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A Randomized Controlled Study of MEFP for Preschool Children With ADHD

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ClinicalTrials.gov Identifier: NCT03515135
Recruitment Status : Enrolling by invitation
First Posted : May 3, 2018
Last Update Posted : May 10, 2018
Sponsor:
Information provided by (Responsible Party):
Jinsong Zhang, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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.

Condition or disease Intervention/treatment Phase
ADHD Child, Only Behavioral: Metacognitive Executive Function Training Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Metacognitive Executive Function Training for Preschool Children With ADHD - A Randomized Controlled Study
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Toddler Health

Arm Intervention/treatment
Experimental: Intervention group
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
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.

No Intervention: Waiting group
Subjects in this group will not receive the MEFP program during the study period.



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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..

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03515135


Locations
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China
Xinhua Hospital
Shanghai, China, 200092
Sponsors and Collaborators
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Investigators
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Principal Investigator: Lan Shuai, Ph.D Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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Responsible Party: Jinsong Zhang, Director of Department of Medical Psychology, Department of Developmental Behavioral and Child Healthcare, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT03515135     History of Changes
Other Study ID Numbers: XH-17-003
First Posted: May 3, 2018    Key Record Dates
Last Update Posted: May 10, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jinsong Zhang, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine:
ADHD
executive function
preschool
intervention