<?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>IRCT20221022056264N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-02-04</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>The effect of motivational interviewing on couples in need of genetic counseling</public_title>
      <acronym></acronym>
      <scientific_title>The effect of premarital counseling through motivational Interview on the knowledge, attitude and intention to refer to couples in need of genetic counseling</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-12-31</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/66712</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Random allocation: using the website www.random.org and through blocking with block sizes of four and six and an allocation ratio of 1:1 to the two groups of counseling and control.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Family history of mental retardation.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention will be implemented in three sessions once a week for 60-90 minutes, one face-to-face session and two online sessions in groups of 4-5 couples. In the first meeting, greeetings, stating the rules and goals of the meeting, encouraging couples to express their information, feelings and beliefs about genetic counseling and genetic diseases, introducing a motivational approach; Expressing the effects of having a baby with a genetic disorder in different aspects of life; Introducing the stages of change and doing exercises (thinking and reflection stage) and in the second session, answering the doubts and questions formed in the minds of couples and examining the existing problems and obstacles and the causes of resistance to genetic counseling, determining the advantages and disadvantages of changing behavior. The short-term evaluation of the advantages and disadvantages of genetic counseling (readiness to change behavior and action) and the third session of empowerment (transmission of correct information) and support, review of values, perspective and conclusions are expressed (maintenance stage). Intervention 2: Control group: They will receive routine care provided in Mashhad health centers number 1 and 2, which includes education about 6 genetic diseases (Duchen and Becker, Down syndrome, sickle cell anemia, G6PD, neural tube defects, hemophilia) and identification and follow-up of couples in need of genetic counseling.</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 There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Nahid Jahani Shurab</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery , Ibn Sina St., , Ph.D.Intersection,Daneshgah St.</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>jahaniShN@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nahid Jahani Shurab</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery , Doctor's intersection , Ibn Sina St.</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>jahaniShN@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Iranian couple
Have at least primary education.
Do not have addiction to tobacco and alcohol
Have an Android phone.
Based on the doctor's approval and the genetic screening questionnaire, they should have a genetic counseling indication at the time of marriage.
Couples who do not intend to do genetic counseling.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Diagnosis of a known psychiatric disorder in the couple (having a mood and anxiety disorder and being treated)
Uncertainty about continuing the research</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z81.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Family history of mental retardation (Conditions classifiable to F70-F79)</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: The intervention will be implemented in three sessions once a week for 60-90 minutes, one face-to-face session and two online sessions in groups of 4-5 couples. In the first meeting, greeetings, stating the rules and goals of the meeting, encouraging couples to express their information, feelings and beliefs about genetic counseling and genetic diseases, introducing a motivational approach; Expressing the effects of having a baby with a genetic disorder in different aspects of life; Introducing the stages of change and doing exercises (thinking and reflection stage) and in the second session, answering the doubts and questions formed in the minds of couples and examining the existing problems and obstacles and the causes of resistance to genetic counseling, determining the advantages and disadvantages of changing behavior. The short-term evaluation of the advantages and disadvantages of genetic counseling (readiness to change behavior and action) and the third session of empowerment (transmission of correct information) and support, review of values, perspective and conclusions are expressed (maintenance stage).</i_keyword>
      <i_keyword>Control group: They will receive routine care provided in Mashhad health centers number 1 and 2, which includes education about 6 genetic diseases (Duchen and Becker, Down syndrome, sickle cell anemia, G6PD, neural tube defects, hemophilia) and identification and follow-up of couples in need of genetic counseling.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Knowledge score in the knowledge questionnaire. Timepoint: The measurement periods will be before the intervention, immediately after the end of the intervention and one month after the intervention. Method of measurement: Knowledge questionnaire ( Researcher made ).</prim_outcome>
      <prim_outcome>Attitude score in the attitude questionnaire. Timepoint: The measurement periods will be before the intervention, immediately after the end of the intervention and one month after the intervention. Method of measurement: Attitude questionnaire based on Zaien study.</prim_outcome>
      <prim_outcome>Referral intention score in the questionnaire. Timepoint: The measurement periods will be before the intervention, immediately after the end of the intervention and one month after the intervention. Method of measurement: Referral intention questionnaire ( Researcher made ).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-10-04</approval_date>
        <contact_name>Ethics committee of the School of Nursing and Midwifery Mashhad University of Medical Sciences</contact_name>
        <contact_address>Qurashi Building, Daneshgah Street Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
