<?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>IRCT20211004052670N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-10-24</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Comparing the effectiveness of face-to-face and online parent management training classes for parents of children with hyperactivity.</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effectiveness of parent management training sessions through internet based, live, intractive with face-to-face sessions on reducing the symptoms of children with attention deficit hyperactivity disorder.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-09-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>92</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65295</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The method is premature mature block randomization. In this way, first we using online software (sealedenvelope), a sequence of random numbers will be created and by the same software, the generated number will be divided in to 46 block of 2. Which is an equal number in which block will be 1 item from the intervention group and 1 item from control group. So by doing each block, 1 patien (equal) will be assigned to each group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Attention deficit and hyperactivity disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: This group is comprised of parents who attend online classes. The subject of the course would be PMT (parent management training). The six sessions of this course are held once a week. The first session is on children psychology and familiarizing with attention deficit hyperactivity disorder, its etiology, prognosis and treatments. The second session is on commanding. The third one is on strengthening the communication with the child in order to achieve better obedience. The forth and the fifth sessions are about types of encouragement and discipline respectively. The sixth session is on the negative impact of certain situations on child’s misbehavior (e.g., hunger and peer effect). At the beginning of each session, the parents can ask questions about the last sessions and at the end of the session they are guided on specific homework that they are supposed to send to the instructor for review. Intervention 2: Control group: This group is comprised of parents who attend face-to-face classes. The subject of the course would be PMT (parent management training). The six sessions of this course are held once a week. The first session is on children psychology and familiarizing with attention deficit hyperactivity disorder, its etiology, prognosis and treatments. The second session is on commanding. The third one is on strengthening the communication with the child in order to achieve better obedience. The forth and the fifth sessions are about types of encouragement and discipline respectively. The sixth session is on the negative impact of certain situations on child’s misbehavior (e.g., hunger and peer effect). At the beginning of each session, the parents can ask questions about the last sessions and at the end of the session children’s homework is checked.</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 further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Afsane Karbassi Amel</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Khorshid Medical Educational Research Complex ,Isfahan,Iran</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81458-33117</zip>
        <telephone>+98 31 3222 2127</telephone>
        <email>afsaneh_karbasi@med.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Afsane Karbassi Amel</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Khorshid Medical Educational Research Complex ,Isfahan,Iran</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81458-33117</zip>
        <telephone>+98 31 3222 2127</telephone>
        <email>afsaneh_karbasi@med.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Child 3-12 years old
Diagnosis of ADHD according to DSM-V</inclusion_criteria>
      <agemin>3 years</agemin>
      <agemax>12 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Intellectual disability or borderline intelligence
Concomitant physical disorder
Psychological comorbidities
Parents' unwillingness to participate in the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F90</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Attention-deficit hyperactivity disorders</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: This group is comprised of parents who attend online classes. The subject of the course would be PMT (parent management training). The six sessions of this course are held once a week. The first session is on children psychology and familiarizing with attention deficit hyperactivity disorder, its etiology, prognosis and treatments. The second session is on commanding. The third one is on strengthening the communication with the child in order to achieve better obedience. The forth and the fifth sessions are about types of encouragement and discipline respectively. The sixth session is on the negative impact of certain situations on child’s misbehavior (e.g., hunger and peer effect). At the beginning of each session, the parents can ask questions about the last sessions and at the end of the session they are guided on specific homework that they are supposed to send to the instructor for review.</i_keyword>
      <i_keyword>Control group: This group is comprised of parents who attend face-to-face classes. The subject of the course would be PMT (parent management training). The six sessions of this course are held once a week. The first session is on children psychology and familiarizing with attention deficit hyperactivity disorder, its etiology, prognosis and treatments. The second session is on commanding. The third one is on strengthening the communication with the child in order to achieve better obedience. The forth and the fifth sessions are about types of encouragement and discipline respectively. The sixth session is on the negative impact of certain situations on child’s misbehavior (e.g., hunger and peer effect). At the beginning of each session, the parents can ask questions about the last sessions and at the end of the session children’s homework is checked.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Severity of Attention Deficit hyper Activity Disorder. Timepoint: Before the intervention, Immediately after the end of the intervention and tow months after the end of the intervention. Method of measurement: Using Connors 3rd edition and SNAP-IV questionnaires.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Severity of attention deficit hyperactivity disorder. Timepoint: Two months after the end of the sessions. Method of measurement: Using Connors 3rd edition and SNAP-IV questionnaires.</sec_outcome>
      <sec_outcome>Severity of attention deficit. Timepoint: Two months after the end of the sessions. Method of measurement: Using Connors 3rd edition and SNAP-IV questionnaires.</sec_outcome>
      <sec_outcome>Severity of hyperactivity. Timepoint: Two months after the end of the sessions. Method of measurement: Using Connors 3rd edition and SNAP-IV questionnaires.</sec_outcome>
      <sec_outcome>Severity of conduct disorder. Timepoint: Two months after the end of the sessions. Method of measurement: Using Connors 3rd edition and SNAP-IV questionnaires.</sec_outcome>
      <sec_outcome>Severity of social problems. Timepoint: Two months after the end of the sessions. Method of measurement: Using Connors 3rd edition and SNAP-IV questionnaires.</sec_outcome>
      <sec_outcome>Severity of psychosomatic problems. Timepoint: Two months after the end of the sessions. Method of measurement: Using Connors 3rd edition and SNAP-IV questionnaires.</sec_outcome>
      <sec_outcome>Severity of generalized anxiety disorder. Timepoint: Two months after the end of the sessions. Method of measurement: Using Connors 3rd edition and SNAP-IV questionnaires.</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>Isfahan University of Medical Sciences Research Assistant</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-08-14</approval_date>
        <contact_name>Research Research Ethics Committees of School of Medicine - Isfahan University of Medical SciencesRe</contact_name>
        <contact_address>Isfahan, Hazar Jarib Street, Isfahan University of Medical Sciences, Building No. 3, Faculty of Medicine, Ground Floor, Department of Medical Ethics Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
