Intensive Executive Function Training

Sponsor

ZIli Fan (Other)

Overall Status

Unknown status

CT.gov ID

NCT02656758

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Attention Deficit Hyperactivity Disorder	Behavioral: intensive Executive function training	N/A

Study Design

Study Type:

Interventional

Anticipated 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 :

Jan 1, 2016

Anticipated Primary Completion Date :

Dec 1, 2017

Anticipated Study Completion Date :

Dec 1, 2018

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change in attention deficit hyperactivity disorder-rating scale [baseline, after the training (12 weeks)]

Secondary Outcome Measures

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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking University Sixth Hospital/Institute of Mental Health	Beijing	Beijing	China	100191

Sponsors and Collaborators

ZIli Fan

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

ZIli Fan, postgraduate, Peking University

ClinicalTrials.gov Identifier:

NCT02656758

Other Study ID Numbers:

Z151100004015103

First Posted:

Jan 15, 2016

Last Update Posted:

Oct 11, 2016

Last Verified:

Oct 1, 2016

Additional relevant MeSH terms:

Hyperkinesis

Attention Deficit Disorder with Hyperactivity

Study Results

No Results Posted as of Oct 11, 2016