Intensive Executive Function Training

October 9, 2016 updated by: ZIli Fan

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100191
        • Peking University Sixth Hospital/Institute of Mental Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in attention deficit hyperactivity disorder-rating scale
Time Frame: baseline, after the training (12 weeks)
baseline, after the training (12 weeks)

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in behavior rating scale of executive function
Time Frame: baseline, after the training (12 weeks)
baseline, after the training (12 weeks)
Cambridge Neuropsychological Test Automatic Battery
Time Frame: baseline, after the training (12 weeks)
baseline, after the training (12 weeks)
Behavior Rating Inventory of Executive Function
Time Frame: baseline, after the training (12week)
baseline, after the training (12week)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ZIli Fan

Investigators

  • Principal Investigator: Ying Qian, Peking University Sixth Hospital/Institute of Mental Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

January 11, 2016

First Submitted That Met QC Criteria

January 14, 2016

First Posted (Estimate)

January 15, 2016

Study Record Updates

Last Update Posted (Estimate)

October 11, 2016

Last Update Submitted That Met QC Criteria

October 9, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Z151100004015103

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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