Back to resultsIntensive Executive Function Training
Primary Purpose
Attention Deficit Hyperactivity Disorder
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
intensive Executive function training
Sponsored by
About this trial
This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder
Eligibility Criteria
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
Sites / Locations
- Peking University Sixth Hospital/Institute of Mental Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Executive function training
the waitlist group
Arm Description
the experimental group will receive 12 sessions of intensive Executive function training weekly immediately
the waitlist group will wait 12 weeks before receiving intensive executive function training for comparison.
Outcomes
Primary Outcome Measures
Change in attention deficit hyperactivity disorder-rating scale
Secondary Outcome Measures
Change in behavior rating scale of executive function
Cambridge Neuropsychological Test Automatic Battery
Behavior Rating Inventory of Executive Function
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02656758
Brief Title
Intensive Executive Function Training
Official Title
A Randomized Controlled Study on the Effect of Intensive Functional Training on Children With Attention Deficit Hyperactivity Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
ZIli Fan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Executive function training
Arm Type
Experimental
Arm Description
the experimental group will receive 12 sessions of intensive Executive function training weekly immediately
Arm Title
the waitlist group
Arm Type
Other
Arm Description
the waitlist group will wait 12 weeks before receiving intensive executive function training for comparison.
Intervention Type
Behavioral
Intervention Name(s)
intensive Executive function training
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in attention deficit hyperactivity disorder-rating scale
Time Frame
baseline, after the training (12 weeks)
Secondary Outcome Measure Information:
Title
Change in behavior rating scale of executive function
Time Frame
baseline, after the training (12 weeks)
Title
Cambridge Neuropsychological Test Automatic Battery
Time Frame
baseline, after the training (12 weeks)
Title
Behavior Rating Inventory of Executive Function
Time Frame
baseline, after the training (12week)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ying Qian
Organizational Affiliation
Peking University Sixth Hospital/Institute of Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University Sixth Hospital/Institute of Mental Health
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
12. IPD Sharing Statement
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Intensive Executive Function Training
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