<?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>IRCT20140416017301N9</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-06-24</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Designing Interventions Based on Occupation performance  with facilities learning and its effect on the participation in activities outside of school in students with specific learning disorder</public_title>
      <acronym></acronym>
      <scientific_title>Designing Interventions based on occupation performance coaching with four quadrant model of facilities learning and its effect on the participation in activities outside of school in students with specific learning disorder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-07-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/55842</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Available samples of parents of 7 to 12-year-old students referring to education and rehabilitation centers for special learning problems in Tehran, related to exceptional education (5 areas in Tehran: 1, 6, 8, 14, 18) According to the selected inclusion criteria and after agreeing to participate in this study and signing the consent form, they will be divided into two groups of control and intervention by complete randomization method (sealed envelope method).
In absolute random method (envelope and paper method), the name of groups will be written on a piece of paper and put in an envelope and the participants will be asked to choose one of the papers randomly then the patient will be placed in the intervention or control group, Blinding description: This study is double blind.
Participants (in both intervention and control groups) and the examiner (outcome assessor) are also blind (all assessments at all stages of the study by an experienced occupational therapist working with the child and their family who have previously been tested by the researcher.  They are trained and done completely blind to the type of intervention in each family).
Also, after the interventions in both groups, the test results will be analyzed by a blind statistician from both groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Specific Learning Disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Occupation performance coaching interventions are presented to the intervention group in the form of three areas of structural process, emotional support, and information exchange along with the Four Quadrant Model of Facilitated learning. The content of the sessions based on the inventor of this method and Dr. Kessler, in general, is as follows. Also, the necessary changes will be applied after the pilot phase of the study:                                                                                              Session 1: Introducing and explaining the details of the intervention and setting goals by completing questionnaires (initial assessments). Objectives as specific as possible, measurable, and achievable in 10 to 12 sessions.                                                                                                 Session 2: Start the problem-solving process for one of the goals and provide a printout of the problem-solving process. In this session, the parent determines that he or she will perform at least two different actions during the next week regarding the goal.                               Session 3: Review the first goal and start the next goals (one to two actions for each goal).                                                                         Sessions 4 to 8: Assessing progress in all goals by considering the learning needs of parents and adding the Four Quadrant Model of Facilitated Learning to them to get acquainted with the structure and method of teaching goals to their child.                                                                 session 9: Review of goals and aggregation to end the of sessions.                                                                                                 Session 10 to 12: Deciding on goals that have not been achieved and ending the intervention with completing secondary evaluations. Intervention 2: Control group: Occupation performance coaching interventions are presented to the control group in the form of three areas of structural process, emotional support, and information exchange. The content of the sessions based on the inventor of this method and Dr. Kessler, in general, is as follows. Also, the necessary changes will be applied after the pilot phase of the study:                                                                                   Session 1: Introducing and explaining the details of the intervention and setting goals by completing questionnaires (initial assessments). Objectives as specific as possible, measurable, and achievable in 10 to 12 sessions.                                                                                                 Session 2: Start the problem-solving process for one of the goals set and provide a printout of the problem-solving process. In this session, the parent determines that he or she will perform at least two different actions regarding the goal in the coming week.                                  Session 3: Review the first goal and start the next goals (one to two actions for each goal).                                                                         Sessions 4 to 8: Examining progress on all goals.                              Session 9: Review of goals and aggregation to end of sessions.                                                                                                  Session 10 to 12: Deciding on goals that have not been achieved and ending the intervention with completing secondary evaluations.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Akram Azad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mirdamad Blv., Modar Sq., Shahnazari Ave., School of Rehabilitation</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1545913187</zip>
        <telephone>+98 21 2222 8051</telephone>
        <email>azad.a@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Akram Azad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mirdamad Ave, Modar Blvd, Nazari St, School of Rehabilition</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>154513187</zip>
        <telephone>+98 21 2222 8051</telephone>
        <email>azad.a@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The age of the student is between 7 and 12 years (both sexes)
The participating families must live in Tehran
The student has a diagnosis of a specific learning disorder. Diagnosis is made by experts from Exceptional Education Learning Disabilities Centers through the Wechsler Intelligence Test for Children, the Stanford-Binet Intelligence Test and the Woodcock Johnson Cognitive Ability Test.
The student has no physical, vision or hearing problems;
The student should not have comorbidities such as Coping Behavior Disorder, Disruptive Disorders, Disseminated anxiety disorder, Depressive disorder, Separation Anxiety Disorder, and Social phobia through the Child Symptoms Questionnaire (CSI-4).
The participating parent must have a diploma or higher</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Parents cancel their cooperation in answering the questionnaires or referring to the intervention sessions;
Parent's unwillingness to participate in intervention sessions or answering a questionnaire;
Occurrence of problems, illnesses, life changes or events for the parent that affect the behaviors being evaluated or seriously affect the results of the study.
Lack of severe depression for the participating parent based on the Depression, Anxiety, and Stress Scale-21(DASS-21)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F81</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Specific developmental disorders of scholastic skills</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Occupation performance coaching interventions are presented to the intervention group in the form of three areas of structural process, emotional support, and information exchange along with the Four Quadrant Model of Facilitated learning. The content of the sessions based on the inventor of this method and Dr. Kessler, in general, is as follows. Also, the necessary changes will be applied after the pilot phase of the study:                                                                                              Session 1: Introducing and explaining the details of the intervention and setting goals by completing questionnaires (initial assessments). Objectives as specific as possible, measurable, and achievable in 10 to 12 sessions.                                                                                                 Session 2: Start the problem-solving process for one of the goals and provide a printout of the problem-solving process. In this session, the parent determines that he or she will perform at least two different actions during the next week regarding the goal.                               Session 3: Review the first goal and start the next goals (one to two actions for each goal).                                                                         Sessions 4 to 8: Assessing progress in all goals by considering the learning needs of parents and adding the Four Quadrant Model of Facilitated Learning to them to get acquainted with the structure and method of teaching goals to their child.                                                                 session 9: Review of goals and aggregation to end the of sessions.                                                                                                 Session 10 to 12: Deciding on goals that have not been achieved and ending the intervention with completing secondary evaluations</i_keyword>
      <i_keyword>Control group: Occupation performance coaching interventions are presented to the control group in the form of three areas of structural process, emotional support, and information exchange. The content of the sessions based on the inventor of this method and Dr. Kessler, in general, is as follows. Also, the necessary changes will be applied after the pilot phase of the study:                                                                                   Session 1: Introducing and explaining the details of the intervention and setting goals by completing questionnaires (initial assessments). Objectives as specific as possible, measurable, and achievable in 10 to 12 sessions.                                                                                                 Session 2: Start the problem-solving process for one of the goals set and provide a printout of the problem-solving process. In this session, the parent determines that he or she will perform at least two different actions regarding the goal in the coming week.                                  Session 3: Review the first goal and start the next goals (one to two actions for each goal).                                                                         Sessions 4 to 8: Examining progress on all goals.                              Session 9: Review of goals and aggregation to end of sessions.                                                                                                  Session 10 to 12: Deciding on goals that have not been achieved and ending the intervention with completing secondary evaluations</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Participate in extracurricular activities including basic activities of daily living, instrumental activities of daily living, play, leisure, social participation and sleep performance. Timepoint: Before intervention, after intervention , follow up after 1/5 month of intervention. Method of measurement: Children Participation Assessment Scale -Parent Version (CPAS-P).</prim_outcome>
      <prim_outcome>The quality of student performance in the priorities set by the family. Timepoint: Before intervention, after intervention , follow up after 1/5 month of intervention. Method of measurement: Canadian Occupational Performance Measure (COPM).</prim_outcome>
      <prim_outcome>Degree of family satisfaction with the child's performance. Timepoint: Before intervention, after intervention , follow up after 1/5 month of intervention. Method of measurement: Canadian Occupational Performance Measure (COPM).</prim_outcome>
      <prim_outcome>Rate of achievement of goals set by the family. Timepoint: Before intervention, after intervention , follow up after 1/5 month of intervention. Method of measurement: Goal Attainment Scale (GAS).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Student's educational status (grades obtained in school, which are obtained by the student and entered in the school transcript). Timepoint: Before intervention, after intervention , follow up after 1/5 month of intervention. Method of measurement: Shades of Academic Adequacy of the Ministry of Education.</sec_outcome>
      <sec_outcome>Executive functions include two parts: behavior regulation index (inhibit, shift, emotional control) and metacognition index (working memory, initiation, plan, organization of materials, monitor). Timepoint: Before intervention, after intervention , follow up after 1/5 month of intervention. Method of measurement: Behavior Rating Inventory of Executive Function (BRIEF).</sec_outcome>
      <sec_outcome>Self-efficacy of parent. Timepoint: Before intervention, after intervention , follow up after 1/5 month of intervention. Method of measurement: The Sherer General Self-Efficacy Scale (SGSES).</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>2021-04-18</approval_date>
        <contact_name>Ethics committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Shahid Hemmat Highway between Sheikh Fazl ... Nouri and Shahid Chamran Iran University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
