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

NCT04528433 | Withdrawn

• 1 other identifier: xlklmy01
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• total score change in Behavior Rating Inventory of Executive Function scale

  Baseline, 3 months after enrollment

Study Arms (2)

Medical-education-community Collaborated Intervention

EXPERIMENTAL

Behavioral: Medical-education-community Collaborated Intervention

routine clinical care

ACTIVE COMPARATOR

Behavioral: routine clinical care

Interventions

Medical-education-community Collaborated Intervention BEHAVIORAL

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.

Medical-education-community Collaborated Intervention

routine clinical care BEHAVIORAL

Routine clinical care includes a structured family behavioral intervention for ADHD symptom management and organizational skill training, the medication will be used if necessary.

routine clinical care

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Diagnosed with ADHD
• Doctor rated SNAP-IV Inattention of Hyperactivity/Impulsivity score\>12
• Full-Scale Intelligence Quotient\>=80 (Wechsler intelligence scale for children-IV)

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Mengyao Li, PhD

  Department of Psychological Medicine, Children's Hospital of Fudan University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 23, 2020
• First Posted: August 27, 2020
• Study Start: October 1, 2021
• Primary Completion: October 1, 2023
• Study Completion: December 1, 2023
• Last Updated: March 22, 2022

Record last verified: 2022-03