This research aimed to investigate the effect of neurofeedback training on aggression and impulsivity in elementary boy students with attention deficit / hyperactivity disorder.
Design
Totally from between elementary boy students with attention deficit / hyperactivity disorder 40 students were selected through available sampling method and randomly assigned to two equal group (each group 20 person).
Settings and conduct
The statistical population included all elementary boy students with attention deficit / hyperactivity disorder that referred to counseling centers of Pakdasht city in 2016 year.
Participants/Inclusion and exclusion criteria
Inclusion criteria were included lack of mental retardation, significant drop in one of the areas of education, no disorder caused by brain damage, cutting the score of attention deficit / hyperactivity disorder and exclusion criteria were included absence of more than two sessions at the same time receiving treatment was another.
Intervention groups
]ntervention of this research was neurofeedback training that 12 sessions of 60 minutes educated to expremental group and the control group was put on a waiting list for training.
Main outcome variables
The primary consequence of this research was increasing health of elementary school boys with attention deficit / hyperactivity disorder and decreasing aggression and impulsivity of elementary school boys with attention deficit / hyperactivity disorder
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160717028964N2
Registration date:2018-01-09, 1396/10/19
Registration timing:prospective
Last update:2018-01-09, 1396/10/19
Update count:0
Registration date
2018-01-09, 1396/10/19
Registrant information
Name
Pooria Sarvghadi
Name of organization / entity
Faculty of Rehabilitation, Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3502 3238
Email address
sarvghadi.pooria@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Personal expenses
Expected recruitment start date
2018-01-17, 1396/10/27
Expected recruitment end date
2018-03-18, 1396/12/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of neurofeedback training on aggression and impulsivity in elementary boy students with attention deficit / hyperactivity disorders
Public title
neurofeedback on aggression and impulsivity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
the absence of mental retardation
Having an age of 6-12 years
Exclusion criteria:
having learning disorders
taking medication or receiving other therapies at the same time
Age
From 6 years old to 12 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
participants replaced with random numbers table in the experimental and control groups
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Mashhad, Mashhad University of Medical Sciences
City
Mashahd
Province
Razavi Khorasan
Postal code
9179646731
Approval date
2017-11-22, 1396/09/01
Ethics committee reference number
IR.MUMS.SM.REC.1396.548
Health conditions studied
1
Description of health condition studied
Attention deficit / hyperactivity disorders
ICD-10 code
F99
ICD-10 code description
Mental disorder, not otherwise specified
Primary outcomes
1
Description
aggression and impulsivity
Timepoint
2 month
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
neurofeedback training to intervention group: Neurofeedback training to intervention group was
12 sessions of 60-minute that was conducted individually and in cooperation with the accompaniment of Neurotrapyst
Category
Rehabilitation
2
Description
The control group will be on a waiting list in case of a positive result for their use of neurofeedback
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Counseling Centers of Pakdasht
Full name of responsible person
Jamal Ashoori
Street address
Nomber 9, Alley Almahdi 4, St. Shohadaye School, City Pishva, Tehran
City
Pakdasht
Province
Tehran
Postal code
3381938455
Phone
+98 21 3673 0498
Email
jamal_ashoori@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research of Mashhad University of Medical Sciences
Full name of responsible person
Jamal Ashoori
Street address
Nomber 9, Alley Almahdi 4, St. Shohadaye School, City Pishva, Tehran
City
Pishva
Province
Tehran
Postal code
3381938455
Phone
+98 21 3673 0498
Email
jamal_ashoori@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research of Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University of Isfahan (Khorasgan)
Full name of responsible person
Jamal Ashoori
Position
Ph.D
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Nomber 9, Alley Almahdi 4, St. Shohadaye School, City Pishva, Tehran
City
Pishva
Province
Tehran
Postal code
33819358455
Phone
+98 21 3673 0498
Fax
Email
jamal_ashoori@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University of of Isfahan (Khorasgan) Branch
Full name of responsible person
Jamal Ashoori
Position
Ph.d
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Nomber 9, Alley Almahdi 4, St. Shohadaye School, City Pishva, Tehran
City
Pishva
Province
Tehran
Postal code
3381938455
Phone
+98 21 3673 0498
Fax
Email
jamal_ashoori@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University of Isfahan (Khorasgan)
Full name of responsible person
Jamal Ashoori
Position
Ph.D
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Nomber 9, Alley Almahdi 4, St. Shohadaye School, City Pishva, Tehran
City
Pishva
Province
Tehran
Postal code
3381938455
Phone
+98 21 3673 0498
Fax
Email
jamal_ashoori@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Keeping the IPD deidentified has been our policy as we have declared it in our informed consent forms, seen and signed by our patients.
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
all collected deidentified IPD can be shared.
When the data will become available and for how long
The findings of this research project are going to be submitted for publication within the next year probably with a title such as:
"Efficacy of Neurofeedback Training on Aggression and Impulsivity in Male Elementary School Children with Attention Deficit/Hyperactivity Disorder"
To whom data/document is available
The published data will be available online. We will also be ready to share the raw deidentified individual participant data for further cumulative studies as well.
Under which criteria data/document could be used
When necessary, the raw deidentified IPD can be shared for registered researches such as Meta-analyses.
From where data/document is obtainable
Enquiries from registered research projects for raw deidentified IPD can be sent to the following Email:
sarvghadi.pooria@sbmu.ac.ir
What processes are involved for a request to access data/document
The raw deidentified IPD can be Emailed once the enquiries from registered research projects are double confirmed with the corresponding registry.