<?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>IRCT20200207046403N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-02-22</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of an educational plan on the internet addiction adolescent girls</public_title>
      <acronym></acronym>
      <scientific_title>The effect of an educational plan on the internet addiction of high-school adolescent girls in Isfahan,1398</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-02-29</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>54</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/45613</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Simple Random allocation Method: Random allocation will place a school in the test group and a school in the control group By throwing a coin.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Internet Addiction.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: At least one class will be randomly assigned to each intervention school in the intervention school. Then the class students will talk about the research objectives and the questionnaires will be provided with the consent of all students in the study and a number will be given to each student. The participants will complete the questionnaire. After statistical analysis, the participants were selected by simple random sampling. Planning and coordination with the school administrator will be performed prior to the intervention to select the appropriate place for training and to determine the timing of classes. It is also required that one of the parents of the student sign the consent form to participate in the research, and during the phone call to confirm consent with the parent, the student will be given the consent form and the researcher will be provided with the researcher number. And if the student is absent at each meeting, parents will be contacted for coordination and information. There will be eight 45-minute training sessions for the test group. The researcher, citing articles and authoritative books, provides the necessary training to reduce internet addiction, with the content of time management and controlling factors leading to Internet use, with a look at cognitive-behavioral therapy. Meetings are held at the school in coordination with the principal and the relevant authorities in non-classroom time with similar educational conditions. Questionnaires will be completed again by the participants two weeks after the last session. Then the data will be analyzed using SPSS software version 26 and related statistical tests. Intervention 2: Control group: 1016/5000At least one classroom will be randomly assigned from each educational base at the same time as the intervention group begins sampling. Then, the class students will discuss the research objectives and the questionnaires will be provided with the consent of all students in the study and a number will be given to each student. The sample will complete the questionnaires and the consent form. After statistical analysis, the participants who were selected for the study with a score of 49 on the Young Internet Addiction Questionnaire were selected by simple random sampling. They will then be given a written consent to provide the parents with a signature and then hand over to the school nurturer. There is no intervention in this group and people will have their daily activities. Questionnaires will be filled out by the participants at the end of the intervention group as the sample is completed. To comply with ethical standards, individuals in this group may participate in meetings that are held after the intervention if the study is effective and willing.</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:
Total personal data after being unrecognized and data on internet addiction and parent-child relationship

When:
Start of 6 month access period after printing results

To whom:
Researchers working in scientific institutes

Conditions:
There are no special conditions.

Where to obtain:
f.joonbakhsh@nm.mui.ac.ir

How to obtain:
The email will first be sent to the request, and after reviewing the request, the response and the data will be provided.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Joonbakhsh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Room158, faculty of nursing, Isfahan university of medical sciences,Sofeh Blvd,Isfahan</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8179935637</zip>
        <telephone>+98 31 3792 7576</telephone>
        <email>f.joonbakhsh@nm.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Joonbakhsh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Room158, faculty of nursing, Isfahan university of medical sciences,Sofeh Blvd,Isfahan</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8179935637</zip>
        <telephone>+98 31 3792 7576</telephone>
        <email>f.joonbakhsh@nm.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Adolescent girls between 14 and 18 years
Individuals who are attending public secondary schools in Isfahan
The student has Internet access
Their Internet addiction score is over 49 according to the Yang questionnaire
Participants should not be diagnosed with psychiatric illness and not undergo drug therapy
Adolescents and their parents' satisfaction  and permission with research</inclusion_criteria>
      <agemin>14 years</agemin>
      <agemax>18 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Adolescent and their parents' dissatisfaction with research
Drug-related psychiatric illness
Yang Internet Addiction Questionnaire score less than 49
Lack of Internet access for any reason</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: At least one class will be randomly assigned to each intervention school in the intervention school. Then the class students will talk about the research objectives and the questionnaires will be provided with the consent of all students in the study and a number will be given to each student. The participants will complete the questionnaire. After statistical analysis, the participants were selected by simple random sampling. Planning and coordination with the school administrator will be performed prior to the intervention to select the appropriate place for training and to determine the timing of classes. It is also required that one of the parents of the student sign the consent form to participate in the research, and during the phone call to confirm consent with the parent, the student will be given the consent form and the researcher will be provided with the researcher number. And if the student is absent at each meeting, parents will be contacted for coordination and information. There will be eight 45-minute training sessions for the test group. The researcher, citing articles and authoritative books, provides the necessary training to reduce internet addiction, with the content of time management and controlling factors leading to Internet use, with a look at cognitive-behavioral therapy. Meetings are held at the school in coordination with the principal and the relevant authorities in non-classroom time with similar educational conditions. Questionnaires will be completed again by the participants two weeks after the last session. Then the data will be analyzed using SPSS software version 26 and related statistical tests.</i_keyword>
      <i_keyword>Control group: 1016/5000At least one classroom will be randomly assigned from each educational base at the same time as the intervention group begins sampling. Then, the class students will discuss the research objectives and the questionnaires will be provided with the consent of all students in the study and a number will be given to each student. The sample will complete the questionnaires and the consent form. After statistical analysis, the participants who were selected for the study with a score of 49 on the Young Internet Addiction Questionnaire were selected by simple random sampling. They will then be given a written consent to provide the parents with a signature and then hand over to the school nurturer. There is no intervention in this group and people will have their daily activities. Questionnaires will be filled out by the participants at the end of the intervention group as the sample is completed. To comply with ethical standards, individuals in this group may participate in meetings that are held after the intervention if the study is effective and willing.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The percentage of people with a Yang Internet Addiction Questionnaire score is over 49. Timepoint: Before intervention and 2 weeks after educational intervention. Method of measurement: Yang Internet Addiction Questionnaire.</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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-10-23</approval_date>
        <contact_name>Ethics committee of Esfahan University of Medical Sciences</contact_name>
        <contact_address>Isfahan University of Medical Sciences,Hezar Jerib Street Esfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
