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

Not Applicable

Withdrawn

• Conditions: Attention Deficit Hyperactivity Disorder
• Interventions: Behavioral: routine clinical care; Behavioral: Medical-education-community Collaborated Intervention

• Registration Number: NCT04528433
• Lead Sponsor: Children's Hospital of Fudan University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-23
• Study First Submitted QC: 2020-08-23
• Study First Posted: 2020-08-27
• Study Start: 2021-10
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-07
• Last Update Posted: 2022-03-22
• Primary Completion: 2023-10
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
routine clinical care	routine clinical care	-
Medical-education-community Collaborated Intervention	Medical-education-community Collaborated Intervention	-

Primary Outcome Measures

Name	Time	Method
total score change in SNAP-IV scale	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 Outcome Measures

Name	Time	Method
total score change in Behavior Rating Inventory of Executive Function scale	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).