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Clinical Trials/NCT05025501
NCT05025501
Unknown
Not Applicable

Family Based Executive Function Training for Schoolage Children With ADHD - A Randomized Controlled Study

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine1 site in 1 country100 target enrollmentFebruary 1, 2021
ConditionsADHDChild, Only

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
ADHD
Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Enrollment
100
Locations
1
Primary Endpoint
The executive function of of schoolage child of ADHD
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2021
End Date
February 6, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

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..

Outcomes

Primary Outcomes

The executive function of of schoolage child of ADHD

Time Frame: through the intervention completion, an average of 12 weeks

The core symptoms of schoolage children of ADHD assessed by neuropsychological evaluation tool NEPSY

Secondary Outcomes

  • The ADHD symptoms of child(through the intervention completion, an average of 12 weeks)
  • The executive function in real life of schoolage child of ADHD(through the intervention completion, an average of 12 weeks)

Study Sites (1)

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