Clinical trial NCT03515135: A Randomized Controlled Study of MEFP for Preschool Children With ADHD
Official title: Metacognitive Executive Function Training for Preschool Children With ADHD - A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ADHD
Child, Only
Keywords: ADHD
executive function
preschool
intervention
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2018-05-03
Enrollment: 96
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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..

Primary outcomes:
measure: The executive function of preschool child of ADHD
timeFrame: through the intervention completion, an average of 8 weeks
Secondary outcomes:
measure: The executive function in real life of preschool child of ADHD
timeFrame: through the intervention completion, an average of 8 weeks
measure: The ADHD symptoms of child
timeFrame: through the intervention completion, an average of 8 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xinhua Hospital
Study officials:
affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Lan Shuai, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: