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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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ADHD, Child, Only

Intervention / Treatment
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* Behavioral: Family based Executive Function Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: meet both the criteria of ADHD based on the interview by the CDIS and clinical diagnosis with DSM-5; full-scale IQ estimated bythe Wechsler Intelligence Scale for Children-Revised Form (WISC-R) above 80; their parents volunteered to participate in this study. Exclusion Criteria: 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.; parents with severe mental illness, such as schizophrenia, mood disorder (period of onset), etc..

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>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<br>* 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.<br>|
| No Intervention: Waiting group<br>Subjects in this group will not receive the Famliy based Executive Function Training  program during the study period. | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADHD, executive function, schoolage, family-based intervention