Intensive Executive Function Training
A Randomized Controlled Study on the Effect of Intensive Functional Training on Children With Attention Deficit Hyperactivity Disorder
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
January 11, 2016
CompletedFirst Posted
Study publicly available on registry
January 15, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedOctober 11, 2016
October 1, 2016
1.9 years
January 11, 2016
October 9, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Change in attention deficit hyperactivity disorder-rating scale
baseline, after the training (12 weeks)
Secondary Outcomes (3)
Change in behavior rating scale of executive function
baseline, after the training (12 weeks)
Cambridge Neuropsychological Test Automatic Battery
baseline, after the training (12 weeks)
Behavior Rating Inventory of Executive Function
baseline, after the training (12week)
Study Arms (2)
Executive function training
EXPERIMENTALthe experimental group will receive 12 sessions of intensive Executive function training weekly immediately
the waitlist group
OTHERthe waitlist group will wait 12 weeks before receiving intensive executive function training for comparison.
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- individuals with major neurological disorders
- a diagnosis of schizophrenia, epilepsy, mental retardation or other brain disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ZIli Fanlead
Study Sites (1)
Peking University Sixth Hospital/Institute of Mental Health
Beijing, Beijing Municipality, 100191, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ying Qian
Peking University Sixth Hospital/Institute of Mental Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- postgraduate
Study Record Dates
First Submitted
January 11, 2016
First Posted
January 15, 2016
Study Start
January 1, 2016
Primary Completion
December 1, 2017
Study Completion
December 1, 2018
Last Updated
October 11, 2016
Record last verified: 2016-10