<?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>IRCT20251230068502N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-01-03</date_registration>
      <primary_sponsor>Shahid Beheshti University</primary_sponsor>
      <public_title>Effectiveness of Response to intervention Model in Reading performance and Executive functions of students with dyslexia</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness of Response to intervention Model in Reading performance and Executive functions of students with dyslexia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-02-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/88443</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Eligible students were randomly assigned to the intervention (Response to Intervention model) or control group using a simple lottery-based randomization method after obtaining written parental consent.
Sequentially numbered, opaque, sealed envelopes containing group assignments were prepared in advance by an independent person. One envelope was opened sequentially for each participant only after enrollment, ensuring adequate allocation concealment and minimizing selection bias.
The unit of randomization was the individual student, and no stratified randomization was applied.</study_design>
      <phase>N/A</phase>
      <hc_freetext>The variables studied were executive functions and reading performance in students with reading disorders..</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Regarding grade level, in the experimental group, the largest number of participants were in the second grade (5 students; 33.3%). The first, third, and fourth grades each included 3 students (20%), while the fifth grade had the fewest participants (1 student; 6.7%). Intervention 2: Control group: The control group consisted of 15 students who did not receive any intervention. The largest number of participants were 8-year-olds (5 students, 33.3%). This was followed by 7-year-olds (4 students, 26.7%), 9-year-olds (3 students, 20%), 11-year-olds (2 students, 13.3%), and 10-year-olds (only 1 student, 6.7%).</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
The data are shareable.

When:
Access will begin six months after publication.

To whom:
The data will be available to researchers and academic institutions.

Conditions:
The data will be available for future research purposes.

Where to obtain:
Researcher: Samaneh Tajik Khave
Email: tajik1031@gmail.com

How to obtain:
The data will be provided upon email request along with a description of the study.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Samaneh Tajik Khaveh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 10, Alley 606, Fajr 6th Street, Fajr Street</address>
        <city>Varamin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3371738393</zip>
        <telephone>+98 21 3626 4944</telephone>
        <email>tajik1031@gmail.com</email>
        <affiliation>Shahid Beheshti University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Samaneh Tajik Khaveh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 10, Alley 606, Fajr 6th Street, Fajr Street</address>
        <city>Varamin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3371738393</zip>
        <telephone>+98 21 3626 4944</telephone>
        <email>tajik1031@gmail.com</email>
        <affiliation>Shahid Beheshti University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Enrollment of the student at the elementary school level
No concurrent participation in other intervention programs
Student’s readiness and ability to attend the intervention sessions regularly
Absence of serious uncorrected hearing or visual impairments, or severe psychological disorders that may affect reading performance
Absence of serious uncorrected hearing or visual impairments, or severe psychological disorders that may affect reading performance
Confirmation of the student’s learning disorder by a specialist from a learning disabilities center</inclusion_criteria>
      <agemin>7 years</agemin>
      <agemax>12 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></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>Intervention group: Regarding grade level, in the experimental group, the largest number of participants were in the second grade (5 students; 33.3%). The first, third, and fourth grades each included 3 students (20%), while the fifth grade had the fewest participants (1 student; 6.7%).</i_keyword>
      <i_keyword>Control group: The control group consisted of 15 students who did not receive any intervention. The largest number of participants were 8-year-olds (5 students, 33.3%). This was followed by 7-year-olds (4 students, 26.7%), 9-year-olds (3 students, 20%), 11-year-olds (2 students, 13.3%), and 10-year-olds (only 1 student, 6.7%).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The study variables included reading performance and executive functions in students with reading disorders. Reading performance encompassed word and nonword reading, reading comprehension, phonological awareness (e.g., phoneme deletion and rhyming), picture naming, word chains, and letter and category identification. Executive functions included inhibition, attention shifting, working memory, planning, emotional control, initiation, organization of materials, and monitoring. Timepoint: The variables were measured using a pretest–posttest design, with assessments conducted before and after the intervention. Method of measurement: The study employed the NEMA test and the Behavior Rating Inventory of Executive Function (BRIEF) to assess reading performance and executive functions, respectively.</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>-</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-07-06</approval_date>
        <contact_name>Research Ethics Committees of Shahid Beheshti University</contact_name>
        <contact_address>No. 10, Alley 606, Fajr 6th Street, Fajr Street Varamin Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
