<?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>IRCT20130422013092N11</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-09-16</date_registration>
      <primary_sponsor>Boushehr University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Education Based on Self-Management Empowerment Model on the Sense of Coherence, Coping Strategies and Self-Efficacy of Girl Adolescents with Internet Addiction</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Education Based on Self-Management Empowerment Model on the Sense of Coherence, Coping Strategies and Self-Efficacy of Girl Adolescents with Internet Addiction</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-10-08</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65359</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The researcher will select and refer to two non-profit girls' schools and two public girls' schools of the first year of secondary school as a simple random sampling. The sample size includes 80 people, 20 people will be selected from each school. Based on the list of class names, the Internet addiction questionnaire is provided to the teenager to complete it. The completion of the questionnaire is continued by 3 levels until finally 20 people from each school whose score of internet addiction is medium to high are selected and assigned to two test and control groups based on the random numbers of the Excel software. In order to prevent the exchange of information between the two groups, there will be a public school in the test group and a public school in the control group, as well as a non-profit school in the test group and a non-profit school in the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Internet Addiction.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: After obtaining written consent from all the participants and completing the demographic information questionnaire, Antonovski's sense of coherence questionnaire, Endler and Parker's coping with stressful situations questionnaire and Scherer's general self-efficacy questionnaire will be completed. In the intervention group, strategies for empowering teenagers with Internet addiction in 3 areas of sense of coherence, coping strategies and self-efficacy will be carried out according to the self-management empowerment model in 5 steps. In such a way that the solutions depend on the conditions and needs of the teenager with internet addiction, in the form of face-to-face and individual interviews for two weeks, two 45-minute sessions are implemented every week, then the training booklet will be presented to the teenager, and after During this period, counseling and follow-up will be provided through phone calls for 6 weeks, and the proposed programs will be implemented for two months. For teenagers in the intervention group, self-management empowerment program training that includes the structural concepts of self-awareness of changes, independence, role function, adaptability, perceived satisfaction, sense of control and self-management will be implemented. The intervention will be implemented for 8 weeks in the intervention group. After two months, Antonovsky's sense of coherence questionnaire, Endler and Parker's coping with stressful situations questionnaire and Scherer's general self-efficacy questionnaire will be completed again by the intervention and control groups. Intervention 2: Control group: Without the intervention.</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 -</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Somaye Bashirinia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>bushehr. sabzabad. next salman farsi hospital. bushehr university of medical sciences</address>
        <city>Bushehr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7518759338</zip>
        <telephone>-</telephone>
        <email>somayebashirinia@gmail.com</email>
        <affiliation>Boushehr University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Ravanipour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Busher, Sabzabad, next Salman Ffarsi hospital, Bushehr University of Medical Sciences</address>
        <city>Bushehr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>-</zip>
        <telephone>+98 77 3345 0187</telephone>
        <email>ravanipour@bpums.ac.ir</email>
        <affiliation>Boushehr University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Being between 12-14 years old
Studied in Bushehr high schools
Having a moderate to high internet addiction score
Having a device to connect to the Internet such as a smartphone
Willingness and consent of the teenager and his parents to participate in the study</inclusion_criteria>
      <agemin>12 years</agemin>
      <agemax>14 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Having a known mental illness and taking psychiatric drugs affecting behavior and speech; Participation in other similar research.</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>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: After obtaining written consent from all the participants and completing the demographic information questionnaire, Antonovski's sense of coherence questionnaire, Endler and Parker's coping with stressful situations questionnaire and Scherer's general self-efficacy questionnaire will be completed. In the intervention group, strategies for empowering teenagers with Internet addiction in 3 areas of sense of coherence, coping strategies and self-efficacy will be carried out according to the self-management empowerment model in 5 steps. In such a way that the solutions depend on the conditions and needs of the teenager with internet addiction, in the form of face-to-face and individual interviews for two weeks, two 45-minute sessions are implemented every week, then the training booklet will be presented to the teenager, and after During this period, counseling and follow-up will be provided through phone calls for 6 weeks, and the proposed programs will be implemented for two months. For teenagers in the intervention group, self-management empowerment program training that includes the structural concepts of self-awareness of changes, independence, role function, adaptability, perceived satisfaction, sense of control and self-management will be implemented. The intervention will be implemented for 8 weeks in the intervention group. After two months, Antonovsky's sense of coherence questionnaire, Endler and Parker's coping with stressful situations questionnaire and Scherer's general self-efficacy questionnaire will be completed again by the intervention and control groups.</i_keyword>
      <i_keyword>Control group: Without the intervention</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Attainment to sense of coherence. Timepoint: Before intervention، 2 month after intervention. Method of measurement: Antonovsky sense of coherence questionnaire.</prim_outcome>
      <prim_outcome>Attainment to Self Efficacy. Timepoint: En before intervention، 2 month after intervention. Method of measurement: Scherer General Self-Efficacy Questionnaire.</prim_outcome>
      <prim_outcome>Attainment to problem-oriented coping strategies. Timepoint: En before intervention، 2 month after intervention. Method of measurement: Endler and Parker coping with stressful situations questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Achieving proper management in using the Internet. Timepoint: before intervention. Method of measurement: Young's Internet Addiction Questionnaire.</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>Boushehr University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-09-14</approval_date>
        <contact_name>Resercher assistence Bushehr University of Medical Sciences</contact_name>
        <contact_address>Busher, Sabzabad, next Salman Ffarsi hospital, Bushehr University of Medical Sciences Bushehr Boushehr Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
