A Randomized Controlled Study of Family Based EF Training for Schoolage Children With ADHD

Family Based Executive Function Training for Schoolage Children With ADHD - A Randomized Controlled Study

The goal of this study is to provide a new treatment approach for schoolage children with ADHD, which could facilitate the EF developing well to achieve better outcome.

Study Overview

• Status: Active, not recruiting
• Conditions: ADHD; Child, Only
• Intervention / Treatment: Behavioral: Family based Executive Function Training

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. Although medication showed significant effectiveness in controlling the core symptoms of ADHD, it failed to help patients master compensatory strategies to cope with functional impairments in learning and life events. The family intervention program for school-age ADHD children is still rare, and it is a blank field in China. At present, most of these related studies have not integrated task training in realistic scenarios with parent training, and lack of randomized and controlled Settings, which makes the effect of intervention less convincing. Therefore, the investigators conduct this randomized and controlled study to find out the therapeutic efficacy of Family-based Executive Function Training for Schoolage Children with ADHD, 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 treatment approach for schoolage children with ADHD, which could facilitate the EF developing well to achieve better outcome.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200092
    • Xinhua Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 11 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. meet both the criteria of ADHD based on the interview by the CDIS and clinical diagnosis with DSM-5;
2. full-scale IQ estimated bythe Wechsler Intelligence Scale for Children-Revised Form (WISC-R) 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. parents with severe mental illness, such as schizophrenia, mood disorder (period of onset), etc..

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Subjects in this group will receive the "Famliy based Executive Function Training " program in aiming to reduce ADHD symptoms and improve the executive function.	Behavioral: Family based Executive Function Training; Training the executive funtions of shcoolage ADHD children through tasks and games repeatly but with fun. Giving the parental training and support for the parenting role parents strategies to help the shcoolage ADHD childred coping the symptoms and develop EF in the reallife and improve parent-child relationship.
No Intervention: Waiting group; Subjects in this group will not receive the "Famliy based Executive Function Training " program during the study period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The executive function of of schoolage child of ADHD	The core symptoms of schoolage children of ADHD assessed by neuropsychological evaluation tool NEPSY	through the intervention completion, an average of 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The executive function in real life of schoolage child of ADHD	The executive function in real life of schoolage children of ADHD assessed by BRIEF	through the intervention completion, an average of 12 weeks
The ADHD symptoms of child	The ADHD symptoms of child assessed by SNAP	through the intervention completion, an average of 12 weeks

Collaborators and Investigators

• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Investigators: Principal Investigator: Meihui Qiu, Master, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Anticipated): February 6, 2022
• Study Completion (Anticipated): February 6, 2022

Study Registration Dates

• First Submitted: August 25, 2021
• First Submitted That Met QC Criteria: August 25, 2021
• First Posted (Actual): August 27, 2021

Study Record Updates

• Last Update Posted (Actual): August 27, 2021
• Last Update Submitted That Met QC Criteria: August 25, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: ADHD; executive function; family-based intervention; schoolage
• Other Study ID Numbers: XH-21-006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No