Lack of; Attention, With Hyperactivity (ADHD)NCT05075447
Treatment Plan for ADHD With Indifferent Traits
A study of Lack of; Attention, With Hyperactivity (ADHD), run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
For children with ADHD aged 4-10 at the time of enrollment, starting from preschool, focusing on apathy and emotional control, using psycho-behavioral measurements, EEG experiments, and eye tracking technology to evaluate and implement targeted Sexual intervention and six-month follow-up. Read more about this study
- Who is it for?
- Ages 4 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Lack of; Attention, With Hyperactivity (ADHD)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2021to 31 Mar 2022
- 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 4 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 4 years, 0 months and 10 years old and 11 months old, who have been diagnosed by a doctor who is at least the attending physician in the pediatric psychiatric department and meet the American Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) ADHD diagnostic criteria, have a total IQ higher than 80, and the subjects are doing this The baseline level of the study has not received any medical treatment before.
Who cannot join
- Attention deficit disorder caused by organic diseases of the nervous system, extensive developmental disorders, mental retardation, childhood schizophrenia, mood disorders, epilepsy, and other organic diseases or other primary mental disorders; exclude parents or guardians from suffering Severe mental illness, such as schizophrenia, mood disorders (onset period), etc., and a degree below junior high school.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xinhua Hospital
Shanghai, 200092
Lan Shuai, Ph.D
About this study
Official title: Diagnosis and Treatment Plan for Destructive and Conduct Disorder Children With Indifferent Traits and Emotion Regulation
For children with ADHD aged 4-10 at the time of enrollment, starting from preschool, focusing on apathy and emotional control, using psycho-behavioral measurements, EEG experiments, and eye tracking technology to evaluate and implement targeted Sexual intervention and six-month follow-up. Establish a diagnosis and treatment decision analysis model and psychological treatment plan for ODD/CD.
Read the detailed description
Destructive, conduct disorder children have emotional processing defects, including apathy and ruthless traits, emotional disorders, may be early diagnosis of conduct disorder (Conduct Disorder, CD) or attention deficit hyperactivity disorder (Attention Deficit Hyperactivity Disorders, ADHD) comorbid CD sensitivity Sexual indicators, systemic psychotherapy for these children's indifference characteristics and emotional disorders will improve related symptoms. This study will start with preschool children with ADHD, design evaluation indicators for emotional traits for children aged 4-10, combined with various psychological evaluations, and use advanced brain electricity combined with eye tracking research technology to provide candidate indicators for evaluation; and On the basis of previous research, establish a treatment plan to improve pathological emotional characteristics and emotional disorders; establish a predictive intervention decision model from preschool to school-age ADHD comorbid CD to provide methods for precise diagnosis and treatment options. The early prevention and intervention of ADHD and CD has practical significance and maneuverability.
- Being tested
- Emotion Control Treatment Program
- Keywords
- Destructive, CD, Apathy, Emotion regulation, Treatment
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Lethargy, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotion Control Treatment ProgramBehavioural
Intervention programs include Child Training and Training in real scenes
| Study group | Role | What they receive |
|---|---|---|
| ADHD group | Experimental | Child diagnosed with ADHD Receives: Behavioral: Emotion Control Treatment Program |
| control group | No intervention | Children without any diagnosis |
| ADHD+ODD/CD group | Experimental | Child diagnosed with ADHD+ODD/CD Receives: Behavioral: Emotion Control Treatment Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apathy and ruthlessness（CU traits） of 60 children with ADHD
The CU traits of children with ADHD assessed by A CU questionnaire tests.
Measured: Collected when the case is enrolled
Apathy and ruthlessness（CU traits） of 60 children with ADHD+ODD/CD
The CU traits of children with ADHD assessed by A CU questionnaire tests.
Measured: Collected when the case is enrolled
Secondary outcomes (1)
The executive function in real life of 120 children with ADHD
The executive function in real life of 120 children with ADHD assessed by BRIEF
Measured: through the intervention completion, an average of 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2021
- Study start1 Mar 2021
- Primary completion1 Dec 2021 (estimated)
- Study completion31 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lack of; Attention, With Hyperactivity (ADHD)Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jingyi Wu, Master, Principal investigator, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05075447
- Sponsor's protocol ID
- XH-21-007
- Status last verified
- Mar 2021
- First submitted
- 23 Jul 2021
- Last updated
- 12 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis and Treatment Plan for Destructive and Conduct Disorder Children With Indifferent Traits and Emotion Regulation
- ClinicalTrials.gov ID
- NCT05075447
- Acronym / sponsor ID
- XH-21-007
- Keywords
- Destructive, CD, Apathy, Emotion regulation, Treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 12 Oct 2021 (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.
For children with ADHD aged 4-10 at the time of enrollment, starting from preschool, focusing on apathy and emotional control, using psycho-behavioral measurements, EEG experiments, and eye tracking technology to evaluate and implement targeted Sexual intervention and six-month follow-up. Establish a diagnosis and treatment decision analysis model and psychological treatment plan for ODD/CD.
Detailed description
Destructive, conduct disorder children have emotional processing defects, including apathy and ruthless traits, emotional disorders, may be early diagnosis of conduct disorder (Conduct Disorder, CD) or attention deficit hyperactivity disorder (Attention Deficit Hyperactivity Disorders, ADHD) comorbid CD sensitivity Sexual indicators, systemic psychotherapy for these children's indifference characteristics and emotional disorders will improve related symptoms. This study will start with preschool children with ADHD, design evaluation indicators for emotional traits for children aged 4-10, combined with various psychological evaluations, and use advanced brain electricity combined with eye tracking research technology to provide candidate indicators for evaluation; and On the basis of previous research, establish a treatment plan to improve pathological emotional characteristics and emotional disorders; establish a predictive intervention decision model from preschool to school-age ADHD comorbid CD to provide methods for precise diagnosis and treatment options. The early prevention and intervention of ADHD and CD has practical significance and maneuverability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ADHD group | Experimental | Behavioral: Emotion Control Treatment ProgramChild diagnosed with ADHD |
| control group | No intervention | –Children without any diagnosis |
| ADHD+ODD/CD group | Experimental | Behavioral: Emotion Control Treatment ProgramChild diagnosed with ADHD+ODD/CD |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children aged 4 years, 0 months and 10 years old and 11 months old, who have been diagnosed by a doctor who is at least the attending physician in the pediatric psychiatric department and meet the American Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) ADHD diagnostic criteria, have a total IQ higher than 80, and the subjects are doing this The baseline level of the study has not received any medical treatment before.
Key exclusion criteria (1 listed)
- Attention deficit disorder caused by organic diseases of the nervous system, extensive developmental disorders, mental retardation, childhood schizophrenia, mood disorders, epilepsy, and other organic diseases or other primary mental disorders; exclude parents or guardians from suffering Severe mental illness, such as schizophrenia, mood disorders (onset period), etc., and a degree below junior high school.
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 |
|---|---|---|
| Emotion Control Treatment ProgramIntervention programs include Child Training and Training in real scenes | Behavioural | ADHD group, ADHD+ODD/CD group |
Primary outcome
Apathy and ruthlessness（CU traits） of 60 children with ADHD
Time frame: Collected when the case is enrolled
The CU traits of children with ADHD assessed by A CU questionnaire tests.
Apathy and ruthlessness（CU traits） of 60 children with ADHD+ODD/CD
Time frame: Collected when the case is enrolled
The CU traits of children with ADHD assessed by A CU questionnaire tests.
1 secondary outcome
The executive function in real life of 120 children with ADHD
Time frame: through the intervention completion, an average of 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2021.
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.
Jingyi Wu, Master principal investigator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Lack of; Attention, With Hyperactivity (ADHD), run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine 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 1 inclusion and 1 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 12 Oct 2021. 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 Jingyi Wu, Master (008618616014207, mmmigrant@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apathy and ruthlessness（CU traits） of 60 children with ADHD (time frame: Collected when the case is enrolled). The study lists 2 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 12 Oct 2021.