<?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>IRCT20221206056729N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-12-29</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>Effect of the training program on adaptation to the parental role in first-time parents</public_title>
      <acronym></acronym>
      <scientific_title>Designing and evaluating the effectiveness of the intervention based on the educational needs of adapting to the parental role in first-time parents, a multi-stage study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-01-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>176</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/67609</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: After the initial selection of the samples by easy sampling, they will be divided into two groups using a random block of 4 and 6, with an allocation ratio of 1:1. After listing all the possible states of blocks 4 and 6 and assigning a number to each of them using a computerized random number table with a ratio of 1:1, people will be divided into two groups receiving training and routine care. To conceal the allocation, the type of intervention will be written on paper and placed in sequentially numbered opaque envelopes. The researcher and the participant will not know how to group and intervene until the start of the study.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Parenting educational program.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the intervention group, women with 33-34 weeks of pregnancy and their husbands, who have been referred to health centers in Ahvaz for perinatal care, are invited to enter the study. They will be offered three face-to-face training sessions at 34, 35, and 36 weeks. In group classes of 4 to 8 people, each session will last 45-60 minutes. The educational content will be on psychological issues, the embodiment of maternal and paternal roles, infant interaction skills, and general infant care. The educational information of the sessions will be presented to the group members through lectures, discussions, role plays, and whiteboards. Intervention 2: Control group: Women with 33-34 weeks of pregnancy and their husbands, who have been referred to Ahvaz health centers for perinatal care, will be received pregnancy care from the health centers. Providing care in this group is routine, and the researcher will not interfere in their pregnancy care.</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:
The data can be published after the completion of the thesis.

When:
One year after finishing the thesis.

To whom:
Ahvaz Jundishapur University of Medical Sciences, hospital and university researchers.

Conditions:
After analysis, the data will be available to others through publication in scientific research journals.

Where to obtain:
Forough Talebi, email: 25farzanehh58@gmail.com

How to obtain:
Information will be available through printing the article. But if the person wants more information, he can express his request through email.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Abbaspoor</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Midwifery, School of Midwifery Nursing, Jundishapur University of Medical Sciences of Ahvaz, Golestan Blvd.</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>61357-15794</zip>
        <telephone>+98 61 3373 8331</telephone>
        <email>Abbaspoor_z762@yahoo.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Forough Talebi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 5, Payam Alley, East Soleimani Ave., Chizar.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1938874494</zip>
        <telephone>+98 21 2223 9245</telephone>
        <email>25farzanehh58@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>First-time parents
18-45 years
low risk and singleton pregnancy
Wanted pregnancy
willingness to participate in the study
Ability to speak and understand Farsi language
33-34 weeks of pregnancy</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Drug abuse
Medical problems (such as  preterm labor, GDM, preeclampsia...)
Healthy fetus
Chronic maternal and physical disease in parents</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F43.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Adjustment disorders</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the intervention group, women with 33-34 weeks of pregnancy and their husbands, who have been referred to health centers in Ahvaz for perinatal care, are invited to enter the study. They will be offered three face-to-face training sessions at 34, 35, and 36 weeks. In group classes of 4 to 8 people, each session will last 45-60 minutes. The educational content will be on psychological issues, the embodiment of maternal and paternal roles, infant interaction skills, and general infant care. The educational information of the sessions will be presented to the group members through lectures, discussions, role plays, and whiteboards.</i_keyword>
      <i_keyword>Control group: Women with 33-34 weeks of pregnancy and their husbands, who have been referred to Ahvaz health centers for perinatal care, will be received pregnancy care from the health centers. Providing care in this group is routine, and the researcher will not interfere in their pregnancy care.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Maternal role adaptation. Timepoint: 4 weeks after the intervention. Method of measurement: Maternal Role Adaptation Questionnaire.</prim_outcome>
      <prim_outcome>Paternal role adaptation. Timepoint: 4 weeks after the intervention. Method of measurement: Paternal Adaptation Questionnaire.</prim_outcome>
      <prim_outcome>Parenting Sense of Competence. Timepoint: Before the intervention, immediately after the intervention and 4 weeks after the intervention. Method of measurement: Parenting Sense of Competence Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The rate of exclusive breastfeeding. Timepoint: After the baby is born and 4 weeks after the intervention. Method of measurement: A questionnaire made by the researcher.</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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-08-28</approval_date>
        <contact_name>Ethics committee of Ahvaz Jundishapur University of Medical Sciences</contact_name>
        <contact_address>Room 4, Ground floor, Vice President of Research and Technology Development, Jundishapur University of Medical Sciences of Ahvaz, University City, Golestan Blvd. Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
