<?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>IRCT2016042717134N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-03-05</date_registration>
      <primary_sponsor>university of Tehran</primary_sponsor>
      <public_title>Evaluation of the Effectiveness of Pre-math Training and Executive Function</public_title>
      <acronym>Math Achievement</acronym>
      <scientific_title>Developing and Evaluating of Executive Function and Premath Skills Training Programs for Preschool Children at Risk of Mathematical Difficulties</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>160</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/15830</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Learning disability.</hc_freetext>
      <i_freetext>Intervention 1: Participants of intervention group will receive three different arms of intervention including: Arms one: Subjects will undergo the Maghzine, computerized executive functioning training with game elements, for 24 sessions over the span of 6 weeks. Each session will take 30-minute to complete. In addition to the Maghzine, the intervention group will play cognitive training games aimed at increasing working memory and inhibition skills. Intervention 2: Arms two: The intervention activities mainly were selected from three evidence based math curriculum. Lessons addressed teaching of shapes, space, algebraic thinking, geometry, counting, measurement, comparison, classifying and basics operations with worksheet, manipulative and computer-based activities matched with the designed curriculum. The intervention program included twenty-four sessions of math instruction carried out every day, five days a week in small-group formats. Intervention 3: Arms three: combination of pre-math training and executive function training. Intervention 4: Control group: will attend the routine preschool education including basic math training, art, music and English language.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ahmad Ahmadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Psychology &amp; Education, University of Tehran, Jalale Ale Ahmad Ave, Tehran, Iran.</address>
        <city>Teharn</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 6111 7457</telephone>
        <email>Ahmady457@ut.ac.ir</email>
        <affiliation>University of Tehran</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Ahmad Behpajooh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Psychology &amp; Education, University of Tehran, Jalale Ale Ahmad Ave, Tehran, Iran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 6111 7457</telephone>
        <email>behpajooh@ut.ac.ir</email>
        <affiliation>University of Tehran</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: subjects with low performance in mathematics, parent’s willingness to participate in research; lack of mental retardation or any other physical disabilities; having listening and speaking ability and they ranged in age from 5.5 to 6.5 years old. Exclusion criteria: participants, who are not eligible for the above, plus be under another intervention similar to the research intervention, if any, will be exclude.</inclusion_criteria>
      <agemin>5 years</agemin>
      <agemax>6 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F81.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Specific disorder of arithmetical skills</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Participants of intervention group will receive three different arms of intervention including: Arms one: Subjects will undergo the Maghzine, computerized executive functioning training with game elements, for 24 sessions over the span of 6 weeks. Each session will take 30-minute to complete. In addition to the Maghzine, the intervention group will play cognitive training games aimed at increasing working memory and inhibition skills.</i_keyword>
      <i_keyword>Arms two: The intervention activities mainly were selected from three evidence based math curriculum. Lessons addressed teaching of shapes, space, algebraic thinking, geometry, counting, measurement, comparison, classifying and basics operations with worksheet, manipulative and computer-based activities matched with the designed curriculum. The intervention program included twenty-four sessions of math instruction carried out every day, five days a week in small-group formats.</i_keyword>
      <i_keyword>Arms three: combination of pre-math training and executive function training</i_keyword>
      <i_keyword>Control group: will attend the routine preschool education including basic math training, art, music and English language.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Math skills. Timepoint: Baseline, post-treatment, 4 months after intervention. Method of measurement: Total Score on the Repeatable Battery for the Assessment of Math Achivement.</prim_outcome>
      <prim_outcome>Executive Functions Skills. Timepoint: Baseline, post-treatment, 4 months after intervention. Method of measurement: Tower of London, Behavior Rating Inventory of Executive Function, ,Stanford-Binet Intelligence Scales.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Working Memory Skills. Timepoint: Baseline, post-treatment, 4 months after intervention. Method of measurement: Working Memory Index of Stanford-Binet Intelligence Scales.</sec_outcome>
      <sec_outcome>Inhibition Skills. Timepoint: Baseline, post-treatment, 4 months after intervention. Method of measurement: Stroop test.</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>university of Tehran</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-07-12</approval_date>
        <contact_name>Faculty of Psychology &amp; Education</contact_name>
        <contact_address>chamran Highway, Jalale Ale Ahmad Ave, Faculty of Psychology &amp; Education Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
