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Clinical Trials/NCT04528433
NCT04528433
Withdrawn
Not Applicable

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

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Attention Deficit Hyperactivity Disorder
Sponsor
Children's Hospital of Fudan University
Primary Endpoint
total score change in SNAP-IV scale
Status
Withdrawn
Last Updated
4 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
October 2021
End Date
December 2023
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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 Outcomes

  • total score change in Behavior Rating Inventory of Executive Function scale(Baseline, 3 months after enrollment)

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