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Clinical Trials/NCT03515135
NCT03515135
Completed
Not Applicable

Metacognitive Executive Function Training for Preschool Children With ADHD - A Randomized Controlled Study

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine1 site in 1 country96 target enrollmentJune 1, 2017
ConditionsADHDChild, Only

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
ADHD
Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Enrollment
96
Locations
1
Primary Endpoint
The executive function of preschool child of ADHD
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2017
End Date
December 30, 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jinsong Zhang

Director of Department of Medical Psychology, Department of Developmental Behavioral and Child Healthcare

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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..

Outcomes

Primary Outcomes

The executive function of preschool child of ADHD

Time Frame: through the intervention completion, an average of 8 weeks

The executive function of preschool children of ADHD assessed by neuropsychological evaluation tool NEPSY

Secondary Outcomes

  • The executive function in real life of preschool child of ADHD(through the intervention completion, an average of 8 weeks)
  • The ADHD symptoms of child(through the intervention completion, an average of 8 weeks)

Study Sites (1)

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