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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040182
Receipt No. R000045818
Scientific Title Educational Package on Symptoms of Children with Attention Deficit / Hyperactivity Disorder.
Date of disclosure of the study information 2020/04/17
Last modified on 2020/04/17

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Basic information
Public title The Effectiveness of the Dawson and Goyer Educational Package on Symptoms of Children with Attention Deficit / Hyperactivity Disorder.
Acronym The Effectiveness of the Dawson and Goyer Educational Package on ADHD
Scientific Title Educational Package on Symptoms of Children with Attention Deficit / Hyperactivity Disorder.
Scientific Title:Acronym the Dawson and Goyer Educational Package /ADHD
Region
Asia(except Japan)

Condition
Condition in children 7 to 13 years of Attention Deficit / Hyperactivity Disorder
Classification by specialty
Psychosomatic Internal Medicine Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The Effectiveness of the Dawson and Goyer Educational Package on Symptoms of Children with Attention Deficit / Hyperactivity Disorder.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase I

Assessment
Primary outcomes Dawson and Goyer Educational Package is effective in reduc Symptoms of Children with Attention Deficit / Hyperactivity Disorder.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 5
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom Other
Interventions/Control_1 Pre-test Children with Attention Deficit / Hyperactivity Disorderwill first be taken.
Interventions/Control_2 The Children with Attention Deficit / Hyperactivity Disorder. in the study were divided into control and experimental groups.
Interventions/Control_3 The intervention is performed on the experimental group and the control group does not receive any treatment.
Interventions/Control_4 The intervention protocol utilizes Dawson and Goyer Educational Package
Interventions/Control_5 Running time will be eleven hour and a halfsessions in group, once a week.
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
7 years-old <=
Age-upper limit
13 years-old >=
Gender Male and Female
Key inclusion criteria Diagnosis of ADHD is based on a DSM-V classification in a primary school child (which has been confirmed by a clinical psychologist, parental willingness, the child's willingness to participate in a research project, non-use of concurrent psychological and pharmacological therapies).
Key exclusion criteria Lack of cooperation, failure to perform the tasks presented in the meetings, absence of more than 2 sessions, cancellation of the research
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Khalil i &amp; Mohammad Bagher
Middle name
Last name Ghasem &amp;Kajbaf
Organization Khorasgan Azad Universit
Division name Faculty of Humanities
Zip code 81551-39998
Address Islamic Azad University, Isfahan Branch (Khorasgan), Khorasgan, Isfahan, Iran.
TEL 00989365553976
Email natanael.752001@gmail.com

Public contact
Name of contact person
1st name Mohammad Bagher
Middle name
Last name Kajbaf
Organization University Esfahan
Division name Researcher & University professor
Zip code 8155139998
Address University blvd . Purple. East Jay Street. Esfahan
TEL 00989365553976
Homepage URL
Email m.b.kaj@edu.ui.ac.ir

Sponsor
Institute Department of Psychology and Educational Sciences
Institute
Department

Funding Source
Organization University professor and researcher
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Iran

Other related organizations
Co-sponsor Kajbaf Mohammad Bagher
Name of secondary funder(s)

IRB Contact (For public release)
Organization University khorasghan
Address University blvd . Purple. East Jay Street. Esfahan
Tel 00983135354001
Email info@khuisf.ac.ir

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2020 Year 04 Month 17 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2020 Year 03 Month 15 Day
Date of IRB
Anticipated trial start date
2020 Year 05 Month 01 Day
Last follow-up date
2020 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 04 Month 17 Day
Last modified on
2020 Year 04 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045818

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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