A Randomized Controlled Study of MEFP for Preschool Children With ADHD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-01

Study Completion Date

2018-12-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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ADHD Child, Only

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention group

Subjects in this group will receive the "Metacognitive Executive Function Training (MEFP)" program in aiming to reduce ADHD symptoms and improve the executive function.

Group Type EXPERIMENTAL

Metacognitive Executive Function Training

Intervention Type BEHAVIORAL

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.

Waiting group

Subjects in this group will not receive the MEFP program during the study period.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Metacognitive Executive Function Training

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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..

Minimum Eligible Age

4 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes