Back to resultsA Randomized Controlled Study of Medical-education-community Collaborated Intervention in Children With ADHD
Primary Purpose
Attention Deficit Hyperactivity Disorder
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Medical-education-community Collaborated Intervention
routine clinical care
Sponsored by
About this trial
This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Medical-education-community Collaborated Intervention
routine clinical care
Arm Description
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
Full Information
NCT ID
NCT04528433
First Posted
August 23, 2020
Last Updated
March 7, 2022
Sponsor
Children's Hospital of Fudan University
1. Study Identification
Unique Protocol Identification Number
NCT04528433
Brief Title
A Randomized Controlled Study of Medical-education-community Collaborated Intervention in Children With ADHD
Official Title
A Randomized Controlled Study of Medical-education-community Collaborated Intervention in Children With Attention Deficit Hyperactivity Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Withdrawn
Why Stopped
lack of funding
Study Start Date
October 2021 (Anticipated)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Fudan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
InvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Medical-education-community Collaborated Intervention
Arm Type
Experimental
Arm Title
routine clinical care
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Medical-education-community Collaborated Intervention
Intervention Description
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
Intervention Name(s)
routine clinical care
Intervention Description
Routine clinical care includes a structured family behavioral intervention for ADHD symptom management and organizational skill training, the medication will be used if necessary.
Primary Outcome Measure Information:
Title
total score change in SNAP-IV scale
Description
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).
Time Frame
Baseline, 3 months after enrollment
Secondary Outcome Measure Information:
Title
total score change in Behavior Rating Inventory of Executive Function scale
Description
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).
Time Frame
Baseline, 3 months after enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mengyao Li, PhD
Organizational Affiliation
Department of Psychological Medicine, Children's Hospital of Fudan University
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Randomized Controlled Study of Medical-education-community Collaborated Intervention in Children With ADHD
We'll reach out to this number within 24 hrs