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A Randomized Controlled Study of MEFP for Preschool Children With ADHD

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03515135
Enrollment
96
Registered
2018-05-03
Start date
2017-06-01
Completion date
2018-12-30
Last updated
2020-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ADHD, Child, Only

Keywords

ADHD, executive function, preschool, intervention

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.

Interventions

BEHAVIORALMetacognitive 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.

Sponsors

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
4 Years to 6 Years
Healthy volunteers
Yes

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..

Design outcomes

Primary

MeasureTime frameDescription
The executive function of preschool child of ADHDthrough the intervention completion, an average of 8 weeksThe executive function of preschool children of ADHD assessed by neuropsychological evaluation tool NEPSY

Secondary

MeasureTime frameDescription
The executive function in real life of preschool child of ADHDthrough the intervention completion, an average of 8 weeksThe executive function in real life of preschool children of ADHD assessed by BRIEF
The ADHD symptoms of childthrough the intervention completion, an average of 8 weeksThe ADHD symptoms of child assessed by SNAP

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026