A Randomized Controlled Study of MEFP for Preschool Children With ADHD

• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT03515135
• Collaborator: (none)
• Enrollment: 96
• Location: 1
• Arms: 2
• Actual Duration (Months): 19
• Patients Per Site Per Month: 5.1

Study Details

Study Description

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	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 96 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: Jun 1, 2017
• Actual Primary Completion Date: Dec 30, 2018
• Actual Study Completion Date: Dec 30, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. The executive function of preschool child of ADHD [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 [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 [through the intervention completion, an average of 8 weeks]

   The ADHD symptoms of child assessed by SNAP

Eligibility Criteria

Criteria

• Ages Eligible for Study: 4 Years to 6 Years
• Sexes Eligible for Study: All
• Accepts 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..

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Xinhua Hospital	Shanghai		China	200092

Sponsors and Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Investigators

• Principal Investigator: Lan Shuai, Ph.D, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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
• Other Study ID Numbers: XH-17-003
• First Posted: May 3, 2018
• Last Update Posted: Mar 18, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Jinsong Zhang, Director of Department of Medical Psychology, Department of Developmental Behavioral and Child Healthcare, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: ADHD; executive function; preschool; intervention

Study Results

No Results Posted as of Mar 18, 2020