<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20230709058725N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-11-26</date_registration>
      <primary_sponsor>Shahid chamran university</primary_sponsor>
      <public_title>Effect of programs for the transition to parenthood</public_title>
      <acronym></acronym>
      <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.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-11-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>180</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/73241</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, 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.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Couples expecting their first child.</hc_freetext>
      <i_freetext>Intervention 1: 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. Intervention 2: 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). Intervention 3: Control group: The participants of the control group will participate in four virtual and online parenthood preparation programs.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
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:
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 will be available only to researchers working in academic and scientific institutions and medical centers

Conditions:
Only for scientific exchange among researchers who are interested in this field.

Where to obtain:
To receive the data, contact the researcher via email.
1- Gholamreza Rajabi              rajabireza@scu.ac.ir
2- Alisarvestani                                alisarvestani@yahoo.com

How to obtain:
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.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Gholamreza Rajabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan Blvd., Ahvaz, Iran</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6135783151</zip>
        <telephone>+98 61 3336 7008</telephone>
        <email>rajabireza@scu.ac.ir</email>
        <affiliation>Shahid chamran of university</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Gholamreza Rajabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan Blvd., Ahvaz, Iran</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6135783151</zip>
        <telephone>+98 61 3336 7008</telephone>
        <email>rajabireza@scu.ac.ir</email>
        <affiliation>Shahid chamran university</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <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</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <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</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>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.</i_keyword>
      <i_keyword>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).</i_keyword>
      <i_keyword>Control group: The participants of the control group will participate in four virtual and online parenthood preparation programs.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>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).</prim_outcome>
      <prim_outcome>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.</prim_outcome>
      <prim_outcome>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.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>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.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Shahid chamran university</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-11-05</approval_date>
        <contact_name>Ethics committee of shahid chamran university of Ahwaz</contact_name>
        <contact_address>Golestan Blvd., Ahvaz, Iran Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
