UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040182 |
|---|---|
| Receipt number | 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 03:35:45 |
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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 & Mohammad Bagher |
| Middle name | |
| Last name | Ghasem &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
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
m.b.kaj@edu.ui.ac.ir
Sponsor or person
Institute
Department of Psychology and Educational Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045818
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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