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

NCT ID: NCT05025501

Last Updated: 2021-08-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2022-02-06

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.

Conditions

ADHD; Child, Only

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Family based Executive Function Training

Intervention Type: BEHAVIORAL

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.

Waiting group

Subjects in this group will not receive the "Famliy based Executive Function Training " program during the study period.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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..

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Meihui Qiu, Master

Role: PRINCIPAL_INVESTIGATOR

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Locations

Xinhua Hospital

Shanghai, , China

Countries

China

Other Identifiers

XH-21-006

Identifier Type: -

Identifier Source: org_study_id