The effect of mothers' educational intervention on reproductive health of adolescent girls
Design
Randomized Controlled Trial, with case and control groups, Sample size 100 (50 samples per group)
Settings and conduct
Sampling is done randomly,First, all elementary and secondary schools in Shahroud are listed and one school is randomly selected, then the number of school students is listed and 50 mothers are randomly selected for each group. After coordination with the mothers, the research instrument is completed by the intervention and control groups. After 6 weeks of training for the intervention group, the research instrument is completed by both groups and then 3 months later.
Participants/Inclusion and exclusion criteria
Mothers residing in Shahrood;
Mothers have at least one daughter; ages 11-19 years old;
The girl is studying in one of the schools;
Satisfaction to participate in the survey.
Intervention groups
Mothers who are in the intervention group, using the educational package based on the results of qualitative study and literature review and is based on the educational needs of mothers regarding the reproductive health of adolescent girls (based on evidence), receive 6 90-minute training sessions per week. The booklet that has been prepared in this regard is also available to mothers. No action is taken for the control group. Only after the study, for ethical considerations, adolescent reproductive health education booklet given to the control group.
Main outcome variables
1. Understanding the Necessity of Adolescent Girls' Reproductive Health Education to Mothers
2. Educational content
3. Empowering Mothers in Promoting Adolescent Girls' Reproductive Health
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191229045929N1
Registration date:2020-06-15, 1399/03/26
Registration timing:retrospective
Last update:2020-06-15, 1399/03/26
Update count:0
Registration date
2020-06-15, 1399/03/26
Registrant information
Name
Shahrbanoo Salehin
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 5054
Email address
drbsalehin@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-21, 1398/11/01
Expected recruitment end date
2020-03-05, 1398/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of mothers' educational intervention on reproductive health of adolescent girls
Public title
The effect of mothers' educational intervention on reproductive health of adolescent girls
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Mothers residing in Shahrood
Mothers have at least one daughter, ages 11-19 years old.
The girl is studying in one of the schools
Satisfied to participate in the survey
Exclusion criteria:
Unwillingness to participate in the study
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
The random allocation method is using a quadruple block. According to the blocks, there are six states under ABBA 6-, 5- ABAB, 4- BAAB, BABA 3-, BBAA 2-, 1- AABB. Using random numbers table, obtained numbers are used for orders of blocks. Then 100 envelopes are prepared and numbered from 1 to 100 in the above order and the letters inside them are written. The word A or B is placed inside the envelopes.
Individuals receive one of these envelopes according to arrange entrance
to study and determine which group they belong to.
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 Faculty of Nursing and Midwifery of Shahid Beheshti University of Medical Scienc
Street address
School of Nursing and Midwifery, opposite Shahid Rajaei Heart Hospital, Naiayesh intersection, Valiasr Ave, Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2016-01-19, 1394/10/29
Ethics committee reference number
IR.SBMU.PHNM.1394.283
Health conditions studied
1
Description of health condition studied
Maternal educational needs about reproductive health of adolescent girls
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Understanding the Necessity of Adolescent Girls' Reproductive Health Education to Mothers
Timepoint
Before, immediately after and 3 months after intervention
Method of measurement
Questionnaire "Understanding the Necessity of Reproductive Health Education for Mothers"
2
Description
Educational content
Timepoint
Before, immediately after and 3 months after intervention
Method of measurement
Questionnaire "Educational characteristics of reproductive health"
3
Description
Empowering Mothers in Promoting Adolescent Girls' Reproductive Health
Timepoint
Before, immediately after and 3 months after intervention
Method of measurement
Questionnaire "Empowering Mothers in Promoting Adolescent Girls' Reproductive Health"
Secondary outcomes
1
Description
Mothers' knowledge of reproductive health of adolescent girls
Timepoint
Before, immediately after and 3 months after intervention
Method of measurement
questionnaire"Mothers' knowledge of reproductive health of adolescent girls"
Intervention groups
1
Description
Intervention group: using the educational package based on the results of qualitative study and literature review and educational needs of mothers regarding the reproductive health of adolescent girls (based on evidence), 6 training sessions (90-minute per week). The booklet that has been prepared in this regard is also available to mothers.
Category
Other
2
Description
Control group: Based on the quadruple blocking of mothers who are in the Control group, no action is taken for this group. Only after the study, for ethical considerations, adolescent reproductive health education booklet given to the control group.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Education of Shahroud
Full name of responsible person
Shahrbanoo Salehin
Street address
Azadi Ave.
City
Shahroud
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۷
Phone
+98 23 3222 7052
Email
drbsalehin@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Masumeh Simbar
Street address
Vali Asr Ave.
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
msimbar@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
30
Public or private sector
Private
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shahrbanoo Salehin
Position
PhD Student of Reproductive Health
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Tehran Ave.
City
Shahroud
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۷
Phone
+98 23 3239 5054
Email
drbsalehin@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shahrbanoo Salehin
Position
PhD Student of Reproductive Health
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Tehran Ave.
City
Shahroud
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۷
Phone
+98 23 3239 5054
Email
drbsalehin@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shahrbanoo Salehin
Position
PhD Student of Reproductive Health
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Tehran Ave.
City
Shahroud
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۷
Phone
+98 23 3239 5054
Email
drbsalehin@gmail.com
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