Protocol summary

Study aim
Determining the effect of the family-centered empowerment model on the parenting self-efficacy of mothers in relation to the growth and development process of toddlers
Design
Clinical trial with two control and intervention groups, randomized, phase one on 72 mothers of toddlers. Eighteen blocks of size 4 are used for randomization (block randomization).
Settings and conduct
The location of this study is in the children's ward of Amir Kabir Hospital in Arak, the study population is mothers of hospitalized toddlers. No blinding will be done in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Mothers with toddlers; The age range of the mothers is 20 to 45 years, the absence of mental and physical disabilities of the mother and the child, and having a 1 to 3 year old child hospitalized in the children's ward of Amir Kabir Hospital. Non-inclusion criteria: Simultaneous participation of subjects in similar educational programs
Intervention groups
The control group will received only the care available in the ward. Intervention group:The researcher implements the family-centered empowerment model intervention
Main outcome variables
Family-centered empowerment model; Mother's parenting self-efficacy score

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221230056985N1
Registration date: 2023-02-05, 1401/11/16
Registration timing: registered_while_recruiting

Last update: 2023-02-05, 1401/11/16
Update count: 0
Registration date
2023-02-05, 1401/11/16
Registrant information
Name
Mohammad Reza Shamshiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 5522 2815
Email address
m.r.shamshiri151276@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-05, 1401/10/15
Expected recruitment end date
2023-09-06, 1402/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating The Effect Of The Family-centered Empowerment Model On Mothers' Parenting Self-efficacy In Relation To The Growth And Development Process of Toddlers
Public title
Effect Of Family-centered Empowerment On Mothers' Self-efficacy In Relation To The Growth And Development Of Toddlers
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
The age range of mothers is 20 to 45 years No mental and physical disability of mother and child Having a 1-3 year old child hospitalized in the children's department of Amir Kabir Hospital The level of mother’s education of middle school degree up to doctorate
Exclusion criteria:
Simultaneous participation of subjects in similar educational programs
Age
From 12 months old to 36 months old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 72
Randomization (investigator's opinion)
Randomized
Randomization description
The samples are divided into two control and intervention groups by the accessible and easy sampling method and by the block randomization method. 18 blocks of size 4 are used to randomize the sample allocation to the two control and intervention groups.
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 Arak University Of Medical Sciences
Street address
Apadana Complex, Niloofar3 Alley, Pardis1 Residential Site
City
اراک
Province
Markazi
Postal code
3817686175
Approval date
2022-11-20, 1401/08/29
Ethics committee reference number
IR.ARAKMU.REC.1401.236

Health conditions studied

1

Description of health condition studied
This research is in line with the self-efficacy of the family and childcare system and promoting the growth and development of the toddler
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Mother's parenting self-efficacy score
Timepoint
Before the intervention, after the intervention and one month later
Method of measurement
Parenting self-efficacy questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The intervention researcher implements the family-centered empowerment model based on its four steps (threat understanding, self-efficacy, self-confidence and evaluation) in the form of group discussion in groups of four during five 60-minute sessions, one session every day for mothers. The content of the family-centered empowerment sessions related to the growth and development of toddlers is according to the valid references of children's growth and development, which has been approved by the professors of the children's department of the Arak Faculty of Nursing and Medical Sciences in terms of content validity.
Category
Other

2

Description
Control group: The control group does not receive the intervention of family-centered empowerment in relation to the growth and development of the toddler, and they only receive the care available in the department, and all children according to the national guidelines based on the Age and Stages of Development Questionnaire (ASQ). They are monitored by experts in health centers
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Arak Amir Kabir Hospital
Full name of responsible person
Mohammad Reza Shamshiri
Street address
Apadana complex,Niloofar3 alley,Pardis1 Residential Site
City
Arak
Province
Markazi
Postal code
3817686175
Phone
+98 918 436 7269
Email
m.r.shamshiri151276@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mahbobeh Sajadi
Street address
Apadana Complex,Niloofar3 Alley,Pardis1 Residential Site
City
َArak
Province
Markazi
Postal code
3817686175
Phone
+98 918 436 7269
Email
m.r.shamshiri151276@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Mohammad Reza Shamshiri
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Apadana Complex,Niloofar3 Alley,Pardis1 Residential Site
City
Arak
Province
Markazi
Postal code
3817686175
Phone
+98 918 436 7269
Email
m.r.shamshiri151276@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mahbobeh Sajadi
Position
Science Committee
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Apadana Complex,Niloofar3 Alley,Pardis1 Residential Site
City
Arak
Province
Markazi
Postal code
3817686175
Phone
008655222815
Email
m.r.shamshiri151276@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohammad Reza Shamshiri
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Apadana Complex,Niloofar3 Alley,Pardis1 Residential Site
City
Arak
Province
Markazi
Postal code
3817686175
Phone
008655222815
Email
m.r.shamshiri151276@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
Not applicable
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