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Protocol summary
ADHD scale using ADHD rating scale or Conner’s parent rating scale
ADHD scale using Conner’s parent rating scale.
Integrated Visual and Auditory Continues Performance Test (IVA/CPT)
ADHD scale using ADHD rating scale or Conner’s parent rating scale. Integrated Visual and Auditory Continues Performance Test (IVA/CPT)
اسکور ADHD با استفاده از پرسشنامه های ADHD rating scale یا Conner’s parent rating scale
اسکور ADHD با استفاده از پرسشنامه Conner’s parent rating scale .
آزمون عملکرد پیوسته دیداری و شنیداری (IVA/CPT).
اسکور ADHD با استفاده از پرسشنامه های ADHD rating scale یا Conner’s parent rating scale . آزمون عملکرد پیوسته دیداری و شنیداری (IVA/CPT).
General information
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As the industrial phase of the study took about two years, at the time of trial registration in IRCT, we wrote that we will use either Conner`s parent rating scale or ADHD rating scale as the primary outcome in clinical phase. After completing the industrial phase, it was decided to use the Conner`s parent rating scale (CPRS). So, we updated this part
As the industrial phase of the study took about two years, at the time of trial registration in IRCT, we wrote that we will use either Conner`s parent rating scale or ADHD rating scale as the primary outcome in clinical phase. After completing the industrial phase, it was decided to use the Conner`s parent rating scale (CPRS). So, we updated this part
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از انجاییکه فاز صنعتی و ساخت محصول پروبیوتیک حدود دوسال زمان میبرد، درزمان ثبت اولیه در سامانه کارازمایی بالینی، در قسمت پیامد اولیه نوشته شده بود که در فاز بالینی، یا از پرسشنامه کانرز یا از ADHD Rating Scale استفاده خواهد شد. پس از ساخت محصول مقرر شد از پرسشنامه کانرز جهت سنجش استفاده شود. لذا این قسمت بروز رسانی شد.
از انجاییکه فاز صنعتی و ساخت محصول پروبیوتیک حدود دوسال زمان میبرد، درزمان ثبت اولیه در سامانه کارازمایی بالینی، در قسمت پیامد اولیه نوشته شده بود که در فاز بالینی، یا از پرسشنامه کانرز یا از ADHD Rating Scale استفاده خواهد شد. پس از ساخت محصول مقرر شد از پرسشنامه کانرز جهت سنجش استفاده شود. لذا این قسمت بروز رسانی شد.
4-16 year old children
new case of ADHD diagnosed by psychiatrist
4-16 year old children
New case of ADHD diagnosed by psychiatrist
4-16 year old children newNew case of ADHD diagnosed by psychiatrist
history of treatment because of ADHD in the last 2 months
History of treatment because of ADHD in the last 2 months
Other psychological problems
Mental Retardation
historyHistory of treatment because of ADHD in the last 2 months Other psychological problems Mental Retardation
سابقه درمان دارویی به دلیل بیش فعالی طی دو ماه اخیر
سابقه درمان دارویی به دلیل بیش فعالی طی دو ماه اخیر
سایر اختلالات روانپزشکی
عقب ماندگی ذهنی
سابقه درمان دارویی به دلیل بیش فعالی طی دو ماه اخیر سایر اختلالات روانپزشکی عقب ماندگی ذهنی
Primary outcomes
#1
evaluation of ADHD scale with specific questionnaires like ADHD rating scale or Conner’s parent rating scale
evaluation of ADHD scale with Conner’s parent rating scale
evaluation of ADHD scale with specific questionnaires like ADHD rating scale or Conner’s parent rating scale
بررسی ADHD scale با استفاده از پرسشنامه هایی همانند ADHD rating scale یا Conner’s parent rating scale
بررسی ADHD scale با استفاده از پرسشنامه Conner’s parent rating scale
بررسی ADHD scale با استفاده از پرسشنامه هایی همانند ADHD rating scale یا Conner’s parent rating scale
Integrated Visual and Auditory Continues Performance Test (IVA/CPT)
Integrated Visual and Auditory Continues Performance Test (IVA/CPT)
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آزمون عملکرد پیوسته دیداری و شنیداری
آزمون عملکرد پیوسته دیداری و شنیداری
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Baseline and after 8 weeks
Baseline and after 8 weeks
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در ابتدای مطالعه و پس از 8 هفته
در ابتدای مطالعه و پس از 8 هفته
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A computerized standardized test consists of both auditory and visual parts
A computerized standardized test consists of both auditory and visual parts
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آزمون استاندارد کامپیوتری شامل بخشهای دیداری و شنیداری
آزمون استاندارد کامپیوتری شامل بخشهای دیداری و شنیداری
Protocol summary
Study aim
to evaluate the effect of probiotic in the treatment of ADHD children
Design
Triple blind parallel randomized controlled trial
intervention group: ADHD treatment + probiotic
control group: ADHD treatment + placebo
n= 30 patients in each group
Settings and conduct
4-16 year old ADHD patients who are referred to Ibn-e-Sina psychiatric clinic enter to this study(after their parents sign the informed consent form). Patients randomly divide to 2 groups: intervention(ADHD treatment + probiotic) and control(ADHD treatment + placebo). All patients, assessors and analyzer are blind(more description about blinding is presented in the specific part for blinding)
Participants/Inclusion and exclusion criteria
4-16 year old children with ADHD, without any treatment in the last 2 months
ADHD scale using Conner’s parent rating scale.
Integrated Visual and Auditory Continues Performance Test (IVA/CPT)
General information
Reason for update
As the industrial phase of the study took about two years, at the time of trial registration in IRCT, we wrote that we will use either Conner`s parent rating scale or ADHD rating scale as the primary outcome in clinical phase. After completing the industrial phase, it was decided to use the Conner`s parent rating scale (CPRS). So, we updated this part
Acronym
IRCT registration information
IRCT registration number:IRCT20181022041407N1
Registration date:2018-11-02, 1397/08/11
Registration timing:prospective
Last update:2023-05-20, 1402/02/30
Update count:1
Registration date
2018-11-02, 1397/08/11
Registrant information
Name
Maryam Emadzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3882 9262
Email address
emadzadehm@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-20, 1399/01/01
Expected recruitment end date
2020-10-22, 1399/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of probiotic on the treatment of ADHD children
Public title
evaluation the effect of probiotic on treatment of ADHD children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
4-16 year old children
New case of ADHD diagnosed by psychiatrist
Exclusion criteria:
History of treatment because of ADHD in the last 2 months
Other psychological problems
Mental Retardation
Age
From 4 years old to 16 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple Randomization
Randomization Method: excel software or other randomization websites
Allocation Concealment: opaque envelope
Blinding (investigator's opinion)
Triple blinded
Blinding description
After the description about the method and aim of the study and informed consents of parents, randomization will be done. The type of treatment is written with odds and even number in separate papers and placed in an opaque envelope. After the psychiatrist visits the patients, if the patients have the inclusion criteria, the method of the study will describe to the parents. If they agree to participate in this study, the informed consent form must be completed. Then the psychiatrist will take an envelope and write the patients characteristic with the special number(odds or even) in the list. So, patients and psychiatrist only know the number (not the intervention or control group). After the special time, the assessor evaluates the children with the specific questionnaire. He does not know which group the patient is (blind). Then the complete data will b presented to the analyzer for data analysis. In the datasheet the group will type as odd/even numbers(not the group names), so the analyzer is blind too.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Institutional Research Ethics Committee, School of Medicine- Mashhad University of Medical Sciences
Street address
Azadi Square, University Campus, Faculty of Medicine
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Approval date
2018-09-05, 1397/06/14
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1397.030
Health conditions studied
1
Description of health condition studied
ADHD
ICD-10 code
F90.9
ICD-10 code description
Attention-deficit hyperactivity disorder, unspecified type
Primary outcomes
1
Description
evaluation of ADHD scale with Conner’s parent rating scale
Timepoint
Baseline, 4 and 8 weeks after the first visit
Method of measurement
Conner’s parent rating scale
Secondary outcomes
1
Description
Integrated Visual and Auditory Continues Performance Test (IVA/CPT)
Timepoint
Baseline and after 8 weeks
Method of measurement
A computerized standardized test consists of both auditory and visual parts
Intervention groups
1
Description
Intervention group: ADHD treatment + probiotic
Category
Treatment - Drugs
2
Description
Control group: ADHD treatment + placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ibn-e-Sina Hospital, Psychiatric Clinic
Full name of responsible person
Maryam Emadzadeh
Street address
Ibn-e-Sina Hospital, Hor-e-Ameli Street
City
Mashhad
Province
Razavi Khorasan
Postal code
919583134
Phone
+98 51 3711 2701
Email
maryamemadzadeh@yahoo.com
Web page address
http://sina.mums.ac.ir/index.php
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Ghoreyshi Building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Phone
+98 51 3841 2081
Fax
+98 51 3841 3006
Email
presidentoffice@mums.ac.ir
Web page address
http://www.mums.ac.ir/
Grant name
Mashhad University of Medical Sciences
Grant code / Reference number
961476
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
80
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
2
Sponsor
Name of organization / entity
Research Institute of Food Science and Technology
Full name of responsible person
Mahdi Ziaratnia
Street address
km. 12- Mashhad/ Quchan Highway
City
Mashhad
Province
Razavi Khorasan
Postal code
9185176933
Phone
+98 51 3542 5421
Fax
+98 51 3542 5406
Email
info@rifst.ac.ir
Web page address
https://www.rifst.ac.ir/
Grant name
Research grant of Research Institute of Food Science and Technology
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Institute of Food Science and Technology
Proportion provided by this source
20
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
Mashhad University of Medical Sciences
Full name of responsible person
Maryam Emadzadeh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Public Health/Community Medicine
Street address
Department of Community Medicine, Faculty of Medicine, University Campus, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3882 9262
Email
maryamemadzadeh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Maryam Emadzadeh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Public Health/Community Medicine
Street address
Department of Community Medicine, Faculty of Medicine, University Campus, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3882 9262
Email
maryamemadzadeh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Maryam Emadzadeh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Public Health/Community Medicine
Street address
Department of Community Medicine, Faculty of Medicine, University Campus, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3882 9262
Email
maryamemadzadeh@yahoo.com
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
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available