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Treatment Plan for ADHD With Indifferent Traits

Primary Purpose

Lack of; Attention, With Hyperactivity (ADHD)

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Emotion Control Treatment Program
Sponsored by
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lack of; Attention, With Hyperactivity (ADHD) focused on measuring Destructive, CD, Apathy, Emotion regulation, Treatment

Eligibility Criteria

4 Years - 10 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Xinhua HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Experimental

Arm Label

ADHD group

control group

ADHD+ODD/CD group

Arm Description

Child diagnosed with ADHD

Children without any diagnosis

Child diagnosed with ADHD+ODD/CD

Outcomes

Primary Outcome Measures

Apathy and ruthlessness(CU traits) of 60 children with ADHD
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
The CU traits of children with ADHD assessed by A CU questionnaire tests.

Secondary Outcome Measures

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

Full Information

First Posted
July 23, 2021
Last Updated
October 9, 2021
Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05075447
Brief Title
Treatment Plan for ADHD With Indifferent Traits
Official Title
Diagnosis and Treatment Plan for Destructive and Conduct Disorder Children With Indifferent Traits and Emotion Regulation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
December 1, 2021 (Anticipated)
Study Completion Date
March 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lack of; Attention, With Hyperactivity (ADHD)
Keywords
Destructive, CD, Apathy, Emotion regulation, Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ADHD group
Arm Type
Experimental
Arm Description
Child diagnosed with ADHD
Arm Title
control group
Arm Type
No Intervention
Arm Description
Children without any diagnosis
Arm Title
ADHD+ODD/CD group
Arm Type
Experimental
Arm Description
Child diagnosed with ADHD+ODD/CD
Intervention Type
Behavioral
Intervention Name(s)
Emotion Control Treatment Program
Intervention Description
Intervention programs include Child Training and Training in real scenes
Primary Outcome Measure Information:
Title
Apathy and ruthlessness(CU traits) of 60 children with ADHD
Description
The CU traits of children with ADHD assessed by A CU questionnaire tests.
Time Frame
Collected when the case is enrolled
Title
Apathy and ruthlessness(CU traits) of 60 children with ADHD+ODD/CD
Description
The CU traits of children with ADHD assessed by A CU questionnaire tests.
Time Frame
Collected when the case is enrolled
Secondary Outcome Measure Information:
Title
The executive function in real life of 120 children with ADHD
Description
The executive function in real life of 120 children with ADHD assessed by BRIEF
Time Frame
through the intervention completion, an average of 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jingyi Wu, Master
Phone
008618616014207
Email
mmmigrant@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jingsong Zhang, Ph.D
Phone
+86-021-25076680
Email
zhangjinsong@xinhuamed.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jingyi Wu, Master
Organizational Affiliation
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xinhua Hospital
City
Shanghai
ZIP/Postal Code
200092
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lan Shuai, Ph.D

12. IPD Sharing Statement

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Treatment Plan for ADHD With Indifferent Traits

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