NCT05075447

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 12, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
Last Updated

October 12, 2021

Status Verified

March 1, 2021

Enrollment Period

9 months

First QC Date

July 23, 2021

Last Update Submit

October 9, 2021

Conditions

Keywords

DestructiveCDApathyEmotion regulationTreatment

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • The executive function in real life of 120 children with ADHD

    through the intervention completion, an average of 8 weeks

Study Arms (3)

ADHD group

EXPERIMENTAL

Child diagnosed with ADHD

Behavioral: Emotion Control Treatment Program

control group

NO INTERVENTION

Children without any diagnosis

ADHD+ODD/CD group

EXPERIMENTAL

Child diagnosed with ADHD+ODD/CD

Behavioral: Emotion Control Treatment Program

Interventions

Intervention programs include Child Training and Training in real scenes

ADHD groupADHD+ODD/CD group

Eligibility Criteria

Age4 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xinhua Hospital

Shanghai, 200092, China

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with HyperactivityLethargyEmotional Regulation

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsSelf-ControlSocial BehaviorBehavior

Study Officials

  • Jingyi Wu, Master

    Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2021

First Posted

October 12, 2021

Study Start

March 1, 2021

Primary Completion

December 1, 2021

Study Completion

March 31, 2022

Last Updated

October 12, 2021

Record last verified: 2021-03

Locations