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

Not Applicable

• Conditions: ADHD; Child, Only
• Interventions: Behavioral: Family based Executive Function Training

• Registration Number: NCT05025501
• Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Brief Summary

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.

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 Timeline

• Study Start: 2021-02-01
• Status Verified: 2021-07
• Study First Submitted: 2021-08-25
• Study First Submitted QC: 2021-08-25
• Last Update Submitted: 2021-08-25
• Study First Posted: 2021-08-27
• Last Update Posted: 2021-08-27
• Primary Completion: 2022-02-06
• Study Completion: 2022-02-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Family based Executive Function Training	Subjects in this group will receive the "Famliy based Executive Function Training " program in aiming to reduce ADHD symptoms and improve the executive function.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Xinhua Hospital; 🇨🇳 Shanghai, China