Protocol summary

Study aim
The Comparison of the Effectiveness of Cognitive Rehabilitation and Cognitive Rehabilitation after Pharmacology on Brain Executive Functions in Children with ADHD Disorder in Ahwaz
Design
The cluster sampling method was a research in the two groups of cognitive rehabilitation intervention and cognitive rehabilitation group after drug therapy (parallel). They were compared with the control group.
Settings and conduct
This research was carried out in schools and educational counseling center of Ahvaz district 3.
Participants/Inclusion and exclusion criteria
Having an ADHD disorder with counseling and psychiatrist diagnosis.
Intervention groups
A group that is diagnosed with cognitive rehabilitation after the diagnosis of a disorder. A group that includes cognitive rehabilitation program after counseling, referral to a psychiatrist, and drug use.
Main outcome variables
The main consequence of this intervention was the positive effects of cognitive rehabilitation combined with drug use.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181107041591N1
Registration date: 2019-02-26, 1397/12/07
Registration timing: retrospective

Last update: 2019-02-26, 1397/12/07
Update count: 0
Registration date
2019-02-26, 1397/12/07
Registrant information
Name
seyedhamidreza seyedmohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3551 3731
Email address
boxinghamid@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-10-12, 1396/07/20
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
2017-10-12, 1396/07/20
Actual recruitment end date
2018-04-16, 1397/01/27
Trial completion date
2018-05-05, 1397/02/15
Scientific title
Comparison of the effectiveness of cognitive rehabilitation and cognitive rehabilitation after medication on the brain functions of children with ADHD in Ahvaz
Public title
Comparison of the Effectiveness of Cognitive Rehabilitation and Cognitive Rehabilitation after Drug Therapy on Brain Executive Functions
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Students identified as having an ADHD disorder as a consultant and researcher. Students who were referred to psychiatrists for examination and prescription after being diagnosed as counselors and psychologists.
Exclusion criteria:
Children who were collectively under the medication and rehabilitation program. Children who did not have the ability to answer questionnaire questions.
Age
From 9 years old to 12 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 45
Actual sample size reached: 45
Randomization (investigator's opinion)
Randomized
Randomization description
Sample groups were selected using multistage cluster random sampling. First, from the four education districts of Ahvaz city, in the draw, district 3 was selected and from all elementary school students of that area, among all children who were diagnosed with hyperactivity / lack of attention during the first trimester of the semester The first academic year from 97 to 96 years old was referred to Ahvaz 3rd District Consultation and Psychological Services Center (consultation core); the Conners questionnaire was implemented, and among all of these people with the diagnosis of ADHD, 45 persons were selected. 15 of them randomly entered the cognitive rehabilitation program, and 15 of the children who received medication for at least three months were assigned to the cognitive rehabilitation group after medication. 15 patients were considered as control group.
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 AHVAZ University of Medical Sciences
Street address
Ahvaz. Farhangshahr. Kargar gharbi
City
Ahvaz
Province
Khouzestan
Postal code
6183873169
Approval date
2019-01-02, 1397/10/12
Ethics committee reference number
IR.IAU.AHVAZ.REC.1397.008

Health conditions studied

1

Description of health condition studied
Adhd disorder
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
ADHD
Timepoint
Before and after the implementation of the rehabilitation and rehabilitation program after drug therapy and 1.5 months after the last session of the follow-up session.
Method of measurement
Straightforward cropping test questionnaire, B and C tracking test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Under the cognitive rehab program, students are trained and tested using the Cortex Rehabilitation Package and in 12 rehabilitation sessions.
Category
Rehabilitation

2

Description
A group of about 3 months of diagnosis of ADHD disorder by the past psychiatrist who was taking the medication and who was treated with cognitive rehabilitation after having undergone treatment.
Category
Treatment - Drugs

3

Description
Control group: Control group: No treatment program.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Ahvaz schools and counseling center
Full name of responsible person
Alireza Sheikh Najdi
Street address
Corner of the street is Kafi, Abadan Four ways
City
AHVAZ
Province
Khouzestan
Postal code
6183873175
Phone
+98 61 3553 1007
Email
BOXINGHAMID@GMAIL.COM

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University of Ahvaz
Full name of responsible person
Dr. Behnam Makvandi
Street address
No.7, 7th St., Padad shahr
City
Ahvaz
Province
Khouzestan
Postal code
6183873169
Phone
+98 61 3551 3731
Email
MAKVANDI_B@yahoo.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 of Ahvaz
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
Islamic Azad University of Ahvaz
Full name of responsible person
Seyed Hamid Reza Seyed Mohammadi
Position
Education employee
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No.7, 7th St., Padad shahr
City
AHVAZ
Province
Khouzestan
Postal code
6183873169
Phone
+98 61 3551 3731
Email
BOXINGHAMID@GMAIL.COM

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University of Ahvaz
Full name of responsible person
seyed Hamid Reza Seyed Mohammadi
Position
Employee
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No.7, 7th St., Padad shahr
City
Ahvaz
Province
Khouzestan
Postal code
6183873175
Phone
+98 61 3551 3731
Email
boxinghamid@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University of Ahvaz
Full name of responsible person
Seyed Hamid Reza Seyed Mohammadi
Position
Employee
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No.7, 7th St., Padad shahr
City
ahvaz
Province
Khouzestan
Postal code
6183873169
Phone
+98 61 3551 3731
Email
boxinghamid@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All information will be given.
When the data will become available and for how long
I do not have access to the results 6 months after printing and other conditions.
To whom data/document is available
All interested and specialist
Under which criteria data/document could be used
I do not have access to the results 6 months after printing and other conditions.
From where data/document is obtainable
Refer to myself and my email
What processes are involved for a request to access data/document
boxinghamid@gmail.com 09165090269 Get started 6 months after printing results.
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