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

Overview

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.

Full Title of Study: “A Randomized Controlled Study of Medical-education-community Collaborated Intervention in Children With Attention Deficit Hyperactivity Disorder”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Investigator, Outcomes Assessor)
  • Study Primary Completion Date: October 2023

Interventions

  • 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.
  • 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.

Arms, Groups and Cohorts

  • Experimental: Medical-education-community Collaborated Intervention
  • Active Comparator: routine clinical care

Clinical Trial Outcome Measures

Primary Measures

  • total score change in SNAP-IV scale
    • Time Frame: Baseline, 3 months after enrollment
    • 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).

Secondary Measures

  • total score change in Behavior Rating Inventory of Executive Function scale
    • Time Frame: Baseline, 3 months after enrollment
    • 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).

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 7 Years

Maximum Age: 12 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Children’s Hospital of Fudan University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Mengyao Li, PhD, Study Chair, Department of Psychological Medicine, Children’s Hospital of Fudan University

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