<?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>IRCT20220708055417N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-09-11</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Investigating the Effect of Educational Training of Intellectually Disabled Children on Their Parents</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Educational Training on Mentally Retarded Children to Reduce the Burden of Caring for Their Parents</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-08-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64806</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this research, it is a semi-experimental type of research, and the sampling method in this research is selected in the available way and assigned in a simple random way.  In such a way that all the members of the statistical community will have an equal chance to be selected, this selection is done using the lottery method.  In this way, the numbers of each of these beneficiaries are put in a bag and then they are taken out one by one until the desired number of the sample is obtained. The sample size in this research will include 30 people who will be randomly divided into two groups of 15 people.  and will be used randomly in such a way that one group will be selected as the experimental group and one group will be selected as the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>The Effectiveness of Academic training educable mentally retarded children in reducing the burden of caring for their parents.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: intervention will takes place in an educational and rehabilitation center in Pakdasht city according to an educational protocol including basic and preliminary education including: familiarization with the surrounding environment, instructor and classmates for two to five days, individual skills training for one to six months, skills training  Social manners one to three months, training to increase accuracy and attention and concentration and eye and hand coordination six months to one year, color training two months to one year, calligraphy and painting training six months to one year, memory strengthening training six months to  One year, math training takes six months to one year and physical and mental training for one year. Intervention 2: Control group: no intervention is done for the control group. Before the intervention a Pre-test was taken from the control group and they were put on the waiting list. At the end of the intervention, they will be given a post- test and the result will be analyzed.</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>Elahe Dolatabadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>3rd floor, No. 5, Fadak 3 alley, 20 Meteri Meqdad</address>
        <city>Pakdasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3391845775</zip>
        <telephone>+98 21 3603 4379</telephone>
        <email>mohamadmahdi9566@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Elahe Dolatabadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>3rd floor, No. 5, Fadak 3 alley, 20 Meteri Meqdad</address>
        <city>Pakdasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3391845775</zip>
        <telephone>+98 21 3603 4379</telephone>
        <email>mohamadmahdi9566@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Filling the informed consent form to participate in research therapy sessions
Having the cooperation of people in completing the questionnaires
Boys and girls under the age of 14 years old with mental retardation
Not having vision and hearing problems
Not having autism and hyperactivity disorder
Parents participating in the research therapy sessions not being treated by a psychiatrist or a clinical psychologist</inclusion_criteria>
      <agemin>6 years</agemin>
      <agemax>14 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Children whose intellectual performance level is not trainable, for example trainable, supportable, borderline, etc
Parents who have more than one mentally retarded child</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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: intervention will takes place in an educational and rehabilitation center in Pakdasht city according to an educational protocol including basic and preliminary education including: familiarization with the surrounding environment, instructor and classmates for two to five days, individual skills training for one to six months, skills training  Social manners one to three months, training to increase accuracy and attention and concentration and eye and hand coordination six months to one year, color training two months to one year, calligraphy and painting training six months to one year, memory strengthening training six months to  One year, math training takes six months to one year and physical and mental training for one year.</i_keyword>
      <i_keyword>Control group: no intervention is done for the control group. Before the intervention a Pre-test was taken from the control group and they were put on the waiting list. At the end of the intervention, they will be given a post- test and the result will be analyzed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Percentage of care burden pressure of parents with mentally retarded children. Timepoint: Measurement of parental care burden after 1 month and 2 months. Method of measurement: Questionnaire of Zarit et al.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The score of reduction of care burden pressures of parents with mentally retarded children. Timepoint: Measuring the care burden of parents with mentally retarded children after 1 month and 2 months. Method of measurement: Questionnaire of Zarit et al.</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-06-22</approval_date>
        <contact_name>Ethics Committee of Islamic Azad University, Semnan branch</contact_name>
        <contact_address>Islamic Azad University Semnan branch, Shahrak Daneshgahi, Semnan Semnan Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
