A Randomized Controlled Study of Medical-education-community Collaborated Intervention in Children With ADHD

NCT ID: NCT04528433

Last Updated: 2022-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-31

Study Completion Date

2023-12-31

Brief Summary

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This study is designed to test if the medical-education-community collaborated intervention can reduce the symptoms of children with Attention deficit hyperactivity disorder (ADHD) compared to routine clinical care. Investigators will also evaluate if the intervention will positively affect organizational skills and academic achievement compared to controls.

Detailed Description

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Conditions

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Attention Deficit Hyperactivity Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The present study will be carried out using a parallel randomized study design. Each participant will be randomly assigned either to the collaborated intervention or to the routine clinical care control group.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
The medical treatment of participants will be given by a doctor who does not know the study group of the patient. The investigator of the primary outcome and secondary outcome will also be unaware of the grouping of the patient. One psychiatrist blind of grouping will ask parents about the ADHD symptom of their children and rate it with SNAP-IV score.

Study Groups

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Medical-education-community Collaborated Intervention

Group Type EXPERIMENTAL

Medical-education-community Collaborated Intervention

Intervention Type BEHAVIORAL

The Medical-education-community Collaborated Intervention adds an additional part in comparison with the control group of classroom management guidance for teachers, review and practice organizational skills based on school daily activities in the school, teacher rewards and encouragement of students.

routine clinical care

Group Type ACTIVE_COMPARATOR

routine clinical care

Intervention Type BEHAVIORAL

Routine clinical care includes a structured family behavioral intervention for ADHD symptom management and organizational skill training, the medication will be used if necessary.

Interventions

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Medical-education-community Collaborated Intervention

The Medical-education-community Collaborated Intervention adds an additional part in comparison with the control group of classroom management guidance for teachers, review and practice organizational skills based on school daily activities in the school, teacher rewards and encouragement of students.

Intervention Type BEHAVIORAL

routine clinical care

Routine clinical care includes a structured family behavioral intervention for ADHD symptom management and organizational skill training, the medication will be used if necessary.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with ADHD
* Doctor rated SNAP-IV Inattention of Hyperactivity/Impulsivity score\>12
* Full-Scale Intelligence Quotient\>=80 (Wechsler intelligence scale for children-IV)

Exclusion Criteria

* Accepting any type of psychological treatment during the intervention
* Comorbid with epileptic disorder or other existing physical disorder, Tourette syndrome, Autism Spectrum Disorder, learning disorder, mood disorder, psychiatric disorder, or under suicidal risk
* Attending any other clinical research at the same time
Minimum Eligible Age

7 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital of Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mengyao Li, PhD

Role: STUDY_CHAIR

Department of Psychological Medicine, Children's Hospital of Fudan University

Other Identifiers

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xlklmy01

Identifier Type: -

Identifier Source: org_study_id

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