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

ADHD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05025501
• Other study ID #: XH-21-006
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: February 6, 2022

Study information

• Verified date: July 2021
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: February 6, 2022
• Est. primary completion date: February 6, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 11 Years

Eligibility

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..

Related Conditions & MeSH terms

• ADHD
• Child, Only

Intervention

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.

Locations

Country	Name	City	State
China	Xinhua Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	The ADHD symptoms of child	The ADHD symptoms of child assessed by SNAP	through the intervention completion, an average of 12 weeks