Depressive DisorderNCT06155201
Development and Application of Intelligent Diagnosis and Treatment Norms for Children and Adolescents With Mental Disorders
A study testing functional training and Observation in people with Depressive Disorder and AD, run by Chen Li at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Depressive Disorder, AD, ASD
- What is being tested?
- functional training and Observation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2022to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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;
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Growth,Development and Mental Health of Children and Adolescents Center
Chongqing, Chongqing Municipality, 400014
Li Chen, MD, (+86)13677620103 ext. +86, chenli2012@126.com
About this study
Official title: To Develop Intelligent Warning, Diagnosis and Intervention Systems for Children and Adolescents With Mental Disorders and Developmental Behavioral Disorders
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.
Read the detailed description
- Procedures. From January 2023 to December 2023,obtain the number of primary school students in the nine economic zones of Sichuan and Chongqing, and calculate the proportion of primary school students in each region. Randomly select 2-3 classes from each school's grade (determined based on the proportion of primary school students in each functional region and class size), and use class clusters as the research object. Establish the "Children and Adolescents Mental and Developmental Disabilities Innovation Alliance" in Sichuan and Chongqing areas.From January 2023 to December 2025,finish collecting the required sample size for four types of mental and psychological disorders. Bring into children and adolescents who meet the standards and build the epidemiological database. Develop and continuously improve different intervention plans for Moca and systematic aerobic exercise training in patients with DD, AD, ASD, and ADHD, and apply neuroregulatory techniques to evaluate and treat the aforementioned diseases.During 2025,build intelligent early warning,diagnosis and intervention systems for disease.Finally promote the application of databases and intelligent diagnosis and treatment systems in multiple institutions in more than 10 districts and counties in Sichuan-Chongqing region,with no less than 500 users per unit.
- Demographic questionnaire and clinical data. The demographic questionnaire is completed by the child's primary caregiver, detailing child's name, gender, date of birth, height, weight, blood pressure, heart rate. Clinical data will be ascertained from the medical records, including information about DSM-5 diagnosis, disease classification, current treatment, and comorbid conditions.
- Sample size.This study is an interventional trial. The total number of samples in the database reached>12000. Among them, the total number of depressive disorders reached>5000, the total number of anxiety disorders reached>5000, the total number of autism spectrum disorders reached>1000, and the total number of attention deficit hyperactivity disorder reached>1000. Children with depressive disorders, anxiety disorders, autism spectrum disorders, and attention deficit hyperactivity disorder are required to complete four years of follow-up and intervention. Blood samples will also need to be collected from each child included in the database. Adopt a set of wearable diagnosis and treatment equipment for common mental, psychological and developmental behavioral disorders in children and adolescents, and establish an auxiliary diagnosis and treatment system through brain imaging, brain function imaging, and neuromodulation technology. At the same time, differentiated intervention is carried out in aerobic exercise, quotient theory, and executive skills training, supplemented by the CCBT theory Moca system, structured psychotherapy and artificial intelligence technology, and combined with the auxiliary diagnosis and treatment system to build an intelligent early warning, diagnosis and intervention system.
- Statistical analysis.All the data are analyzed using SPSS 25.0 or R language,which enters by a dedicated person,and checks by three people to ensure accurate data entry.Statistical analysis is completed under the guidance of professional statistical analysts from the Epidemiology Research Office of the project leader's unit.
- Ethical matters and data protection. Before epidemiological survey,children and guardians participating in the study signed a consent form and schools signed a disclaimer.During the study,medical ethics laws and regulations were strictly observed,and psychiatrists,psychologists and pediatricians participated in the entire process to provide health protection for children.And they protect the privacy of subjects and do not disclose subjects' information.
- Conditions
- Depressive Disorder, AD, ASD, ADHD
- Being tested
- functional training, Observation
- Keywords
- intelligence diagnosis and treatment system, Depressive Disorder, AD, ASD, ADHD
- Medical subject headings
- Depressive Disorder, Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
functional trainingBehavioural
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.
ObservationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: functional training; Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2023
- Study start1 Nov 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 12,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chen Li
- Sponsor type
- University, hospital or other
- Collaborators
- Southwest University, China, Sichuan University ，China, First Affiliated Hospital of Chongqing Medical University, Dachuan District People's Hospital，China, Chongqing Beiminglian Digital Technology Co. LTD，China
- Responsible party
- Sponsor-investigator, Chen Li, Children's Hospital of Chongqing Medical University
- Investigators
- Li Chen, doctor, Study director, Children's Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06155201
- Sponsor's protocol ID
- IDTSDA
- Status last verified
- Nov 2023
- First submitted
- 17 Nov 2023
- Last updated
- 4 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data is confidential during the study.
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Develop Intelligent Warning, Diagnosis and Intervention Systems for Children and Adolescents With Mental Disorders and Developmental Behavioral Disorders
- ClinicalTrials.gov ID
- NCT06155201
- Acronym / sponsor ID
- IDTSDA
- Conditions
- Depressive Disorder, AD, ASD, ADHD
- Keywords
- intelligence diagnosis and treatment system, Depressive Disorder, AD, ASD, ADHD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12,000 participants (estimated)
- Lead sponsor
- Chen LiUniversity, hospital or other
- Collaborators
- Southwest University, China, Sichuan University ，China, First Affiliated Hospital of Chongqing Medical University, Dachuan District People's Hospital，China, Chongqing Beiminglian Digital Technology Co. LTD，China
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 4 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- Procedures. From January 2023 to December 2023,obtain the number of primary school students in the nine economic zones of Sichuan and Chongqing, and calculate the proportion of primary school students in each region. Randomly select 2-3 classes from each school's grade (determined based on the proportion of primary school students in each functional region and class size), and use class clusters as the research object. Establish the "Children and Adolescents Mental and Developmental Disabilities Innovation Alliance" in Sichuan and Chongqing areas.From January 2023 to December 2025,finish collecting the required sample size for four types of mental and psychological disorders. Bring into children and adolescents who meet the standards and build the epidemiological database. Develop and continuously improve different intervention plans for Moca and systematic aerobic exercise training in patients with DD, AD, ASD, and ADHD, and apply neuroregulatory techniques to evaluate and treat the aforementioned diseases.During 2025,build intelligent early warning,diagnosis and intervention systems for disease.Finally promote the application of databases and intelligent diagnosis and treatment systems in multiple institutions in more than 10 districts and counties in Sichuan-Chongqing region,with no less than 500 users per unit.
- Demographic questionnaire and clinical data. The demographic questionnaire is completed by the child's primary caregiver, detailing child's name, gender, date of birth, height, weight, blood pressure, heart rate. Clinical data will be ascertained from the medical records, including information about DSM-5 diagnosis, disease classification, current treatment, and comorbid conditions.
- Sample size.This study is an interventional trial. The total number of samples in the database reached>12000. Among them, the total number of depressive disorders reached>5000, the total number of anxiety disorders reached>5000, the total number of autism spectrum disorders reached>1000, and the total number of attention deficit hyperactivity disorder reached>1000. Children with depressive disorders, anxiety disorders, autism spectrum disorders, and attention deficit hyperactivity disorder are required to complete four years of follow-up and intervention. Blood samples will also need to be collected from each child included in the database. Adopt a set of wearable diagnosis and treatment equipment for common mental, psychological and developmental behavioral disorders in children and adolescents, and establish an auxiliary diagnosis and treatment system through brain imaging, brain function imaging, and neuromodulation technology. At the same time, differentiated intervention is carried out in aerobic exercise, quotient theory, and executive skills training, supplemented by the CCBT theory Moca system, structured psychotherapy and artificial intelligence technology, and combined with the auxiliary diagnosis and treatment system to build an intelligent early warning, diagnosis and intervention system.
- Statistical analysis.All the data are analyzed using SPSS 25.0 or R language,which enters by a dedicated person,and checks by three people to ensure accurate data entry.Statistical analysis is completed under the guidance of professional statistical analysts from the Epidemiology Research Office of the project leader's unit.
- Ethical matters and data protection. Before epidemiological survey,children and guardians participating in the study signed a consent form and schools signed a disclaimer.During the study,medical ethics laws and regulations were strictly observed,and psychiatrists,psychologists and pediatricians participated in the entire process to provide health protection for children.And they protect the privacy of subjects and do not disclose subjects' information.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| depression disorder | Experimental | Behavioral: functional training, Other: ObservationThe depressive disorder group must complete four years of follow-up and intervention. Collect blood samples from more than 5,000 patients with depressive disorders. |
| anxiety disorder | Experimental | Behavioral: functional training, Other: ObservationThe anxiety disorder group must complete four years of follow-up and intervention. Collect blood samples from more than 5,000 patients with depressive disorders. |
| autism spectrum disorder | Experimental | Behavioral: functional training, Other: ObservationThe 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. |
| attention deficit hyperactivity disorder | Experimental | Behavioral: functional training, Other: ObservationThe 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. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| functional trainingBased 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. | Behavioural | anxiety disorder, attention deficit hyperactivity disorder, autism spectrum disorder, depression disorder |
| ObservationChildren 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. | Other | anxiety disorder, attention deficit hyperactivity disorder, autism spectrum disorder, depression disorder |
Primary outcome
Changes in the Vanderbilt Assessment Scale
Time frame: 2 years
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.
Changes in the Social Responsive Scale(SRS).
Time frame: 3 years
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.
Changes in the Autism Behavior Scale(ABC).
Time frame: 3 years
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.
Changes in Questionnaire-Children with Difficulties（QCD）
Time frame: 3 years
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.
Changes in the Child Anxiety Related Emotional Disorders Scale（SCARED）.
Time frame: 3 years
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.
Change in the Parenting Stress Index(PSI).
Time frame: 3 years
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.
Change in the Children's Sleep Habits Questionnaire (CSHQ).
Time frame: 3 years
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.
Change in the Epidemiological Studies Depression Scale for Children (CES-DC) .
Time frame: 3 years
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
- Individual participant dataSharing planned: No. Data is confidential during the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li Chen, doctor study director
Children's Hospital of Chongqing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing functional training and Observation in people with Depressive Disorder and AD, run by Chen Li at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li Chen, doctor (13677620103 ext. +86, chenli2012@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the Vanderbilt Assessment Scale (time frame: 2 years). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2023.