A Randomized Controlled Study of MEFP for Preschool Children With ADHD

Study Overview
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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.

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.

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

Conditions
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ADHD, Child, Only

Intervention / Treatment
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* Behavioral: Metacognitive Executive Function Training


Participation Criteria
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Eligibility Criteria
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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..

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Subjects in this group will receive the Metacognitive Executive Function Training (MEFP) program in aiming to reduce ADHD symptoms and improve the executive function. | Behavioral: Metacognitive Executive Function Training<br>* 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.<br>|
| No Intervention: Waiting group<br>Subjects in this group will not receive the MEFP program during the study period. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The executive function of preschool child of ADHD | The executive function of preschool children of ADHD assessed by neuropsychological evaluation tool NEPSY | through the intervention completion, an average of 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | through the intervention completion, an average of 8 weeks | 
| The ADHD symptoms of child | The ADHD symptoms of child assessed by SNAP | through the intervention completion, an average of 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADHD, executive function, preschool, intervention