A Randomized Controlled Study of MEFP for Preschool Children With ADHD

Not Applicable

Completed

• Conditions: Child, Only; ADHD
• Interventions: Behavioral: Metacognitive Executive Function Training

• Registration Number: NCT03515135
• Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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.

Study Timeline

• Study Start: 2017-06-01
• Study First Submitted: 2017-11-07
• Study First Submitted QC: 2018-04-21
• Study First Posted: 2018-05-03
• Primary Completion: 2018-12-30
• Study Completion: 2018-12-30
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-16
• Last Update Posted: 2020-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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..

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
The executive function of preschool child of ADHD	through the intervention completion, an average of 8 weeks	The executive function of preschool children of ADHD assessed by neuropsychological evaluation tool NEPSY

Secondary Outcome Measures

Name	Time	Method
The executive function in real life of preschool child of ADHD	through the intervention completion, an average of 8 weeks	The executive function in real life of preschool children of ADHD assessed by BRIEF
The ADHD symptoms of child	through the intervention completion, an average of 8 weeks	The ADHD symptoms of child assessed by SNAP

Trial Locations

Locations (1)

Xinhua Hospital; 🇨🇳 Shanghai, China