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

NCT05025501 | Unknown

• 1 other identifier: XH-21-006
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

ADHD; Child, Only

Keywords

ADHD; executive function; schoolage; family-based intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• The executive function in real life of schoolage child of ADHD

  through the intervention completion, an average of 12 weeks

• The ADHD symptoms of child

  through the intervention completion, an average of 12 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Waiting group

NO INTERVENTION

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

Interventions

Family based Executive Function Training 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.

Intervention group

Eligibility Criteria

• Age: 7 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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..

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Xinhua Hospital

Shanghai, 200092, China

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Meihui Qiu, Master

  Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2021
• First Posted: August 27, 2021
• Study Start: February 1, 2021
• Primary Completion: February 6, 2022
• Study Completion: February 6, 2022
• Last Updated: August 27, 2021

Record last verified: 2021-07

Locations

CN (1)