Comparing the efficacy of methods of Neurofeedback, Neurofeedback and Barkly's Parent Training, Neurofeedback and Computerized Coginetive Rehabilitation on children with Attention -Deficit/Hyperactivity Disorder
Comparing the efficacy of Neurofeedback, Neurofeedback and Barkly's Parent Training, Neurofeedback and Computerized Cognitive Rehabilitation on children with ADHD
Design
Quasi-experimental study with pretest- post test and follow up by control group
In this study 56 ADHD children referring to education concealing center with entrance criteria will be chosen purposefully and randomly divided to 3 experimental groups and 1 control group
Settings and conduct
In this single–blind clinical trial with pretest- posttest, after random sampling and arranging groups , pre-test will be performed for all groups . Then Neurofeedback group will have 30 sessions training 3 times a week each secession 30 minutes. second group, beside Neurofeedback, will have 9 session parental training for 60 minutes once a week. The third group beside Neurofeedback , there will be 15 sessions Computerized Cognitive Rehabilitation training for 30 minutes 3 times a week. Control group will have sham sessions for 30 minutes 3 times a week.
Experiment place:Isfahan educational counseling center
Participants/Inclusion and exclusion criteria
Elementary ADHD boys in Isfahan
Including criteria:
psychiatrist diagnosis of ADHD
Being in Elementary school
Having IQ more than 85 score according to Wechsler IQ test
No using drugs affecting the CNS
completing informed consent form
Being boy
Age group 6-13 years old
Excluding criteria:
Having other psychiatric and cognetive disorders
Having Epileptic seizure in last two years
Intervention groups
Only Neurofeedback training
Neurofeedback and Barkly's Parent training
Neurofeedback and Computerized Cognitive Rehabilitation training
control group
Main outcome variables
Attention deficit
hyperactivity
General information
Reason for update
Acronym
ADHD
IRCT registration information
IRCT registration number:IRCT20180106038230N1
Registration date:2018-06-30, 1397/04/09
Registration timing:retrospective
Last update:2018-06-30, 1397/04/09
Update count:0
Registration date
2018-06-30, 1397/04/09
Registrant information
Name
Elahe Hajeforoush
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3630 3512
Email address
e.hajeforoush@khuisf.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2018-06-20, 1397/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the efficacy of methods of Neurofeedback, Neurofeedback and Barkly's Parent Training, Neurofeedback and Computerized Coginetive Rehabilitation on children with Attention -Deficit/Hyperactivity Disorder
Public title
Comparing the efficacy of Neurofeedback and combined treatments in ADHD
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
psychiatrist diagnosis of ADHD
Being an Elementary school student
Having IQ more than 85score according to Wechsler IQ test
No using drugs affecting the CNS
completing informed consent form
Being male
Age group 6 to 13 years
Exclusion criteria:
Having other psychiatric and cognitive- neurological disorders
having Epileptic seizure in the last two years
Age
From 6 years old to 13 years old
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
56
Actual sample size reached:
48
Randomization (investigator's opinion)
Randomized
Randomization description
According to entrance criteria fifty six individuals will be selected from available sample community then assigned randomly based on equal chance and in sequential drawing to 4 experiment groups including group 1,2,3 and the control group. Each group will be included 14 members. Nobody knows anything about the participants’ list and numbers except the researcher.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study control group participants will have sham, however they will be unaware, their parents are aware. Also the statistical analyzer has no data about the research process.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad university Isfahan(Khorasgan) branch
Street address
Daneshgah Blvd, Arghavanyeh, East Jey Ave, Azad Islamic Univercity Isfahan(Khorasgan) branch
City
Isfahan
Province
Isfehan
Postal code
٨١٥٥١٣٩٩٩٨
Approval date
2018-04-16, 1397/01/27
Ethics committee reference number
IR.IAU.KHU.IF.1397-27
Health conditions studied
1
Description of health condition studied
Attention Deficit Hyperactivity Disorder
ICD-10 code
F90
ICD-10 code description
Attention-deficit hyperactivity disorders
Primary outcomes
1
Description
Symptoms of ADHD measured by IVA+ PLUS test
Timepoint
Pretest,two and a half month post test & two and a half month follow up
Method of measurement
Integrative Visual and Auditory performance test
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: Only Neurofeedback training, the intervention will be performed during 30 training sessions 3 days per week and each session will be lasted 30 minutes using a set of Procomp 2 and BioGraph INFINITI software made by Canada (having treatment protocol based on BioGraph INFINITI baseline).
Category
Rehabilitation
2
Description
Second intervention group: Neurofeedback and Barkly Parental training. The intervention will be performed during 30 training sessions 3 days per week and each session will be lasted 30 minutes using the set of Procomp 2 and BioGraph INFINITI software made by Canada (having treatment protocol based on BioGraph INFINITI baseline), beside 9 session Barckly parental training for 60 minutes once in a week.
Category
Rehabilitation
3
Description
The third intervention group: Neurofeedback and Computerized Cognitive Rehabilitation training,This group will have 30 sessions training, 3 days per week and each session will be lasted 30 minutes using the set of Procomp 2 and BioGraph INFINITI software made by Canada (having treatment protocol based on BioGraph INFINITI baseline), beside, 15 session Computerized Cognitive Rehabilitation training for 30 minutes 3 times a week by Cogiplus software made by SCHUHFRIED company in Austria.
Category
Rehabilitation
4
Description
Control group:The intervention will be performed during 30 sham training sessions, 3 days per week and each session will be lasted 30 minutes using the set of Procomp 2 and BioGraph INFINITI software made by Canada.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Concelling Center of Isfehan Educational Administration Region 2
Full name of responsible person
Zahra Kashefi
Street address
Concelling Center of Isfehan Educational Administration Region 2 ,Nasr Ave, Bozorgmehr street
City
Isfehan
Province
Isfehan
Postal code
٨١٥٣٩٧٦٧٩٩
Phone
+98 31 3267 4328
Email
zahra_ka52@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Majid Toghiani
Street address
Daneshgah Blvd, Arghavanyeh, East Jey Street, Islamic Azad university Isfehan ( Khorasgan) branch
City
Isfahan
Province
Isfehan
Postal code
٨١٥٥١٣٩٩٩٨
Phone
+98 31 3500 2551
Email
toghiani@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Private
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
Esfahan University of Medical Sciences
Full name of responsible person
Elahe Hajeforoush
Position
PHD student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No.4 Aseman Flat, Harandizade Dead end, Majlesi Allay, 2Apadana Ave,
City
Isfahan
Province
Isfehan
Postal code
8166763631
Phone
+98 31 3630 3512
Fax
Email
E.Hajeforoush@khuisf.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Elahe Hajeforoush
Position
PHD student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No.4 Aseman Flat, Harandizade Dead end, Majlesi Allay, 2Apadana Ave,
City
Isfahan
Province
Isfehan
Postal code
8166763631
Phone
+98 31 3630 3512
Fax
Email
E.Hajeforoush@khuisf.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Elahe Hajeforoush
Position
PHD student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No.4 Aseman Flat, Harandizade Dead end, Majlesi Allay, 2Apadana Ave,
City
Isfahan
Province
Isfehan
Postal code
8166763631
Phone
+98 31 3630 3512
Fax
Email
E.Hajeforoush@khuisf.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available