A Randomized Controlled Study of MEFP for Preschool Children With ADHD

NCT03515135 | Completed DMC

• 1 other identifier: XH-17-003
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

ADHD; Child, Only

Keywords

ADHD; executive function; preschool; intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• The executive function in real life of preschool child of ADHD

  through the intervention completion, an average of 8 weeks

• The ADHD symptoms of child

  through the intervention completion, an average of 8 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Behavioral: Metacognitive Executive Function Training

Waiting group

NO INTERVENTION

Subjects in this group will not receive the MEFP program during the study period.

Interventions

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.

Intervention group

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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..

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Xinhua Hospital

Shanghai, 200092, China

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Lan Shuai, Ph.D

  Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Medical Psychology, Department of Developmental Behavioral and Child Healthcare

Study Record Dates

• First Submitted: November 7, 2017
• First Posted: May 3, 2018
• Study Start: June 1, 2017
• Primary Completion: December 30, 2018
• Study Completion: December 30, 2018
• Last Updated: March 18, 2020

Record last verified: 2020-03

Locations

CN (1)