<?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>IRCT20231118060101N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-12-12</date_registration>
      <primary_sponsor>institute for cognitive science studies</primary_sponsor>
      <public_title>The Intervention of Music-Based Education on Executive Functions in High-Functioning Children with Autism</public_title>
      <acronym></acronym>
      <scientific_title>The Intervention of Music-Based Education on Executive Functions in High-Functioning Children with Autism</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-01-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>35</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/73838</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Single, Purpose: Education/Guidance, Other design features: For Each Session There Is A Curriculum And Execution Order That Is Tailored To The Development Of Executive Functions Such As: Flexibility, Working Memory, And Planning With Musical Instruments, Randomization description: After Collecting the Sample Size Required for the Study, the Samples Were Matched Peer-to-Peer Based on Gender and Age, and Then Randomly Assigned into Two Control and Test Groups, Blinding description: In The Call For Participation In This Research Project, Families Interested In Enrolling Their Children In Music Education Classes Were Invited. It Was Stated That If Certain Criteria Were Present In Their Children, The Entire Cost Of The Classes Would Be Provided Free Of Charge For A Period Of Three Months. These Criteria Were Obtained From Participants Through An Initial Assessment Session Involving Computerized Tests To Measure Executive Functions, And Those Who Met The Criteria For Entry Into The Research Were Invited To Participate.

For This Purpose, A Music Education Coach Was Recruited, Intending To Conduct A Charitable Act By Offering Free Music Education Classes For Children With Autism. In These Classes, Only A Structured Music Education Program With A Lesson Plan And Implementation Guidelines Should Be Taught For 12 One-Hour Private Sessions With Individuals Affected By Autism.</study_design>
      <phase>N/A</phase>
      <hc_freetext>the high functioning children with autism.</hc_freetext>
      <i_freetext>Intervention 1: Intervention Group: 12 one-hour music education sessions per week, each session with a predetermined lesson plan executed by the instructor. Intervention 2: Control group: The Control Group Is to Measure Placebo Effect and Familiarization Error Through Pre-test.</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:
ما انتظار داریم که پس از پایان مطالعه ، داده های شرکت کنندگان به روشی غیرقابل شناسایی منتشر شود.

When:
Data will be made available immediately after the paper is printed

To whom:
All interested persons will have the possibility to access the data.

Conditions:
No limitation will notice the use of the data obtained from the data of this study for those interested in using the scientific data of this study.
And to develop and promote scientific achievements to make the most of this finding, this information and documentation are accessible.

Where to obtain:
In scientific databases, this information can be obtained or if requested by email to the author in charge. Email: hadi_st222@yahoo.com

How to obtain:
The applicant should send the author an email with the data of the study and receive the information they need.
The author in charge is obliged to make the information required and research findings available to other researchers as soon as possible after seeing the applicant's email

Comments:
The research information will be coded and referred to as online links on the internet platform from within the extracted article.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hadi Sarmast</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 19, Boston 5, 30 metry valiasr, salehiyeh, baharestan</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3113145798</zip>
        <telephone>+98 21 5662 1974</telephone>
        <email>hadi_st222@yahoo.com</email>
        <affiliation>Institute for cognitive science studies</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hadi Sarmast</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 19, Boston 5, 30 metry valiasr, salehiyeh, baharestan</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3113145798</zip>
        <telephone>+98 21 5662 1974</telephone>
        <email>hadi_st222@yahoo.com</email>
        <affiliation>Institute for cognitive science studies</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosis of High-Functioning Autism Spectrum from a Pediatric Psychiatrist or Neurologist
Children Should Not Have Any Background in Music Education.
Children Should Not Have Attention Deficit Hyperactivity Disorder
Children Should Not Have Movement Restrictions on the Movement of the Fingers in a Way That Leads to Restrictions on Playing the Piano Instrument</inclusion_criteria>
      <agemin>7 years</agemin>
      <agemax>15 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Diagnosis of ADHD
The Presence of Severe Mental and/or Physical Illnesses.
Absence of More Than Two Sessions in the Music Education Program.
Educational and Therapeutic Intervention Related to the Objectives of the Present Research During the Course of Music Education.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F84.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Autistic disorder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention Group: 12 one-hour music education sessions per week, each session with a predetermined lesson plan executed by the instructor.</i_keyword>
      <i_keyword>Control group: The Control Group Is to Measure Placebo Effect and Familiarization Error Through Pre-test</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Executive functions. Timepoint: Once before music education and the time immediately after 12 music education sessions. Method of measurement: Software version of executive functions by gaming with laptop and measuring the duration and variables studied for each executive function.</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>institute for cognitive science studies</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-12-08</approval_date>
        <contact_name>ethics committee of institute for cognitive science studies</contact_name>
        <contact_address>Phase 4 of Pardis City, Tehran, Iran pardis Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
