<?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>IRCT20250818066902N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-08-29</date_registration>
      <primary_sponsor>Tarbiat Modares University, Tehran</primary_sponsor>
      <public_title>Evaluating the effectiveness of childbearing education/counseling guidelines based on the Kirkpatrick model among service providers and its impact on knowledge, attitude, reproductive behavior, and motivation for childbearing in women</public_title>
      <acronym></acronym>
      <scientific_title>Evaluating the effectiveness of childbearing education/counseling guidelines based on the Kirkpatrick model among service providers and its impact on knowledge, attitude, reproductive behavior, and motivation for childbearing in women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-10-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>300</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/85801</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: To determine the effect of the new educational intervention based on new technologies, intervention group 1 will receive parenting education according to new methods, intervention group 2 will receive parenting education/counseling according to existing methods and content, and in the control group, individuals who have not received this education for any reason or may continue to receive it until the end of the year will be included in the study. In this study, all comprehensive health service centers covered will be included in the study, and the study will be conducted in each center on all three intervention groups 1, intervention 2, and the control group. In this study, random allocation of participants to three intervention groups 1, intervention 2, and control will be performed using the Stratified Random Allocation method. First, the entire sample will be divided into 17 blocks (based on the number of centers) based on comprehensive health service centers. Then, at each center, participants will be randomly assigned to one of three groups using a block randomization method, so that each center has a representative sample of all three groups. Randomization will be performed using the household file number in the SIB system and statistical software (such as Random Allocation Software or the randomization feature in SPSS) or a list of computer-generated random numbers. This method maintains a balance in the number of people in each group across all centers and allows for fair comparisons of interventions, Blinding description: Participants do not know which intervention or control group they are in.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Improving women's knowledge, attitudes, reproductive behavior, and motivation to have children.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The samples will be distributed to the intervention centers based on which of the 5 stages of behavior change they are in and will receive training in accordance with the Ministry of Health’s guidelines based on the Behavior Change Approach (SOC) and with full knowledge of the client. This approach helps the trainer/counselor to discover which stage of behavior change a woman eligible for childbearing is currently in and then adjusts their training content to suit that stage based on the Ministry of Health’s guidelines and presents it to the client. This training/counseling in intervention group 1 will be conducted in person and virtually, multimedia-based, in 10 60- and 30-minute training sessions.Intervention group 2 will also receive this training routinely based on the existing guidelines in 15 to 20 minutes.The control group will include eligible married women who have not received this training for any reason or may continue to receive it by the end of the year.Given the fact that training will be less effective if it is not model-based, the topics of the training session of this study will be based on the structures of the stages of change approach, which include the following:1) Pre-contemplation stage: In this stage, the individual has no intention or intention to change behavior in the next 6 months. Lack of information, motivation, resistance to change, and lack of readiness for intervention are the reasons for remaining in the pre-contemplation stage.2) Thinking stage: In the thinking stage, the individual intends to change behavior in the next 6 months, but these people constantly change their minds, it may take several weeks or months, or they may not even move on to the next stage. The educated classes stay in this stage more often.3) Preparation stage: In this stage, people have active plans for change in the next month. They have taken steps, however small, in this direction and are adjusting their lives accordingly. These people think whether they have the ability to change behavior? So, it is necessary to work on their self-confidence and remove obstacles from their path or help them remove obstacles.4) Action stage: In this stage, people have made a clear change in their behavior. Therefore, these people need encouragement and social and family support to remain in this stage and move on to the next stages.5) Continuation stage: In the continuation stage, people try to prevent a return to the previous behavior. More than 6 months have passed since the behavior change, this stage indicates the continuation of the new lifestyle. These people enjoy the resulting change and their self-confidence increases. Intervention 2: Control group: It will not receive any intervention and after the end of the study, educational content will also be provided to the control group.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is Due to the lack of a final publication plan and the need to review ethical and confidentiality considerations, no decision has been made to publish participant personal data (IPD) at this time.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Farzaneh Bani Hashemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Jalal Al Ahmad Highway, Street 7</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>141115111</zip>
        <telephone>+98 76 4432 2262</telephone>
        <email>Banihashemi.farzaneh@gmail.com</email>
        <affiliation>Tarbiat Modares University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Farzaneh Bani Hashemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Jalal Al Ahmad Highway, Street 7</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>141115111</zip>
        <telephone>+98 76 4432 2262</telephone>
        <email>Banihashemi.farzaneh@gmail.com</email>
        <affiliation>Tarbiat Modares University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Women must be married, have a husband, and live together.Be between the ages of 18 and 45.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></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>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The samples will be distributed to the intervention centers based on which of the 5 stages of behavior change they are in and will receive training in accordance with the Ministry of Health’s guidelines based on the Behavior Change Approach (SOC) and with full knowledge of the client. This approach helps the trainer/counselor to discover which stage of behavior change a woman eligible for childbearing is currently in and then adjusts their training content to suit that stage based on the Ministry of Health’s guidelines and presents it to the client. This training/counseling in intervention group 1 will be conducted in person and virtually, multimedia-based, in 10 60- and 30-minute training sessions.Intervention group 2 will also receive this training routinely based on the existing guidelines in 15 to 20 minutes.The control group will include eligible married women who have not received this training for any reason or may continue to receive it by the end of the year.Given the fact that training will be less effective if it is not model-based, the topics of the training session of this study will be based on the structures of the stages of change approach, which include the following:1) Pre-contemplation stage: In this stage, the individual has no intention or intention to change behavior in the next 6 months. Lack of information, motivation, resistance to change, and lack of readiness for intervention are the reasons for remaining in the pre-contemplation stage.2) Thinking stage: In the thinking stage, the individual intends to change behavior in the next 6 months, but these people constantly change their minds, it may take several weeks or months, or they may not even move on to the next stage. The educated classes stay in this stage more often.3) Preparation stage: In this stage, people have active plans for change in the next month. They have taken steps, however small, in this direction and are adjusting their lives accordingly. These people think whether they have the ability to change behavior? So, it is necessary to work on their self-confidence and remove obstacles from their path or help them remove obstacles.4) Action stage: In this stage, people have made a clear change in their behavior. Therefore, these people need encouragement and social and family support to remain in this stage and move on to the next stages.5) Continuation stage: In the continuation stage, people try to prevent a return to the previous behavior. More than 6 months have passed since the behavior change, this stage indicates the continuation of the new lifestyle. These people enjoy the resulting change and their self-confidence increases.</i_keyword>
      <i_keyword>Control group: It will not receive any intervention and after the end of the study, educational content will also be provided to the control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Improving women's awareness, attitudes, reproductive behavior, and motivation to have children. Timepoint: Study of knowledge, attitude, reproductive behavior and motivation to have children in women at the beginning of the study and three months after the end of the educational intervention. Method of measurement: Using the Knowledge, Attitude, Fertility Behavior, and Childbearing Motivation Questionnaire.</prim_outcome>
      <prim_outcome>Improving women's knowledge, attitudes, reproductive behavior, and motivation to have children. Timepoint: At the beginning of the study and three months after the end of the educational intervention. Method of measurement: Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Changing awareness, attitudes, reproductive behavior, and childbearing motivation in women. Timepoint: After the end of the intervention. Method of measurement: 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>Tarbiat Modares University, Tehran</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-07-27</approval_date>
        <contact_name>Ethics Committee of Tarbiat Modares University</contact_name>
        <contact_address>Jalal Al-Ahmad Highway - No. 7 Street, Tarbiat Modares University Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
