A Randomized Controlled Study of Family Based EF Training for Schoolage Children With ADHD
Primary Purpose
ADHD, Child, Only
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Family based Executive Function Training
Sponsored by
About this trial
This is an interventional health services research trial for ADHD focused on measuring ADHD, executive function, schoolage, family-based intervention
Eligibility Criteria
Inclusion Criteria:
- meet both the criteria of ADHD based on the interview by the CDIS and clinical diagnosis with DSM-5;
- full-scale IQ estimated bythe Wechsler Intelligence Scale for Children-Revised Form (WISC-R) 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.;
- 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 "Famliy based Executive Function Training " program in aiming to reduce ADHD symptoms and improve the executive function.
Subjects in this group will not receive the "Famliy based Executive Function Training " program during the study period.
Outcomes
Primary Outcome Measures
The executive function of of schoolage child of ADHD
The core symptoms of schoolage children of ADHD assessed by neuropsychological evaluation tool NEPSY
Secondary Outcome Measures
The executive function in real life of schoolage child of ADHD
The executive function in real life of schoolage children of ADHD assessed by BRIEF
The ADHD symptoms of child
The ADHD symptoms of child assessed by SNAP
Full Information
NCT ID
NCT05025501
First Posted
August 25, 2021
Last Updated
August 25, 2021
Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT05025501
Brief Title
A Randomized Controlled Study of Family Based EF Training for Schoolage Children With ADHD
Official Title
Family Based Executive Function Training for Schoolage Children With ADHD - A Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
February 6, 2022 (Anticipated)
Study Completion Date
February 6, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
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
5. Study Description
Brief Summary
The goal of this study is to provide a new treatment approach for schoolage children 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. Although medication showed significant effectiveness in controlling the core symptoms of ADHD, it failed to help patients master compensatory strategies to cope with functional impairments in learning and life events. The family intervention program for school-age ADHD children is still rare, and it is a blank field in China. At present, most of these related studies have not integrated task training in realistic scenarios with parent training, and lack of randomized and controlled Settings, which makes the effect of intervention less convincing. Therefore, the investigators conduct this randomized and controlled study to find out the therapeutic efficacy of Family-based Executive Function Training for Schoolage Children with ADHD, 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 treatment approach for schoolage children 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, schoolage, family-based intervention
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Subjects in this group will receive the "Famliy based Executive Function Training " 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 "Famliy based Executive Function Training " program during the study period.
Intervention Type
Behavioral
Intervention Name(s)
Family based Executive Function Training
Intervention Description
Training the executive funtions of shcoolage ADHD children through tasks and games repeatly but with fun. Giving the parental training and support for the parenting role parents strategies to help the shcoolage ADHD childred coping the symptoms and develop EF in the reallife and improve parent-child relationship.
Primary Outcome Measure Information:
Title
The executive function of of schoolage child of ADHD
Description
The core symptoms of schoolage children of ADHD assessed by neuropsychological evaluation tool NEPSY
Time Frame
through the intervention completion, an average of 12 weeks
Secondary Outcome Measure Information:
Title
The executive function in real life of schoolage child of ADHD
Description
The executive function in real life of schoolage children of ADHD assessed by BRIEF
Time Frame
through the intervention completion, an average of 12 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 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
meet both the criteria of ADHD based on the interview by the CDIS and clinical diagnosis with DSM-5;
full-scale IQ estimated bythe Wechsler Intelligence Scale for Children-Revised Form (WISC-R) 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.;
parents with severe mental illness, such as schizophrenia, mood disorder (period of onset), etc..
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meihui Qiu, Master
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
Learn more about this trial
A Randomized Controlled Study of Family Based EF Training for Schoolage Children With ADHD
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