<?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>IRCT20230116057137N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-04-26</date_registration>
      <primary_sponsor>Safahan Institute of Higher Education</primary_sponsor>
      <public_title>Effect of Adolescent-Centered Mindfulness Treatment and Emotion Regulation on High-Risk Behaviors, Mind Wandering and Symptoms of Depression.</public_title>
      <acronym>MBT</acronym>
      <scientific_title>Comparison of the effectiveness of Adolescent-Centered Mindfulness Treatment and Emotion Regulation Strategies Training on High-Risk Behaviors, Mind Wandering and Symptoms of Depressed Adolescents</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-04-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68096</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Education/Guidance, Other design features: A factorial trial with a design provides separate assessment of the effects of more than one treatment, Randomization description: Random method: simple random draw
Randomization Unit: Individual
Randomization tool: Lottery
The numbers 1-60 are randomly distributed among 60 subjects, then we put the numbers 1-60 in the box and the first 15 numbers out of the box are in the first test group and the second 15 numbers are in the second test group and the remaining people in the group are under control, Blinding description: Double-blind means that the people in the sample group did not know whether they were in the experimental group or the control group.
Therefore, explaining the objectives of the research only for the experimental group and ignorance of the selection in the two groups was the blinding method of the present study, considering that after the work was completed, the treatment was also applied to the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>High-Risk Behaviors, Mind Wandering, Depression.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: First, the first experimental group underwent eight weekly sessions of 60 minutes of adolescent-oriented mindfulness using the manual for teaching mindfulness skills to children and adolescents by Burdick . Intervention 2: Intervention group: Second, the second experimental group underwent eight weekly sessions of 60 minutes of emotion regulation strategies training using the book Emotion Regulation Strategies by Grass. Intervention 3: Control group: They did not receive any intervention.</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 further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nooshin Salahi Esfahani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 8,  Afshin Alley, Khaghani Street</address>
        <city>Esfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8175857174</zip>
        <telephone>+98 31 3628 3309</telephone>
        <email>nse1375@yahoo.com</email>
        <affiliation>Safahan Institute of Higher Education</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nooshin Salahi Esfahani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 8,Afshin Alley, Khaghani Street</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8175857174</zip>
        <telephone>+98 31 3628 3309</telephone>
        <email>nse1375@yahoo.com</email>
        <affiliation>Safahan Institute of Higher Education</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>1. Age range 13-17 years
2. Being able to read and write
3. Not suffering from acute or chronic mental disorders during the past week (confirmed by a psychiatrist or clinical psychologist)
4. Not using simultaneous psychological treatments
5. Not taking psychiatric drugs for the past 3 months (by asking clients)
6. Not suffering from physical diseases (diagnosed by a doctor and acknowledged by the client)</inclusion_criteria>
      <agemin>12 years</agemin>
      <agemax>18 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Being over 18 years old
Suffering from physical and movement diseases
Being illiterate or illiterate
Suffering from chronic psychological diseases
People undergoing psychological treatment.
People who are taking psychiatric medication.</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>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: First, the first experimental group underwent eight weekly sessions of 60 minutes of adolescent-oriented mindfulness using the manual for teaching mindfulness skills to children and adolescents by Burdick .</i_keyword>
      <i_keyword>Intervention group: Second, the second experimental group underwent eight weekly sessions of 60 minutes of emotion regulation strategies training using the book Emotion Regulation Strategies by Grass.</i_keyword>
      <i_keyword>Control group: They did not receive any intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>People who, in addition to having files in counseling centers with a diagnosis of depression, scored more than 20 in Beck's depression questionnaire. Timepoint: Investigating depression at the beginning of the study, 60 and 45 days after the intervention. Method of measurement: Beck depression questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Reducing High_Risk behaviors. Timepoint: At the beginning of the study and 60 and 45 days after the intervention. Method of measurement: Questionnaire of risky behaviors.</sec_outcome>
      <sec_outcome>Reducing mind wandering. Timepoint: At the beginning of the study and 60 and 45 days after the intervention. Method of measurement: Wandering Mind 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>Safahan Institute of Higher Education</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-12-05</approval_date>
        <contact_name>Ethics committee of Isfahan University</contact_name>
        <contact_address>No. 8, Afshin Alley, Khaghani Street Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
