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Intensive Executive Function Training

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ClinicalTrials.gov Identifier: NCT02656758
Recruitment Status : Unknown
Verified October 2016 by ZIli Fan, Peking University.
Recruitment status was:  Enrolling by invitation
First Posted : January 15, 2016
Last Update Posted : October 11, 2016
Sponsor:
Information provided by (Responsible Party):
ZIli Fan, Peking University

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.

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Behavioral: intensive Executive function training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Study on the Effect of Intensive Functional Training on Children With Attention Deficit Hyperactivity Disorder
Study Start Date : January 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Executive function training
the experimental group will receive 12 sessions of intensive Executive function training weekly immediately
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

the waitlist group
the waitlist group will wait 12 weeks before receiving intensive executive function training for comparison.
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




Primary Outcome Measures :
  1. Change in attention deficit hyperactivity disorder-rating scale [ Time Frame: baseline, after the training (12 weeks) ]

Secondary Outcome Measures :
  1. Change in behavior rating scale of executive function [ Time Frame: baseline, after the training (12 weeks) ]
  2. Cambridge Neuropsychological Test Automatic Battery [ Time Frame: baseline, after the training (12 weeks) ]
  3. Behavior Rating Inventory of Executive Function [ Time Frame: baseline, after the training (12week) ]


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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02656758


Locations
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China, Beijing
Peking University Sixth Hospital/Institute of Mental Health
Beijing, Beijing, China, 100191
Sponsors and Collaborators
ZIli Fan
Investigators
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Principal Investigator: Ying Qian Peking University Sixth Hospital/Institute of Mental Health

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Responsible Party: ZIli Fan, postgraduate, Peking University
ClinicalTrials.gov Identifier: NCT02656758     History of Changes
Other Study ID Numbers: Z151100004015103
First Posted: January 15, 2016    Key Record Dates
Last Update Posted: October 11, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
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Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms