<?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>IRCT20220605055078N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-06-14</date_registration>
      <primary_sponsor>معاونت تحقیقات و فناوری دانشگاه علوم پزشکی جندی شاپور اهواز</primary_sponsor>
      <public_title>The effect of counseling on maternal-fetal attachment in adolescent mothers</public_title>
      <acronym></acronym>
      <scientific_title>The effect of cognitive-behavioral counseling on maternal-fetal attachment in adolescent mothers</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-06-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>72</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/63956</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Education/Guidance, Randomization description: Samples will be selected by continuous sampling and will be divided into intervention and control groups by Block Balanced Randomization (BBR). The allocation sequence will be done using the free web system http://www.randomization.com/. In this way, the number of subjects in each block is determined by 6 people and the letter A will be considered for the intervention group and the letter B will be considered for the control group. The assignment sequence will be created for 72 samples by combining the letters A and B. Finally, the cards containing the blocks will be placed inside the standard envelope, and as a result, the Allocation Concealment will be considered and observed.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Relationship between cognitive-behavioral counseling on maternal and fetal attachment in adolescent mothers..</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Adolescent women with low maternal attachment score to the fetus receive 8 sessions of cognitive-behavioral counseling for 8 consecutive weeks. The number of people in the groups will be 6 and the duration of each session will be about 45 minutes. Each session has an educational purpose and during the session, they perform cognitive-behavioral change techniques. Homework is also recommended for women to permanently change the behavior appropriate to the topic of each session to increase maternal-fetal attachment to women. Intervention 2: Control group: Receive routine prenatal 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>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 It is done according to the opinion of the university and the supervisor</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Somayeh mohammadsoori</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ashuri Street</address>
        <city>Kangan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7557174373</zip>
        <telephone>009866364015</telephone>
        <email>smsoori.as@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mojgan javadnoori</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan St</address>
        <city>Ahwaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6135715794</zip>
        <telephone>009833114114</telephone>
        <email>javadnoori-m@ajums.ac.ir</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Primiparous mothers
Mother age from 15 to 19 years
The mother does not have an underlying physical or mental illness confirmed by a doctor and psychiatrist
Have at least a Middle school deploma
Gestational age at least 28 weeks
Existence of low attachment (based on the score of the first quarter questionnaire score 48)</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>19 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Withdrawal from continuing research
Incomplete of questionnaires
Absence of more than two sessions in counseling sessions
Fetal death
Divorce</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F69</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Unspecified disorder of adult personality and behavior</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: Adolescent women with low maternal attachment score to the fetus receive 8 sessions of cognitive-behavioral counseling for 8 consecutive weeks. The number of people in the groups will be 6 and the duration of each session will be about 45 minutes. Each session has an educational purpose and during the session, they perform cognitive-behavioral change techniques. Homework is also recommended for women to permanently change the behavior appropriate to the topic of each session to increase maternal-fetal attachment to women.</i_keyword>
      <i_keyword>Control group: Receive routine prenatal care.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Maternal-fetal attachment score of adolescent mothers in Cranley fetal-maternal attachment questionnaire. Timepoint: Completion of maternal-fetal attachment questionnaire before intervention, end of intervention and one month after intervention. Method of measurement: Cranley's Maternal-Fetal Attachment Questionnaire.</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>معاونت تحقیقات و فناوری دانشگاه علوم پزشکی جندی شاپور اهواز</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-05-30</approval_date>
        <contact_name>Ahwaz Jundishapur University of Medical Sciences</contact_name>
        <contact_address>Ahvaz Jundishapur University of Medical Sciences, School of Nursing and Midwifery, Golestan St Ahwaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
