Protocol summary

Summary
The type of study is interventional. Objective: to evaluate the effect of two training methods of lecture and training package on knowledge, self-esteem and self-efficacy 9-12 year-old female students in relation to adolescent health. Inclusion criteria: 9-12 years female students of elementary school in the state; lack of participation in adolescent health education programs Exclusion criteria: death of a relative during the study; lack of participation in training sessions; lack of study training package in adolescent health; lack of enforcement training programs(the study training package and practice of lecture topics and training package during the study). The study population: all elementary school students in district 2 covers education in Alborz Province Education in 91-92 educational year. Sample size: A total of 270 cases randomly selected from among all the students with criteria inclusion into study, in elementary school students in district 2 covers education in Alborz Province who are willing to participate and divided into 3 groups, 90(2 intervention groups and 1 control group). Intervention: the first pre-test will be completed by all 3 groups. 3 sessions of 45 minutes(according adolescent health issues, self-esteem and self-efficacy in adolescents) will be held for the first intervention group and the second intervention group training package that contains topics of the first intervention group. A control group to be considered for both of intervention groups. 3 months later, post-test is completed by the participants.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201304145912N9
Registration date: 2013-11-08, 1392/08/17
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-11-08, 1392/08/17
Registrant information
Name
Mandana Mir Mohammad Ali Ei
Name of organization / entity
Tehran University of Medical Scinces
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
mirmohammad@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2013-05-22, 1392/03/01
Expected recruitment end date
2013-09-29, 1392/07/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the impact of two training methods of lecture and training package on the student's knowledge, self-esteem and self-efficacy 9-12 year-old female students in relation to adolescent health
Public title
The impact of two training methods of lecture and training package on the student's knowledge, self-esteem and self-efficacy 9-12 year-old female students in relation to adolescent health
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: 9-12 years female students of elementary school in the state; lack of participation in adolescent health education programs Exclusion criteria: death of a relative during the study; lack of participation in training sessions; lack of study training package in adolescent health; lack of enforcement training programs(the study training package and practice of lecture topics and training package during the study)
Age
From 9 years old to 12 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 270
Randomization (investigator's opinion)
Randomized
Randomization description
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
Tehran University of Medical Sciences
Street address
The sixth floor, Central Building of Tehran University of Medical Sciences Tehran, Ghods St., Keshavarz Blvd.
City
Tehran
Postal code
Approval date
2013-03-18, 1391/12/28
Ethics committee reference number
3429/130/د/91

Health conditions studied

1

Description of health condition studied
health education
ICD-10 code
Z71.9
ICD-10 code description
medical advice NOS

Primary outcomes

1

Description
knowledge
Timepoint
Beginning of the study, 3 months after begining of the study
Method of measurement
Questionnaire

2

Description
Self-steem
Timepoint
Beginning of the study, 3 months after begining of the study
Method of measurement
Questionnaire

3

Description
Self-efficacy
Timepoint
Beginning of the study, 3 months after begining of the study
Method of measurement
Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
In the first intervention group (lecture): The first students to complete the questionnaire pre-test and then participate in three 45-minute sessions on adolescent health, self-esteem and self-efficacy that is the questions and answers. Finally, the participants will be asked after the intervention period(3 months) to respond to the questionnaire post-test, the back reference to refrence school.
Category
Prevention

2

Description
The intervention group received training package: Students must complete a pre-test questionnaire and a training package that contains topics about adolescent health, self-esteem and self-efficacy is to be delivered to students and the student must be study topics of training package in a week and answered a questionnaire to fill again after 3 months post-test, the back to refrence school.
Category
Prevention

3

Description
In the control group: students completed the pretest questionnaire at baseline and then after 3 months without any intervention return back to reference school to complete a post-test questionnaire.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Almahdi Female Elementry School
Full name of responsible person
Mahboobeh heydari
Street address
Almahdi Female Elementry School, before Estandard Square, Mesbah Interjunction, Karaj, Alborz
City
Karaj

2

Recruitment center
Name of recruitment center
Asadabadi Female Elementry School
Full name of responsible person
Mahboobeh heydari
Street address
Asadabadi Female Elementry School, Shahid Fahmideh square, Karaj, Alborz
City
Karaj

3

Recruitment center
Name of recruitment center
Shahid Darashti Female Elementry School
Full name of responsible person
Mahboobeh heydari
Street address
Shahid Darashti Female Elementry School, Enterance Sheykh Abad, Karaj, Alborz
City
Karaj

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Council of Tehran University of Medical Sciences
Full name of responsible person
Fotouhi Akbar doctor - Research Assistant
Street address
Jerusalem headquarters on the sixth floor, Tehran University of Medical Sciences St., Keshavarz Blvd Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Council of Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mandana Mir Mohammad Ali E.
Position
Master of Midwifery
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 6692 7171
Fax
Email
mirmohamad1@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mandana Mir Mohammad Ali E.
Position
Master of Midwifery
Other areas of specialty/work
Street address
Faculty Nursing and Midwifery, Tehran University of Medical Sciences, Tohid Square, Tehran
City
Tehran
Postal code
Phone
+98 21 6692 7171
Fax
Email
mirmohamad1@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahboobeh heydari
Position
Student Master of Midwifery
Other areas of specialty/work
Street address
Unit 2, Plaque 19, Nastaran Lane, Avenue 12, The first dehghanvila, Karaj, Alborz
City
Karaj
Postal code
Phone
+98 26 3464 7506
Fax
Email
mahboobehheydari@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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