A Randomized Controlled Study of MEFP for Preschool Children With ADHD

ADHD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03515135
• Other study ID #: XH-17-003
• Status: Completed
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: December 30, 2018

Study information

• Verified date: March 2020
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: December 30, 2018
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 6 Years

Eligibility

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..

Related Conditions & MeSH terms

• ADHD
• Child, Only

Intervention

Behavioral:
• Metacognitive 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.

Locations

Country	Name	City	State
China	Xinhua Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	The ADHD symptoms of child	The ADHD symptoms of child assessed by SNAP	through the intervention completion, an average of 8 weeks