Protocol summary

Study aim
Assessing the effectiveness of Yang Thinking and Reasoning Skills Training Package and compare its effectiveness with Pars Empowerment Training Package on selective attention problems.
Design
45 children were selected by the available sampling method. Then the subjects were divided into three groups of 15 people, two experimental groups and one control group (using a table of random numbers) using a simple random method. Without blinding.
Settings and conduct
45 students referred to the specialized occupational therapy clinic related to the welfare of Isfahan province. After screening and randomly assigning subjects into two training groups and a control group, the training group with Yang's thinking and reasoning skills method during 8 60-minute sessions using Yang's thinking and reasoning skills training package and the training group with Pars cognitive package in During 12 sessions oion of social competence), all the people of the 3 groups (two experimental groups and the control group) will be measured as a post-test. To ensure the effectiveness of the approaches of each Two training packages were measured once again in a period of 1 month after the intervention.
Participants/Inclusion and exclusion criteria
The criteria for entering people include the presence of mixed attention deficit hyperactivity disorder, completion of the satisfactory form, being in the range of 9 to 12 years, and the Connors score being higher than the cut-off point. Exclusion criteria include the presence of concomitant psychiatric disorders and the use of a regular medication regimen
Intervention groups
Intervention group 1: Yang's thinking and reasoning skills training package. Intervention group 2: Pars empowerment training package. Control group: regular training
Main outcome variables
symptoms of hyperactivity

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220604055075N1
Registration date: 2022-12-19, 1401/09/28
Registration timing: retrospective

Last update: 2022-12-19, 1401/09/28
Update count: 0
Registration date
2022-12-19, 1401/09/28
Registrant information
Name
meead saifipour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 4527 8048
Email address
miad.saifipour@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-30, 1399/08/09
Expected recruitment end date
2021-02-22, 1399/12/04
Actual recruitment start date
2021-02-02, 1399/11/14
Actual recruitment end date
2021-02-22, 1399/12/04
Trial completion date
empty
Scientific title
Validation of Young's Thinking and Argumentation Skills Curriculum Package and Comparing Its Effectiveness with the Pars's Power-Generating Educational Package on the Problems and Selective Attention , Mood Instability ,Impulsivity , Social Competence Perception in Children Aged 8-12 Years Old Attention Deficit - Hyperactivity in the Primary School
Public title
Validation of Young thinking and reasoning skills training package and comparison of its effectiveness with Pars empowerment training package on selective attention problems, mood instability, impulsivity, perception of social competence and symptoms of ADHD
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
The candidate's complete agreement to engage in the study Age range 8 to 12 years Not being participated in other treatment programs at the same time and obtaining individual counseling and medication Existence of accompanying psychiatric disorders Use a regular medication regimen Diagnosing Attention Deficit Hyperactivity Disorder combined sub-type by psychiatrists according to the Diagnostic and Statistical Manual of Mental Disorders
Exclusion criteria:
Existing comorbid psychiatric disorders such as autism spectrum disorder, learning disorders, and so on. regular use of medication except for Methylphenidate
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: 45
Actual sample size reached: 15
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization with statistical software through the website https://www.Randomization.com was used online for random allocation. The output of that were numbers.The first 15 numbers were assigned to the first test group, the second 15 numbers to the second test group, and the third 15 numbers to the control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The study has been approved by the ethics committee of the Islamic Azad University, Khorasgan branch. Code of EthicsIR.IAU.KHUISF.REC.1398.290

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University, Khorasgan Branch
Street address
Isfahan, East Jay Street, Arghavanieh, University Boulevard
City
Esfahan
Province
Isfehan
Postal code
۸۱۵۵۱-۳۹۹۹۸
Approval date
2020-01-26, 1398/11/06
Ethics committee reference number
IR.IAU.KHUISF.REC.1398.290

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
Perception of social competence
Timepoint
Before the intervention and the following week and three months after the intervention
Method of measurement
Social Competence Perception Questionnaire

2

Description
Mood instability
Timepoint
Before the intervention and the following week and three months after the intervention
Method of measurement
Mood instability questionnaire

3

Description
Impulsivity
Timepoint
Before the intervention and the following week and three months after the intervention
Method of measurement
Bart's Impulse Scale

4

Description
Selective attention problems
Timepoint
Before the intervention and the following week and three months after the intervention
Method of measurement
Test word and color strops

5

Description
Symptoms of hyperactivity disorder
Timepoint
Before the intervention and the following week and three months after the intervention
Method of measurement
Attention Deficit Hyperactivity Disorder Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
The first intervention group: Yang's thinking and reasoning skills training package (8 sessions of 2 hours)
Category
Rehabilitation

2

Description
The second intervention group: Pars 8 empowerment training package, 2-hour session
Category
Rehabilitation

3

Description
Control group: Does not receive any intervention
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Schools of Isfahan District 6 Education
Full name of responsible person
Miad Saifipour
Street address
Shahinshahr, South Saadi Street, West 1, Baran Complex, Unit 3
City
Esfahan
Province
Isfehan
Postal code
۸۱۵۹۵-۱۵۸
Phone
+98 21 5573 5961
Email
Miad.saifipour@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Miad Seifipour
Street address
Shahinshahr, South Saadi Street, West 1, Baran Complex, Unit 3
City
Esfahan
Province
Isfehan
Postal code
۸۱۵۵۱-۳۹۹۹۸
Phone
+98 21 5573 5961
Email
miad.seifipour@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Islamic Azad University, Isfahan Branch, Khorasgan
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
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Miad Seifipour
Position
PhD student in General Psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Shahinshahr, South Saadi Street, West 1, Baran Complex, Unit 3
City
Esfahan
Province
Isfehan
Postal code
۸۱۵۵۱-۳۹۹۹۸
Phone
+98 21 5573 5961
Email
miad.seifipour@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Miad Seifipour
Position
PhD student in General Psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Shahinshahr, South Saadi Street, West 1, Baran Complex, Unit 3
City
Esfahan
Province
Isfehan
Postal code
۸۱۵۵۱-۳۹۹۹۸
Phone
+98 21 5573 5961
Email
miad.seifipour@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Miad Seifipour
Position
PhD student in General Psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Isfahan - East Jay St. - Purple - University Blvd.
City
Esfahan
Province
Isfehan
Postal code
۸۱۵۵۱-۳۹۹۹۸
Phone
+98 21 3373 5961
Email
maid.saifipour@gmail.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
No further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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