Treatment Plan for ADHD With Indifferent Traits

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.

Study Overview

• Status: Recruiting
• Conditions: Lack of; Attention, With Hyperactivity (ADHD)
• Intervention / Treatment: Behavioral: Emotion Control Treatment Program

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 Type: Interventional
• Enrollment (Anticipated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jingyi Wu, Master; Phone Number: 008618616014207; Email: mmmigrant@163.com
• Study Contact Backup: Name: Jingsong Zhang, Ph.D; Phone Number: +86-021-25076680; Email: zhangjinsong@xinhuamed.com.cn

Study Locations

• China
  • Shanghai, China, 200092
    • Recruiting
    • Xinhua hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 10 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ADHD group; Child diagnosed with ADHD	Behavioral: Emotion Control Treatment Program; Intervention programs include Child Training and Training in real scenes
No Intervention: control group; Children without any diagnosis
Experimental: ADHD+ODD/CD group; Child diagnosed with ADHD+ODD/CD	Behavioral: Emotion Control Treatment Program; Intervention programs include Child Training and Training in real scenes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Apathy and ruthlessness（CU traits） of 60 children with ADHD	The CU traits of children with ADHD assessed by A CU questionnaire tests.	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.	Collected when the case is enrolled

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	through the intervention completion, an average of 8 weeks

Collaborators and Investigators

• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Investigators: Principal Investigator: Jingyi Wu, Master, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): March 31, 2022

Study Registration Dates

• First Submitted: July 23, 2021
• First Submitted That Met QC Criteria: October 9, 2021
• First Posted (Actual): October 12, 2021

Study Record Updates

• Last Update Posted (Actual): October 12, 2021
• Last Update Submitted That Met QC Criteria: October 9, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Treatment; CD; Emotion regulation; Apathy; Destructive
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Hyperkinesis
• Other Study ID Numbers: XH-21-007

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No