<?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>IRCT20220706055392N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-08-30</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Applying emotion-oriented couple therapy on the quality of marital relationship and psychological and social adjustment of children</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effectiveness of emotion-oriented couple therapy on the quality of married life and the psychological and social adjustment of children in people referring to psychological clinics and comparing it with the control group.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-09-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64857</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Health service research, Randomization description: In this study, the participants will be selected by the available sampling method and put into experiment and control groups through drawing (in this method, each member is given a specific number; then all numbers are put together and will be drawn randomly for each group.).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Psychosocial incompatibility.</hc_freetext>
      <i_freetext>Intervention 1: The first group (experimental group) will receive emotion-oriented couple therapy, which consists of eight ninety-minute sessions, one session per week. The first session: conducting a pre-test, getting to know and establishing a therapeutic relationship, getting to know the general rules of treatment, introducing an emotion-oriented approach, evaluating the goals and expectations of the spouses from the treatment, evaluating the nature of the problem and relationship, giving assignments(In each session, the summary of the previous session is reviewed and assignments are checked)The second session: identifying the negative interactive cycle and learning to reveal it, evaluating the attachment problem and obstacles, familiarizing the couple with the role of emotions in interactions and rebuilding interactions and increasing flexibility. The third session: Achieving basic emotions with negative interactions, creating a safe communication space for couples, focusing on the secondary emotions of the couple in their interactions to achieve basic emotions, discussing primary emotions and processing them and raising couples' awareness of primary emotions, presenting homework. The fourth session: reframing the problem by examining the cycle with underlying emotions and attachment needs, emphasizing the client's ability to express emotions and show attachment behaviors to the spouse. The fifth session: feeling close to the rejected emotional emotions that are denied in the individual, drawing the attention of the couple to the way they interact with each other, expressing attachment needs. The sixth session: making people aware of the underlying emotions, revealing the position of each spouse in the relationship, emphasizing the acceptance of the spouse's experiences and new solutions for interaction, giving assignments. Seventh session: facilitating the expression of desires and needs based on a new understanding of spouses and creating bonding events, creating a new attachment between spouses with a safe bond. Eighth session: Creating new interactive situations between couples and ending old patterns, clarifying interactive patterns, reminding attachment needs. Intervention 2: The participants of the control group do not receive any intervention, they only receive and complete the package of questionnaires before and after the intervention for the experimental 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 Considering that this plan is examined from a psychological point of view, I must finally check the opinions of the participants and publish the data file with their consent.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hale nematolahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad University, University Town, Semnan Province</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>983513137111</zip>
        <telephone>+98 23 3365 4040</telephone>
        <email>Hale.nematolahi@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hale Nematolahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad University,  University Town,  Semnan Province</address>
        <city>semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>983513137111</zip>
        <telephone>+98 23 3365 4040</telephone>
        <email>hale.namatolahi@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having a child in the age range of 7 to 12 years; having behavioral problems based on interviews
questionnaires agreeing to participate in the research
having at least a diploma education</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The presence of active marital infidelity
Receiving any type of couples therapy at the same time
Receiving any type of concurrent psychological treatment for your child's behavioral problems
Received emotion-oriented couple therapy intervention so far
The person's unwillingness to continue the treatment process
People suffering from a psychiatric illness that affects their vision, behavior, and tolerance to participate in treatment (if the disease is controlled, there was no obstacle to participating in the research)</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>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The first group (experimental group) will receive emotion-oriented couple therapy, which consists of eight ninety-minute sessions, one session per week. The first session: conducting a pre-test, getting to know and establishing a therapeutic relationship, getting to know the general rules of treatment, introducing an emotion-oriented approach, evaluating the goals and expectations of the spouses from the treatment, evaluating the nature of the problem and relationship, giving assignments(In each session, the summary of the previous session is reviewed and assignments are checked)The second session: identifying the negative interactive cycle and learning to reveal it, evaluating the attachment problem and obstacles, familiarizing the couple with the role of emotions in interactions and rebuilding interactions and increasing flexibility. The third session: Achieving basic emotions with negative interactions, creating a safe communication space for couples, focusing on the secondary emotions of the couple in their interactions to achieve basic emotions, discussing primary emotions and processing them and raising couples' awareness of primary emotions, presenting homework. The fourth session: reframing the problem by examining the cycle with underlying emotions and attachment needs, emphasizing the client's ability to express emotions and show attachment behaviors to the spouse. The fifth session: feeling close to the rejected emotional emotions that are denied in the individual, drawing the attention of the couple to the way they interact with each other, expressing attachment needs. The sixth session: making people aware of the underlying emotions, revealing the position of each spouse in the relationship, emphasizing the acceptance of the spouse's experiences and new solutions for interaction, giving assignments. Seventh session: facilitating the expression of desires and needs based on a new understanding of spouses and creating bonding events, creating a new attachment between spouses with a safe bond. Eighth session: Creating new interactive situations between couples and ending old patterns, clarifying interactive patterns, reminding attachment needs.</i_keyword>
      <i_keyword>The participants of the control group do not receive any intervention, they only receive and complete the package of questionnaires before and after the intervention for the experimental group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Primary outcome variable: quality of life score in( RDAS) questionnaire. Timepoint: Before the start of the intervention, and after ten weekly intervention sessions. Method of measurement: How to measure: using Busby et al.'s Marital Quality Scale (RDAS).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Secondary outcome variable: score in cbcl questionnaire. Timepoint: Before the start of the intervention, and after ten weekly intervention sessions. Method of measurement: How to measure: using the Achenbach Child Behavior Inventory-Parent Version (cbcl).</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-07-16</approval_date>
        <contact_name>Islamic Azad University of Semnan, Department of Medical Sciences</contact_name>
        <contact_address>Islamic Azad University Street Semnan Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
