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The educational intervention based on a planned behavioral theory on promoting healthy behaviors associated with AIDS on labor children in Zahedan city in 2018

Protocol summary

Study aim
Determine the effect of The educational intervention based on a planned behavioral theory on promoting health behaviors associated with AIDS on labor children
Design
the clinical trial has control and intervention groups. Considering the fact that the total number for inclusion in the study is 200 persons, 100persons will be included in the intervention and 100persons in the control group .
Settings and conduct
Primary Information in the intervention and control group in child labor center through questionnaires and self-completion or interview with the help of the interviewers or self-researcher are completed and entered into the computer and analyzed using SPSS software.Then based on the findings, the curriculum includes the content of education, goals and educational media based on the needs of the participants in the research.Then, educational intervention was performed for the intervention group and after the waiting period, the information was recaptured and analyzed using descriptive statistics and descriptive statistics.
Participants/Inclusion and exclusion criteria
criteria for entering: satisfaction to participate in the study, the age of 5-15 years for girls and 6 to 18 years for boys,exit criteria:the reluctance to continue cooperation and participation in educational intervention or lack of ability to provide appropriate responses.Questions as well as those who change their place of residence during intervention.
Intervention groups
individual and group training, including Q & A sessions, discussions, classroom training, and presentation of a booklet are on the agenda.
Main outcome variables
Change consciousness,Chang attetude,Moral norms,Mental norms,Perceived behavioral control,Perceived self-awareness,Perceived behavioral intent.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180904040951N1
Registration date: 2018-11-14, 1397/08/23
Registration timing: prospective

Last update: 2018-11-14, 1397/08/23
Update count: 0
Registration date
2018-11-14, 1397/08/23
Registrant information
Name
Raziyeh sadat Abolhasani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3252 2706
Email address
abolhasani73@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-22, 1397/09/01
Expected recruitment end date
2019-03-19, 1397/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The educational intervention based on a planned behavioral theory on promoting healthy behaviors associated with AIDS on labor children in Zahedan city in 2018
Public title
The planned educational intervention on promoting healthy behaviors associated with AIDS on labor children
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
consent to participating in the study age range of 5-15 years for girls and 6 to 18 years for boys.
Exclusion criteria:
Not having the ability to respond appropriately to questions Unwillingness to continue to cooperate and participate in educational intervention People who change their place of residence during an educational intervention.
Age
From 5 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 200
Randomization (investigator's opinion)
Randomized
Randomization description
Stratified Random Sampling The total number of eligible children in the study is 200, 100 of them are in the intervention group and 100 in the control group will be included in the study. First, according to the conditions of the subjects, they are divided into two groups according to sex. Then according to the age groups, the individuals are classified into three age groups and the individuals are randomly assigned to each group based on the percentage of the class relative to the total number of individuals.
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 zahedan University of Medical Sciences
Street address
Unvercity of Medical Sciences.Dr Hesabi Sq.Zahedan
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2018-10-07, 1397/07/15
Ethics committee reference number
ir.zaums.rec.1397.286

Health conditions studied

1

Description of health condition studied
AIDS
ICD-10 code
Z21
ICD-10 code description
Asymptomatic human immunodeficiency virus [HIV] infection status

Primary outcomes

1

Description
Promoting healthy child labor behaviors
Timepoint
At the beginning of the study and two months later
Method of measurement
Questionnaire

Secondary outcomes

1

Description
Child labor awareness rate
Timepoint
At the beginning of the study and two months after the intervention
Method of measurement
questionnare

Intervention groups

1

Description
In the first stage, the preliminary information (before the intervention) was completed through a questionnaire and by self-completion or interview with the help of the interviewer or the researcher.Then based on the findings,the training program, including educational content, goals and educational media, is designed, based on the needs of the collaborators involved in the research.In addition, both intervention and control groups benefit from routine state welfare organization training classes. "Intervention group:"The educational intervention designed to promote healthy behaviors is implemented for the "intervention group" and After the waiting period (at least two months), the information is recaptured and analyzed using descriptive statistics and statistics test.
Category
Behavior

2

Description
Control group: "Control group:" There will not be any training intervention for this group, but this group will be done with the same time Post test and the information will be re-collected.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
koosha Child Labor
Full name of responsible person
Makkeh Shahnavazi
Street address
Keshavarz 6,Keshavarz Boulevard
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9813966345
Phone
+98 54 3331 7095
Email
a.makhdoomid73@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ahmad Mehraban
Street address
Faculty of Medical Sciences,Zahedan Branch, Islamic azad university , zahedan , Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
98138-987
Phone
+98 54 3113 5582
Email
ahmadmh2004@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
Proportion provided by this source
100
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
Other

Person responsible for general inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Gholamreza Masoudy
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Unvercity of Medical Sciences, Dr. Hesabi. Sq, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3343 8818
Email
Masoudy55@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Javid Dehghan Haghighi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Public Health/Community Medicine
Street address
Unvercity of Medical Sciences, Dr Hesabi. Sq, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5825
Email
javid_dehghan@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Raziyeh sadat Abolhasani
Position
Intern
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Faculty of Medical Sciences, zahedan Branch, Islamic azad university
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
98138-987
Phone
+98 54 3113 5582
Email
abolhasani73@yahoo.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 more information
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
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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