<?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>IRCT20230621058549N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-02-25</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Effectiveness of mentalization based treatment in mothers on their children's behavioral problems</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness and mechanism of change of mentalization based treatment in mothers with persistent depressive disorder on their children's behavioral problems</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-07-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>34</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70977</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Education/Guidance, Randomization description: Randomization will be achieved using the of web-based randomization. Web-based randomization is one of the methods of generating a simple random sequence, which is initially assigned a number to each participant and then using the website, people are randomly assigned to the intervention and control groups.
This process will be done using the www.graphpad.com website. Considering that the sample size is 34 participants (17 participants in each group), a number from 1 to 34 will be assigned to each person and It is defined on the website that these numbers will be randomly assigned to one of the two intervention (A) and control (B) groups. In this way, the assigned number in each group indicates the placement of the participant in that group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Children's Behavioral Problems.</hc_freetext>
      <i_freetext>Intervention 1: Control group: There will be a waiting list in such a way that individuals will not receive treatment until the end of the research project, and at that time they will receive the present intervention. Intervention 2: Intervention group: The mentalization based treatment that will be implemented in the present study is a program developed by Burn et al. (2019) under the title of Lighthouse Parenting Program. This program, which consists of 16 sessions of 1.5 hours and is held once a week in groups, is specifically designed for at-risk parents with a special focus on child development. The purpose of the program is to improve the mentalizing capacity, that is, parents' active curiosity about the child's inner world and efficient and productive reflection and reflection of their thoughts, feelings and reactions. This program helps parents approach their children with an inquisitive mindset, identify where and how their parenting mindset can fail, and try to fix their mindset when they fail. This process represents the central metaphor of the program; The lighthouse metaphor presents parents as beacons who should provide gentle light for their child's journey and be a guiding light that can guide the child to the shore when support, help or comfort is needed.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is It is possible to misuse individual raw data</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zeinab Razmzan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 1, Shahid Mansouri St., Niayesh St., Sattar Khan St</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۴۴۵۶۱۳۱۱۱</zip>
        <telephone>+98 21 6655 1668</telephone>
        <email>zeinabrazmzan@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zeinab Razmzan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 1, Shahid Mansouri St., Niayesh St., Sattar Khan St</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1445613111</zip>
        <telephone>+98 21 6655 1668</telephone>
        <email>zeinabrazmzan@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having a diagnosis of persistent depressive disorder based on DSM-5 criteria
Having a child in the age range of 6 to 11 with behavioral problems
The age of the mother is between 25 and 50 years
Not participation in other parent training sessions during this clinical trial</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>50 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>The presence of acute symptoms of the disease in the mother so that she cannot answer the questions
Having psychotic symptoms
Having bipolar disorder and related disorders
Having substance related and addictive disorders
Intellectual disability in mother
Intellectual disability in child
Having autism spectrum disorders in mother
Having autism spectrum disorders in mother
Child's participation in psychotherapy or pharmacological therapy
Having suicidal ideation in the mother</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>Other</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: There will be a waiting list in such a way that individuals will not receive treatment until the end of the research project, and at that time they will receive the present intervention.</i_keyword>
      <i_keyword>Intervention group: The mentalization based treatment that will be implemented in the present study is a program developed by Burn et al. (2019) under the title of Lighthouse Parenting Program. This program, which consists of 16 sessions of 1.5 hours and is held once a week in groups, is specifically designed for at-risk parents with a special focus on child development. The purpose of the program is to improve the mentalizing capacity, that is, parents' active curiosity about the child's inner world and efficient and productive reflection and reflection of their thoughts, feelings and reactions. This program helps parents approach their children with an inquisitive mindset, identify where and how their parenting mindset can fail, and try to fix their mindset when they fail. This process represents the central metaphor of the program; The lighthouse metaphor presents parents as beacons who should provide gentle light for their child's journey and be a guiding light that can guide the child to the shore when support, help or comfort is needed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Child Behavioral Problems. Timepoint: Before the start of the intervention, immediately after the end of the intervention, 4 months after the end of the intervention. Method of measurement: Child Behavior Check List.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Parental Reflective Functioning. Timepoint: Before the start of the intervention, after the eighth session of the intervention, immediately after the end of the intervention, 4 months after the end of the intervention. Method of measurement: Parental Reflective Functioning Questionnaire.</sec_outcome>
      <sec_outcome>Attachment Styles. Timepoint: Before the start of the intervention, after the eighth session of the intervention, immediately after the end of the intervention, 4 months after the end of the intervention. Method of measurement: Adult Attachment Style.</sec_outcome>
      <sec_outcome>Emotion Regulation. Timepoint: Before the start of the intervention, after the eighth session of the intervention, immediately after the end of the intervention, 4 months after the end of the intervention. Method of measurement: Difficulties in Emotion Regulation Scale.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-05-24</approval_date>
        <contact_name>Research Ethics committee of Iran University of Medical Sciences</contact_name>
        <contact_address>5th Floor of the Central Headquarters, Iran University of Medical Sciences, Next to Milad Tower, Hemat Highway, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
