Intensive Executive Function Training

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

A Randomized Controlled Study on the Effect of Intensive Functional Training on Children With Attention Deficit Hyperactivity Disorder

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02656758
• Other study ID #: Z151100004015103
• Status: Enrolling by invitation
• Phase: N/A
• First received: January 11, 2016
• Last updated: October 9, 2016
• Start date: January 2016
• Est. completion date: December 2018

Study information

• Verified date: October 2016
• Source: Peking University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The investigators intent to recruit 80 attention deficit hyperactivity disorder families. The attention deficit hyperactivity disorder families had received executive function training one year before.They will be randomized to intervention group and control group using a block randomization design. The intervention group will participate in intensive executive function training immediately,while the control group will receive executive training after 3 months.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 80
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

Inclusion Criteria:

• clinical diagnosis of child attention deficit hyperactivity disorder

• full-scale intelligence quotient (FSIQ) =70

• stable on medication for attention deficit hyperactivity disorder children at least 3 months

• participation in the early implementation of functional training one year before

Exclusion Criteria:

• individuals with major neurological disorders

• a diagnosis of schizophrenia, epilepsy, mental retardation or other brain disorders

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

Behavioral:
• intensive Executive function training
Children diagnosis of attention deficit hyperactivity disorder are randomized to the experimental condition(Executive Function training) or waiting group experimental:participants will receive 12 sessions of intensive executive function training weekly no intervention :waiting participants will not be treated with intensive executive function training and keep waiting for 12 weeks for comparison

Locations

Country	Name	City	State
China	Peking University Sixth Hospital/Institute of Mental Health	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
ZIli Fan

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in attention deficit hyperactivity disorder-rating scale		baseline, after the training (12 weeks)	No
Secondary	Change in behavior rating scale of executive function		baseline, after the training (12 weeks)	No
Secondary	Cambridge Neuropsychological Test Automatic Battery		baseline, after the training (12 weeks)	No
Secondary	Behavior Rating Inventory of Executive Function		baseline, after the training (12week)	No