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

A Randomized Controlled Study of Medical-education-community Collaborated Intervention in Children With Attention Deficit Hyperactivity Disorder

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.

Study Overview

• Status: Withdrawn
• Conditions: Attention Deficit Hyperactivity Disorder
• Intervention / Treatment: Behavioral: Medical-education-community Collaborated Intervention; Behavioral: routine clinical care

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Medical-education-community Collaborated Intervention	Behavioral: 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.
Active Comparator: routine clinical care	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
total score change in SNAP-IV scale	It is a repeated measurement. The Swanson, Nolan, and Pelham Questionnaire (SNAP-IV) Rating Scale is a revised version of the Swanson, Nolan and Pelham (SNAP) Questionnaire that utilizes the DSM-IV criteria for ADHD and oppositional defiant disorder, rated by caregiver or professionals. It comprises three subscales: Inattention, Hyperactivity/Impulsivity, and Oppositional Defiant Disorder. The score of each item is rated with a 4-point Likert scale (0 = not at all, 3 = very much). We choose the total score ofInattention and Hyperactivity/Impulsivityfor the evaluation of change in ADHD symptom in children. The score is calculated by adding all the items inthe two subscales. The change of score is calculated by score at 3 months enrollment minus score at baseline (enrollment).	Baseline, 3 months after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
total score change in Behavior Rating Inventory of Executive Function scale	It is a repeated measurement. The Behavior Rating Inventory of Executive Function(BRIEF) Scale reflects the performance of children's deficits in executive function in daily life, which covers a number of organizational skills involved in organizational skills training. We choose the total score ofBRIEF for the evaluation of change in organizational skills in children. The score is calculated by the published recording chart. The change of score is calculated by score at 3 months enrollment minus score at baseline (enrollment).	Baseline, 3 months after enrollment

Collaborators and Investigators

• Sponsor: Children's Hospital of Fudan University
• Investigators: Study Chair: Mengyao Li, PhD, Department of Psychological Medicine, Children's Hospital of Fudan University

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2021
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: August 23, 2020
• First Submitted That Met QC Criteria: August 23, 2020
• First Posted (Actual): August 27, 2020

Study Record Updates

• Last Update Posted (Actual): March 22, 2022
• Last Update Submitted That Met QC Criteria: March 7, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity; Hyperkinesis
• Other Study ID Numbers: xlklmy01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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