A Randomized Controlled Study of MEFP for Preschool Children With ADHD
Primary Purpose
ADHD, Child, Only
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Metacognitive Executive Function Training
Sponsored by
About this trial
This is an interventional health services research trial for ADHD focused on measuring ADHD, executive function, preschool, intervention
Eligibility Criteria
Inclusion Criteria:
- meet both the criteria of ADHD based on the interview by the DIPA and clinical diagnosis with DSM-5;
- full-scale IQ estimated by the Wechsler Primary and Preschool Scale of Intelligence (WPPSI) above 80;
- their parents volunteered to participate in this study.
Exclusion Criteria:
- child with severe mental disorder or physical disease that might interfere the assessment and intervention, such as Autistic Spectrum Disorder(ASD), schizophrenia, epilepsy, traumatic brain injury, etc.;
- receive medication intervention for their ADHD symptoms before study;
- parents with severe mental illness, such as schizophrenia, mood disorder (period of onset), etc..
Sites / Locations
- Xinhua Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group
Waiting group
Arm Description
Subjects in this group will receive the "Metacognitive Executive Function Training (MEFP)" program in aiming to reduce ADHD symptoms and improve the executive function.
Subjects in this group will not receive the MEFP program during the study period.
Outcomes
Primary Outcome Measures
The executive function of preschool child of ADHD
The executive function of preschool children of ADHD assessed by neuropsychological evaluation tool NEPSY
Secondary Outcome Measures
The executive function in real life of preschool child of ADHD
The executive function in real life of preschool children of ADHD assessed by BRIEF
The ADHD symptoms of child
The ADHD symptoms of child assessed by SNAP
Full Information
NCT ID
NCT03515135
First Posted
November 7, 2017
Last Updated
March 16, 2020
Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT03515135
Brief Title
A Randomized Controlled Study of MEFP for Preschool Children With ADHD
Official Title
Metacognitive Executive Function Training for Preschool Children With ADHD - A Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
December 30, 2018 (Actual)
Study Completion Date
December 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The goal of this study is to provide a new, early treatment approach for preschoolers with ADHD, which could facilitate the EF developing well to achieve better outcome.
Detailed Description
ADHD in preschoolers has become established as a valid psychiatric disorder with characterized core deficits of executive function (EF). The EF impairments occurred in preschool period could persist to childhood, adolescent and adulthood, causing extensive and deep damage of individual's academic and career achievement, social function, and peer relationship. Psychostimulants remain a controversial opinion for preschoolers and appear less efficacious and more common side effects. It is very important to explore the effective nonpharmacological intervention targeting the EF deficits and appropriately tailored to young children. Therefore, the investigators conduct this randomized and controlled study to find out the therapeutic efficacy of metacognitive Executive Function Training for Preschool Children with ADHD (MEFP), and follow the subjects to observe whether the therapeutic efficacy would persist. In the mean time, the investigators also observe the factors which can influence the therapeutic efficacy. The goal of this study is to provide a new, early treatment approach for preschoolers with ADHD, which could facilitate the EF developing well to achieve better outcome.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD, Child, Only
Keywords
ADHD, executive function, preschool, intervention
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
96 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Subjects in this group will receive the "Metacognitive Executive Function Training (MEFP)" program in aiming to reduce ADHD symptoms and improve the executive function.
Arm Title
Waiting group
Arm Type
No Intervention
Arm Description
Subjects in this group will not receive the MEFP program during the study period.
Intervention Type
Behavioral
Intervention Name(s)
Metacognitive Executive Function Training
Intervention Description
Training the executive funtions of preshcool ADHD children through tasks and games repeatly but with fun. Giving the parents strategies to help the prechool ADHD childred coping the symptoms and develop EF in the reallife.
Primary Outcome Measure Information:
Title
The executive function of preschool child of ADHD
Description
The executive function of preschool children of ADHD assessed by neuropsychological evaluation tool NEPSY
Time Frame
through the intervention completion, an average of 8 weeks
Secondary Outcome Measure Information:
Title
The executive function in real life of preschool child of ADHD
Description
The executive function in real life of preschool children of ADHD assessed by BRIEF
Time Frame
through the intervention completion, an average of 8 weeks
Title
The ADHD symptoms of child
Description
The ADHD symptoms of child assessed by SNAP
Time Frame
through the intervention completion, an average of 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
meet both the criteria of ADHD based on the interview by the DIPA and clinical diagnosis with DSM-5;
full-scale IQ estimated by the Wechsler Primary and Preschool Scale of Intelligence (WPPSI) above 80;
their parents volunteered to participate in this study.
Exclusion Criteria:
child with severe mental disorder or physical disease that might interfere the assessment and intervention, such as Autistic Spectrum Disorder(ASD), schizophrenia, epilepsy, traumatic brain injury, etc.;
receive medication intervention for their ADHD symptoms before study;
parents with severe mental illness, such as schizophrenia, mood disorder (period of onset), etc..
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lan Shuai, Ph.D
Organizational Affiliation
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xinhua Hospital
City
Shanghai
ZIP/Postal Code
200092
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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A Randomized Controlled Study of MEFP for Preschool Children With ADHD
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