Comparison of the Effectiveness of Pharmacotherapy and Neurofeedback on Improving Executive Functions and Externalizing Behavior Disorders in children with attention deficit-hyperactivity disorder
The aim of this study is to Comparison of the Effectiveness of Pharmacotherapy and Neurofeedback on Improving Executive Functions and Externalizing Behavior Disorders in children with attention deficit-hyperactivity disorder
Design
Clinical trial with control group, were conducted with double-blind, randomized parallel groups on 36 patients and sealed envelope was used for randomization.
Settings and conduct
Experimental half method in which random clinical trial project with active control group (Pre-test Post-test) will have been used. The place of experiment will be the psychological clinic.
Participants/Inclusion and exclusion criteria
Inclusion/Exclusion criteria are receiving informed consent, gender (boy), age range (8 to 12 years), Average IQ (90 to 109), definitive diagnosis of attention deficit hyperactivity disorder, obtaining the necessary cut score in the scales for all three groups
Intervention groups
The two experimental groups included a drug therapy group that will receive methylphenidate twice daily in the morning and evening for 10 weeks (starting at 5 mg and increasing to 10 mg within one week by the end of the intervention period) and the neurofeedback intervention group, in which subjects will receive neurofeedback 3 times a week (for 10 weeks) in 30 sessions of 45 minutes. The control group will be on the waiting list and will not receive any treatment.
Main outcome variables
Executive Function and Externalizing Behavior Disorders
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161122031016N2
Registration date:2022-08-30, 1401/06/08
Registration timing:retrospective
Last update:2022-08-30, 1401/06/08
Update count:0
Registration date
2022-08-30, 1401/06/08
Registrant information
Name
Bahman akbari
Name of organization / entity
Islamic Azad University of Rasht Branch
Country
Iran (Islamic Republic of)
Phone
+98 13 3342 4081
Email address
akbari@iaurasht.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-09, 1400/11/20
Expected recruitment end date
2022-03-16, 1400/12/25
Actual recruitment start date
2022-04-06, 1401/01/17
Actual recruitment end date
2022-05-23, 1401/03/02
Trial completion date
2022-05-23, 1401/03/02
Scientific title
Comparison of the Effectiveness of Pharmacotherapy and Neurofeedback on Improving Executive Functions and Externalizing Behavior Disorders in children with attention deficit-hyperactivity disorder
Public title
Psychological interventions and Pharmacotherapy on improving the condition of children with attention deficit-hyperactivity disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Receiving written consent from parents and informed consent of the child
gender (boy)
age range (8 to 12 years)
Average IQ (90 to 109) based on the Wechsler IQ test that is recorded in the child's file and clinical observations recorded by experts
definitive diagnosis of Attention Deficit Hyperactivity Disorder based on the criteria of the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders by a pediatric psychiatrist and child and adolescent clinical psychologist
obtaining the necessary cut score in the Behavior Rating Inventory of Executive Function (BRIEF), Gerard et al. (2000), and Achenbach's Child Behavior Checklist (CBCL), Achenbach (2001) for all three groups (two experimental groups and one control group)
Exclusion criteria:
Suffering from neurological-developmental or other psychological disorders at the same time
receiving other medical and psychological interventions at the same time
Age
From 8 years old to 12 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
45
Actual sample size reached:
36
Randomization (investigator's opinion)
Randomized
Randomization description
The limited block randomization method was used for randomization. In order to determine the 2 experimental and 1 control groups, 15 balls with code A for the experimental group 1, 15 balls with code B for the experimental group 2, and 15 balls with code C for the control group were considered. They will then be placed inside the lottery container and, without replacement, the balls will be randomly removed from the container and the sequence created will be recorded. Next, based on the research sample size, a number of aluminum envelopes are prepared and each random sequence is recorded on a card and the cards are placed in the envelopes in order.
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 Islamic Azad University of Rasht
Street address
Darvazeh Lakan Street, Gas Square
City
Rasht
Province
Guilan
Postal code
۴۱۴۷۶۵۴۹۱۹
Approval date
2022-01-26, 1400/11/06
Ethics committee reference number
IR. IAU. RASHT. REC. 1400. 036
Health conditions studied
1
Description of health condition studied
Attention deficit_ hyperactivity disorder
ICD-10 code
F90.2
ICD-10 code description
Attention-deficit hyperactivity disorder, combined type
Primary outcomes
1
Description
Executive Functions
Timepoint
Before the start of the intervention, after the end of the intervention, Two month after the end of the intervention
Method of measurement
Behavior Rating Inventory of Executive Function (BRIEF)
2
Description
Externalizing Behavior Disorders
Timepoint
Before the start of the intervention, after the end of the intervention, Two month after the end of the intervention
Method of measurement
Achenbach's Child Behavior Checklist (CBCL)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Methylphenidate was started twice daily in the morning and evening for 5 weeks at a dose of 5 mg and increased to 10 mg twice daily for one week until the end of the intervention period.
Category
Treatment - Drugs
2
Description
Intervention group: Neurofeedback, 30 sessions for 10 weeks (three times a week, each session 45 minutes)
Category
Treatment - Devices
3
Description
Control group: Without intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Khazaeli Special School
Full name of responsible person
Parvaneh Seyedi
Street address
Fajr Town, Azadegan Street
City
Rasht
Province
Guilan
Postal code
4189845353
Phone
+98 13 3381 0081
Fax
+98 13 3381 0081
Email
support@schpedia.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University, Rasht Branch
Full name of responsible person
Alireza Seidavi
Street address
Darvazeh Lakan Street, Gas Square
City
رشت
Province
Guilan
Postal code
4147654919
Phone
+98 13 3342 4080
Fax
+98 13 3344 7060
Email
alirezaseidavi@iaurasht.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Islamic Azad University, Rasht Branch
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, Rasht Branch
Full name of responsible person
Fatemeh Hedayati Shalkouhi
Position
PhD Candidate in Psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Darvazeh Lakan Street, Gas Square
City
رشت
Province
Guilan
Postal code
۴۱۴۷۶۵۴۹۱۹
Phone
+98 13 3347 2099
Email
Fahim_hedayati@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University, Rasht Branch
Full name of responsible person
Bahman Akbari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Darvazeh Lakan Street, Gas Square
City
رشت
Province
Guilan
Postal code
۴۱۴۷۶۵۴۹۱۹
Phone
+98 13 3347 2099
Email
bAkbari44@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University, Rasht Branch
Full name of responsible person
Bahman Akbari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Darvazeh Lakan Street, Gas Square
City
رشت
Province
Guilan
Postal code
۴۱۴۷۶۵۴۹۱۹
Phone
+98 13 3347 2099
Email
bAkbari44@yahoo.com
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
There is no more information
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
There is no more information
When the data will become available and for how long
There is no more information
To whom data/document is available
There is no more information
Under which criteria data/document could be used
There is no more information
From where data/document is obtainable
There is no more information
What processes are involved for a request to access data/document