A Randomized Controlled Study of MEFP for Preschool Children With ADHD

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine96 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Enrollment

Conditions

ADHD Child, Only

Interventions

Metacognitive Executive Function TrainingBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 4 YearsMax age: 6 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. meet both the criteria of ADHD based on the interview by the DIPA and clinical diagnosis with DSM-5; 2. full-scale IQ estimated by the Wechsler Primary and Preschool Scale of Intelligence (WPPSI) above 80; 3. their parents volunteered to participate in this study. Exclusion Criteria: 1. 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.; 2. receive medication intervention for their ADHD symptoms before study; 3. parents with severe mental illness, such as schizophrenia, mood disorder (period of onset), etc..

Locations (1)

Xinhua Hospital

Shanghai, China

Outcomes

Primary Outcomes

The executive function of preschool child of ADHD

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 Outcomes

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

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

The ADHD symptoms of child

The ADHD symptoms of child assessed by SNAP

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

Data from ClinicalTrials.gov

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