Skip to main content
OpenTrials
Completed

NCT Number: NCT03515135

A Randomized Controlled Study of MEFP for Preschool Children With ADHD

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

4 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xinhua Hospital

Shanghai, 200092, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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..

Treatment and study plan

Metacognitive Executive Function Training

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.

Primary outcomes

  1. 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

  1. The executive function in real life of preschool child of ADHD

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

    The executive function in real life of preschool children of ADHD assessed by BRIEF

  2. The ADHD symptoms of child

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

    The ADHD symptoms of child assessed by SNAP

Sponsors and collaborators

Lead sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 3, 2018
Registry last updated
Mar 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.