<?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>IRCT20210204050236N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-02-13</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Emotion cognitive regulation Training in Impulsivity and Attitude toward Addiction</public_title>
      <acronym></acronym>
      <scientific_title>The Effectiveness of Emotion cognitive regulation Training in Impulsivity and Attitude toward Addiction among Children of the addict</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-03-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>24</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/54147</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Prevention, Randomization description: 1) Simple randomization was performed using a random number table and individually. Random even numbers were considered for the intervention group and odd numbers for the control group. Random numbers were also selected by individuals. Thus, each person selected a number from the table of random numbers. If this number was even, he would be in the intervention group, and if the selected random number was an odd number, he would be in the control group.
2) allocation concealment with using closed envelopes.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Impulsivity. Condition 2: Drug addiction.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The sample size of this group will be 12 people. In this group, cognitive regulation training based on the Gross's (2007) protocol of cognitive regulation and emotion will be held for 10 sessions, once a week for three months. The program of ten sessions will be as follows: Pre-tests and expressing the necessity of using emotion regulation in life, defining and recognizing types of emotions, training ways to increase positive experiences, ways to reduce negative emotions, identify wrong assessments and their effects on emotional states,  identify the extent and method of using the inhibition strategy and examine its emotional consequences, conscious attention to the current emotion, training to re-evaluate and express positive and negative emotions, training to evaluate emotions and pay attention to the consequences of each emotion, change negative emotions, the summary educational content of past sessions and post-test implementation. Intervention 2: Control group: The sample size of this group will be 12 people. There was no intervention in this 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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Qamar Kiani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Mansoori St., Moallem St., Etemadiyah</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>58145-45156</zip>
        <telephone>+98 24 3347 0293</telephone>
        <email>Shaker1339@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Qamar Kiani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Mansoori St., Moallem St., Etemadiyah</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>58145-45156</zip>
        <telephone>+98 24 3347 0293</telephone>
        <email>Shaker1339@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having a drug addicted parent
High score of addiction
Low score of impulsivity
Parental satisfaction</inclusion_criteria>
      <agemin>12 years</agemin>
      <agemax>18 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Taking drugs for mental illness</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R45.87</hc_code>
      <hc_code>F19.20</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Impulsiveness</hc_keyword>
      <hc_keyword>Other psychoactive substance dependence, uncomplicated</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The sample size of this group will be 12 people. In this group, cognitive regulation training based on the Gross's (2007) protocol of cognitive regulation and emotion will be held for 10 sessions, once a week for three months. The program of ten sessions will be as follows: Pre-tests and expressing the necessity of using emotion regulation in life, defining and recognizing types of emotions, training ways to increase positive experiences, ways to reduce negative emotions, identify wrong assessments and their effects on emotional states,  identify the extent and method of using the inhibition strategy and examine its emotional consequences, conscious attention to the current emotion, training to re-evaluate and express positive and negative emotions, training to evaluate emotions and pay attention to the consequences of each emotion, change negative emotions, the summary educational content of past sessions and post-test implementation.</i_keyword>
      <i_keyword>Control group: The sample size of this group will be 12 people. There was no intervention in this group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Cognitive regulation of excitement. Timepoint: Before the start and end of the training course. Method of measurement: Based on the Gross's model.</prim_outcome>
      <prim_outcome>Tendency to addiction. Timepoint: Before the start and end of the training course. Method of measurement: Based on a standard questionnaire.</prim_outcome>
      <prim_outcome>Impulsivity. Timepoint: Before the start and end of the training course. Method of measurement: Based on the Bart's impulsivity 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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-11-21</approval_date>
        <contact_name>Ethics committee of Islamic Azad University, Zanjan Branch</contact_name>
        <contact_address>Shahid Mansoori St., Moallem St., Etemadiyah Zanjan Zanjan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
