Protocol summary

Study aim
The purpose of this study was to investigate the effectiveness of computer-based cognitive training on visual / auditory working memory performance, sustained attention, and theory of mind in children with attention deficit hyperactivity disorder
Design
he present study was empirically based on a pretest-posttest design with a control group.
Settings and conduct
For 10 45-minute sessions (2 sessions per week), she was individually placed in Roshana Counseling Center.
Participants/Inclusion and exclusion criteria
30 male and female students with attention deficit / hyperactivity disorder in the age range of 8 to 11 years who were studying in schools in Tabriz in the academic year of 1397-98.
Intervention groups
Relying on targeted sampling method, 30 children with attention deficit / hyperactivity disorder were selected by observing Word and exit criteria and were replaced by random substitution method in experimental group (computer-based cognitive training) and control group (15 people in each group). . The intervention group participated in the treatment sessions but the control group did not receive any treatment.
Main outcome variables
attention deficit hyperactivity disorder

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200221046565N1
Registration date: 2020-04-22, 1399/02/03
Registration timing: retrospective

Last update: 2020-04-22, 1399/02/03
Update count: 0
Registration date
2020-04-22, 1399/02/03
Registrant information
Name
Raheleh Vahid
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3326 5986
Email address
azmodeh.m65@gmail.com‏
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-03, 1397/01/14
Expected recruitment end date
2018-05-10, 1397/02/20
Actual recruitment start date
2018-04-03, 1397/01/14
Actual recruitment end date
2018-05-10, 1397/02/20
Trial completion date
2018-10-07, 1397/07/15
Scientific title
Effectiveness of computer based cognitive progressive intervention on audio/visual working memory, sustained attention and theory of mind on children with attention deficit hyperactivity disorder
Public title
Computer Based Training of Progressive Cognition on audio/ visual working memory in children with Attention Deficit/ Hyperactivity Disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
A) having attention deficit / hyperactivity disorder. b) tendency to participate in the study. c) having moderate intelligence (90 and above) d) not being affected by other disorders
Exclusion criteria:
Dissatisfaction with studying Having a physical disability that prevents you from working with a computer. Taking stimulant medications and other disorders
Age
From 8 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Actual sample size reached: 30
Randomization (investigator's opinion)
Randomized
Randomization description
The selection of children was initially targeted by sampling. We then divided them into two groups of intervention and control in a simple random way based on a table of random numbers.
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
Tabriz Faculty of Medicine
Street address
Department of Psychology, Tabriz Branch, Islamic Azad University, Tabriz, Iran.
City
tabriz
Province
East Azarbaijan
Postal code
5157944533
Approval date
2019-09-04, 1398/06/13
Ethics committee reference number
IR.IAU.TABRIZ.REC.1398.050

Health conditions studied

1

Description of health condition studied
children with attention deficit hyperactivity disorder
ICD-10 code
F90
ICD-10 code description
Attention-deficit hyperactivity disorders

Primary outcomes

1

Description
Attention Deficit/ Hyperactivity Disorder
Timepoint
audio/visual working memory, sustained attention and theory of mind
Method of measurement
Clinical interview, child morbidity questionnaire, CPT test, Wechsler memory test, and theory of mind test

Secondary outcomes

empty

Intervention groups

1

Description
The experimental group underwent active memory improvement software test and my mind software software for 10 45-minute sessions (2 sessions per week) were individually placed in Roshana Counseling Center.
Category
Treatment - Other

2

Description
Control group:The control group did not receive treatment.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Roshana Counseling Center
Full name of responsible person
Raheleh Vahid
Street address
Department of Psychology, Tabriz Branch, Islamic Azad University, Tabriz, Iran.
City
Tabriz
Province
East Azarbaijan
Postal code
5157944533
Phone
+98 41 3328 0603
Email
R_vahidi_91@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hasan Rasooli saghai
Street address
Department of Psychology, Tabriz Branch, Islamic Azad University, Tabriz, Iran.
City
tabriz
Province
East Azarbaijan
Postal code
5157944533
Phone
+98 41 3328 0603
Email
R_vahidi_91@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
personal
Proportion provided by this source
1
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
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Masumeh Azemodeh
Position
Department of Psychology, Tabriz Branch, Islamic Azad University, Tabriz, Iran.
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Department of Psychology, Tabriz Branch, Islamic Azad University, Tabriz, Iran.
City
Tabriz
Province
East Azarbaijan
Postal code
5157944533
Phone
004131966498
Email
Mas_Azemodeh@iaut.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Raheleh Vahid
Position
PhD candidate of Psychology, Tabriz Branch, Islamic Azad University, Tabriz, Iran.
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Department of Psychology, Tabriz Branch, Islamic Azad University, Tabriz, Iran.
City
tabriz
Province
East Azarbaijan
Postal code
5157944533
Phone
+98 41 3328 0603
Email
R_vahidi_91@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Raheleh Vahid
Position
PhD candidate of Psychology, Tabriz Branch, Islamic Azad University, Tabriz, Iran.
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Department of Psychology, Tabriz Branch, Islamic Azad University, Tabriz, Iran.
City
Tabriz
Province
East Azarbaijan
Postal code
5157944533
Phone
+98 41 3328 0603
Email
R_vahidi_91@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
The data will be confidentially archived by the researcher and only their results will be reported.
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The collected data were analyzed using SPSS-22 software
When the data will become available and for how long
The data will be confidentially archived by the researcher and only their results will be reported.
To whom data/document is available
Researcher
Under which criteria data/document could be used
In order to report data and research results and help treat attention deficit hyperactivity disorder
From where data/document is obtainable
-
What processes are involved for a request to access data/document
-
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