  Conducting follow-up assessments every 3 months using the Parenting Stress Index (PSI) ,which is a popular brief assessment of parenting stress. The higher score indicates more anxious the parents are.

  3 years

• Change in the Children's Sleep Habits Questionnaire (CSHQ).

  Conducting follow-up assessments every 3 months using the Children's Sleep Habits Questionnaire (CSHQ) score reflects key sleep domains that encompass the major medical and behavioral sleep disorders. It's a useful sleep screening instrument to identify both behaviorally based and medically-based sleep problems in school-aged children, which could get the children's sleep time, total score of sleep quality and scores of eight dimensions. A total score higher than 54 points indicates poor sleep quality.

  3 years

• Change in the Epidemiological Studies Depression Scale for Children (CES-DC) .

  CES-DC is specially designed to evaluate the frequency of current depressive symptoms in children. It focuses on depressive affect or mood, reflecting the depressive mood, guilt and worthlessness, helplessness and hopelessness, and psychomotor retardation of the depressive state. , loss of appetite, sleep disorders.

  3 years

Study Arms (4)

depression disorder

EXPERIMENTAL

The depressive disorder group must complete four years of follow-up and intervention. Collect blood samples from more than 5,000 patients with depressive disorders.

Behavioral: functional training; Other: Observation

anxiety disorder

EXPERIMENTAL

The anxiety disorder group must complete four years of follow-up and intervention. Collect blood samples from more than 5,000 patients with depressive disorders.

Behavioral: functional training; Other: Observation

autism spectrum disorder

EXPERIMENTAL

The autism spectrum disorder group must complete four years of follow-up and intervention. Collect blood samples from more than 1,000 patients with depressive disorders.

Behavioral: functional training; Other: Observation

attention deficit hyperactivity disorder

EXPERIMENTAL

The attention deficit hyperactivity disorder group must complete four years of follow-up and intervention. Collect blood samples from more than 1,000 patients with depressive disorders.

Behavioral: functional training; Other: Observation

Interventions

functional training BEHAVIORAL

Based on individual differences, children are provided with structural psychological behavioral therapy, including the implementation of aerobic exercise and executive skills training based on motivational quotient theory. Use brain imaging, brain functional imaging and neuromodulation technology to improve children's symptoms.

anxiety disorder; attention deficit hyperactivity disorder; autism spectrum disorder; depression disorder

Observation OTHER

Children with depressive disorders, anxiety disorders, autism spectrum disorders, and attention deficit hyperactivity disorder were recruited at presentation. Differential interventions and assessments were conducted during the study.

anxiety disorder; attention deficit hyperactivity disorder; autism spectrum disorder; depression disorder

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Depression patients:(1)Diagnose of depression according to DSM-5;Having the ability to act independently;Clear awareness;Able to communicate normally;Consent to the study ; (2)Under 18 years old;
• Anxiety patients: (1)Diagnose of anxiety according to DSM-5;Having the ability to act independently;Clear awareness;Able to communicate normally;Consent to the study ; (2)Under 18 years old;
• ASD patients:(1) Diagnose of ASD according to DSM-5;Do not have other neurological developmental disorders; (2)Under 18 years old;
• ADHD patients: (1) Diagnose of ADHD according to DSM-5;Do not have other neurological developmental disorders; (2)Aged 4-18 years old;

You may not qualify if:

• suffering other mental illnesses and neurological disorders now or in the past
• suffering severe physical illnesses now or in the past
• substance or drug abuse now or in the past

Sponsors & Collaborators

• Chen Li: lead
• Southwest University, China: collaborator
• Sichuan University ，China: collaborator
• First Affiliated Hospital of Chongqing Medical University: collaborator
• Dachuan District People's Hospital，China: collaborator
• Chongqing Beiminglian Digital Technology Co. LTD，China: collaborator

Study Sites (1)

Growth,Development and Mental Health of Children and Adolescents Center

Chongqing, Chongqing Municipality, 400014, China

RECRUITING

MeSH Terms

Conditions

Depressive Disorder; Attention Deficit Disorder with Hyperactivity

Interventions

Observation

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Li Chen, doctor

  Children's Hospital of Chongqing Medical University

  STUDY DIRECTOR

Central Study Contacts

Li Chen, doctor

CONTACT

13677620103; 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 more than 5,000 patients with depression, more than 5,000 patients with anxiety disorders, more than1000 patients with autism spectrum disorder, and more than1000 patients with attention deficit hyperactivity disorder, and complete different intervention for a total of more than 12,000 patients. Based on the CCBT theory Moca system and systematic aerobic exercise system and other projects, personalized functional training intervention for children can be achieved. Use wearable diagnostic and treatment equipment, such as brain imaging, brain functional imaging, and neuromodulation technology to assist diagnosis and treatment; use structured psychological behavioral therapy and artificial intelligence technology to improve management.

Study Record Dates

• First Submitted: November 17, 2023
• First Posted: December 4, 2023
• Study Start: November 1, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: December 4, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)