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comparison of the Effectiveness of transition to parenthood programs the Family Foundation(FF) with Couples Care for Parents(CCP) on subjective well-being, marital conflict, and marital satisfaction new parents.

Protocol summary

Study aim
effectiveness of the family foundation education program and the care program for couples to become parents on mental well-being, marital conflicts, and marital satisfaction
Design
A clinical trial with the control group, with parallel groups, randomized, 90 couples
Settings and conduct
The location of the research is Ahvaz city health Center. It is a semi-experimental research of pre-test, post-test, and follow-up study with a control group.
Participants/Inclusion and exclusion criteria
90 couples based on a structured interview and criteria for entering the research, including being pregnant with the first child, mother's pregnancy month from 3 to 6 months, singleton pregnancy, no history of abortion or stillbirth, unwanted pregnancy, age of the couple between 20 and 40 years, education level of minimum diploma, exclusion criteria: physical distance and the decision to separate in couple, physical background (eg, heart disease, thalassemia major, etc.) and mental illnesses (eg, bipolar, depression), drug addiction
Intervention groups
The Family Foundation Program is an example of a global group intervention that lasts several months in the prenatal and postpartum periods. Experimental group 2, in four sessions during the 3rd to 6th month of pregnancy and four sessions after the fifth week. Participating in a parenting couple care program. The parenting couple care program is a relatively short-term structured program (about 12 hours of work per couple over 4-5 months). Control group participants participated in four virtual sessions and they will participate in parenthood preparation programs online.
Main outcome variables
subjective well-being, marital conflicts, and marital satisfaction of couples

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230709058725N1
Registration date: 2023-11-26, 1402/09/05
Registration timing: registered_while_recruiting

Last update: 2023-11-26, 1402/09/05
Update count: 0
Registration date
2023-11-26, 1402/09/05
Registrant information
Name
Ali sarvestani
Name of organization / entity
The University of Shahid Chamran
Country
Iran (Islamic Republic of)
Phone
+98 61 4372 8627
Email address
a-sarvestani@stu.scu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-05, 1402/08/14
Expected recruitment end date
2023-12-22, 1402/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of the Effectiveness of transition to parenthood programs the Family Foundation(FF) with Couples Care for Parents(CCP) on subjective well-being, marital conflict, and marital satisfaction new parents.
Public title
Effect of programs for the transition to parenthood
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
first pregnancy The second trimester of pregnancy The couple's age is between 20 and 40 Minimum education level is diploma Desired pregnancy singleton pregnancy
Exclusion criteria:
Couples who have physical distance and decide to separate. Having physical diseases such as thalassemia and heart Having mental illnesses such as bipolar disorder and acute depression, etc. Having drug addiction
Age
From 20 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 180
Randomization (investigator's opinion)
Randomized
Randomization description
In this project, two experimental groups and one control group will be used. In this research project, the sample size of 90 couples has been determined and the method of randomization allocation law will be used to allocate members to each group. This method represents a large block for It is the total sample size, which means that the balance in the number of people assigned to each of the groups will be achieved at the end of the study. For this purpose, a total sample size is first determined, then a group of them is randomly assigned to group A. We will allocate the set to group B and the rest to group c. The unit of randomization is pairwise.
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 shahid chamran university of Ahwaz
Street address
Golestan Blvd., Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
۶۱۳۵۷۸۳۱۵۱
Approval date
2023-11-05, 1402/08/14
Ethics committee reference number
IR.SCU.REC.1402.033

Health conditions studied

1

Description of health condition studied
Couples expecting their first child
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
The well-being score of the participants is on the Edinburgh Warwick Mental Well-Being Scale.
Timepoint
pre-test before the intervention (second trimester of pregnancy) and post-test 9 weeks after delivery, follow-up 60 days after the end of the intervention
Method of measurement
Warwick-Edinburg Mental Well-being Scale (WEMWBS)

2

Description
Marital conflict is the score that participants get on the Strauss Conflict Resolution Tactics Scale
Timepoint
pre-test before the intervention (second trimester of pregnancy) and post-test 9 weeks after delivery, follow-up 60 days after the end of the intervention
Method of measurement
Strauss Conflict Resolution Tactics Scale

3

Description
Marital satisfaction is the score obtained by the participants in Mehrabian's marital satisfaction scale
Timepoint
pre-test before the intervention (second trimester of pregnancy) and post-test 9 weeks after delivery, follow-up 60 days after the end of the intervention
Method of measurement
Mehrabian's Marital Satisfaction Scale

Secondary outcomes

1

Description
Mental health
Timepoint
pre-test before the intervention (second trimester of pregnancy) and post-test 9 weeks after delivery, follow-up 60 days after the end of the intervention
Method of measurement
Depression, Anxiety and Stress Questionnaire

Intervention groups

1

Description
Intervention group: This group includes those who are taught the family foundations program. The Family Foundation (FF) program is an example of a global group intervention that lasts several months in the prenatal and postpartum periods.
Category
Prevention

2

Description
Intervention group: This group includes those who are taught to become parents by the care program of couples. The couple care program for parenting is a relatively short-term structured program (about 12 hours of work per couple over 4-5 months).
Category
Prevention

3

Description
Control group: The participants of the control group will participate in four virtual and online parenthood preparation programs.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Health Centers of Ahvaz city
Full name of responsible person
Eshagh Sarvestani
Street address
Golestan Blvd., Ahvaz., Iran
City
Ahvaz
Province
Khouzestan
Postal code
6135783151
Phone
+98 61 3336 7008
Email
Alisarvestani@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid chamran university
Full name of responsible person
Seyed Abas Razavi
Street address
Golestan Blvd., Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
۶۱۳۵۷۸۳۱۵۱
Phone
+98 61 3322 6600
Email
alisarvestani@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid chamran 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
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid chamran of university
Full name of responsible person
Gholamreza Rajabi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Golestan Blvd., Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
6135783151
Phone
+98 61 3336 7008
Email
rajabireza@scu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid chamran university
Full name of responsible person
Gholamreza Rajabi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Golestan Blvd., Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
6135783151
Phone
+98 61 3336 7008
Email
rajabireza@scu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
SHahid chamran university
Full name of responsible person
Gholamreza Rajabi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Golestan Blvd., Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
6135783151
Phone
+98 61 3336 7008
Email
rajabireza@scu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
I will share the details of the educational protocol in the thesis and final paper. Also, in this research, only part of the data is shared, such as general information related to the main variables.پ
When the data will become available and for how long
I will share the protocol of this research before the end of the intervention in the form of articles in reputable journals. Access to data files begins 6 months after publication of results
To whom data/document is available
Data will be available only to researchers working in academic and scientific institutions and medical centers
Under which criteria data/document could be used
Only for scientific exchange among researchers who are interested in this field.
From where data/document is obtainable
To receive the data, contact the researcher via email. 1- Gholamreza Rajabi rajabireza@scu.ac.ir 2- Alisarvestani alisarvestani@yahoo.com
What processes are involved for a request to access data/document
Applicants must send their application to the administrator with the official letter of the university that is in operation. If the executive determines that the purpose of using the documents is to advance and exchange information, he will provide the documents to the applicant. It will be sent to them between one week and two months.
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