Protocol summary

Study aim
Determining the effect of health literacy education based on Bandura's social learning theory on self-care in working children
Design
Clinical trial with one intervention group, unblinded, randomized and with concealment, 75 samples, block randomization codes generated by Random Allocation Software.
Settings and conduct
The current research is a clinical trial type, the research population of which will include child labor aged 13-18 who refer to the Association for the Support of child labor in Molavi neighborhood located in Tehran. Available samples will be randomly collected and assigned to an intervention group. The health literacy training program will be conducted by the researcher during 60-90 minutes sessions in a total of 6 sessions.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. Willingness and satisfaction of the child and parents to participate in the research, 2. Having an age range of 13-18 years, 3. Not having physical and mental problems and disabilities based on the existing records of working children in the association, which can prevent self-care, 4. Not having any history of health literacy training Exclusion criteria: Absence (even one session of training sessions)
Intervention groups
In the health literacy training package, health literacy constructs (understanding, communication, reading, evaluation, access, use, self-efficacy and calculation) using Bandura's social-learning theory (attention, memorization, re-creation and motivation stage) in the intervention group We will upgrade.
Main outcome variables
Self-care

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230104057041N1
Registration date: 2023-02-02, 1401/11/13
Registration timing: prospective

Last update: 2023-02-02, 1401/11/13
Update count: 0
Registration date
2023-02-02, 1401/11/13
Registrant information
Name
Fatemeh Soleimantabar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6105 4424
Email address
f-soleimantabar@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-09, 1402/01/20
Expected recruitment end date
2023-04-20, 1402/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The impact of health literacy training based on bandura’s social learning theory on self-care in child labor
Public title
The impact of health literacy training on self-care
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness and consent of the child and parents to participate in the research Having an age range of 13-18 years Not having physical and mental problems and disabilities according to the existing records of child labor in the association, which can prevent self-care. Not having any history of health literacy training
Exclusion criteria:
Absence (even one session of training sessions)
Age
From 13 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 75
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committees of School of Nursing and Midwifery & Rehabilitation - Tehran University of Medical
Street address
School of Nursing and Midwifery, Tehran University of Medical Sciences, Dr. Mirkhani St. (East Nusrat), Tawheed Square
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2022-11-28, 1401/09/07
Ethics committee reference number
IR.TUMS.FNM.REC.1401.114

Health conditions studied

1

Description of health condition studied
Health literacy training & self-care
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Health literacy score in adolescent health literacy questionnaire
Timepoint
One month after the health literacy training intervention
Method of measurement
Adolescent health literacy questionnaire: Adolescent health literacy questionnaire has 8 subscales and 44 items, including access (5 items), reading (5 items), understanding (10 items), evaluation (5 items), use (4 items), communication ( 8 items), self-efficacy (4 items) and calculation (3 items) and on a 5-point Likert scale from never (score 1), rarely (score 2), sometimes (score 3), most of the time (score 4) and It is always graded (5 points).

2

Description
Self-care score in adolescent self-care questionnaire
Timepoint
One month after the health literacy training intervention
Method of measurement
Adolescent self-care questionnaire: Adolescent self-care questionnaire has 3 subscales and 48 items including physical self-care (17 items), psycho-social self-care (18 items) and emotional self-care (13 items). The options are scored on a Likert scale from always (score 4) to never (score 0) and the score ranges from 0 to 192.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Training will be done in the form of lectures, group discussions, questions and answers, role playing, intellectual games, using pictures and educational clips. We will promote the constructs of health literacy (comprehension, communication, reading, assessment, access, use, self-efficacy and calculation) using Bandura's social-learning theory (through a validated program). Bandura's observational learning model consists of the following four stages: 1) attention stage, 2) memorization stage, 3) recreation stage and 4) motivation stage. During each session, in the first stage, the attention of the audience will be attracted by the high knowledge of the presenter, stating the goals of the session, encouraging questions and answers in order to receive points; In the second stage, live, symbolic or symbolic models will be used to present the content (according to the content, videos, images, PowerPoint, speech, problem solving, and scenario implementation will be used to present the content); In the third stage, we will repeat and practice the learned material to consolidate what we have learned, as well as question and answer; In the fourth stage, according to the pre-determined rules, they will receive points.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Association for protection of child labor (Molavi Center)
Full name of responsible person
Fatemeh Abra Dari
Street address
No. 7, Shahid Mehdi Hosseini Alley, Shahid Mehdi Hosseini Alley, Shahrdari St., Borbor St., Mustafa Khomeini End
City
Tehran
Province
Tehran
Postal code
1168933263
Phone
+98 21 5557 6687
Email
info@apcl.org.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotohi
Street address
6th floor of Research and Technology Vice-Chancellor, Central Organization of the University, corner of Quds St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 8163 3685
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
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
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Soleimantabar
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Tawheed Square, Dr. Mirkhani St. (East Nusrat), School of Nursing and Midwifery, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4424
Fax
Email
f-soleimantabar@razi.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Soleimantabar
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Tawheed Square, Dr. Mirkhani St. (East Nusrat), School of Nursing and Midwifery, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4424
Fax
Email
f-soleimantabar@razi.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Soleimantabar
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Tawheed Square, Dr. Mirkhani St. (East Nusrat), School of Nursing and Midwifery, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4424
Fax
Email
f-soleimantabar@razi.tums.ac.ir

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
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