<?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>IRCT20190813044520N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-04-12</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>The Effectiveness of Hope Therapy on Self-efficacy of Adolescents with Diabetes</public_title>
      <acronym></acronym>
      <scientific_title>The Effectiveness of Group Hope Therapy on Self-efficacy of Adolescents with Type 1 Diabetes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/42351</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: For random allocation of the samples, their names are written on paper cards and then put in a box. The names are then randomly selected by the researcher. The first one is in the experimental group and the second one is in the control group and so on until all of the cards are selected. In this way, participants do not know whether they are in the Experimental or control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Type 1 Diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention group will participant in 8, 90-minute training sessions which is held in educational classes of IERC and based on SHTP 2002. Content is provided by the researcher who has passed a Teaching Hope Therapy program and has a valid degree. Content is performed through lectures, question-and-answer, role-playing and practical home works in group and educating face-to-face using PowerPoint, film, image and then sharing them in a Whats app Group. 1st session: Initial familiarity, articulation of study goals and definition of hope based on Snyder's theory. 2nd session:Explaining how hope develops and its necessity, its effect on hopelessness and feeling of emptiness, the importance of hope in life. 3rd session:Telling the life story of each group members, make them notice their strengths and capability. 4th session:reformatting people's stories based on Snyder's Hope Theory, identifying members' past hopes and successes. 5th session:telling and writing a list of current life events and their important aspects for each member and making them determine their importance and satisfaction. 6th session: Goal setting features  in hopeful people based on Snyder's Hope Theory and encouraging participants to write their own goals. 7th session: The characteristics of appropriate pathways and pathways to goal and ways to increase hope are described. 8th session:there will be an overview chat about interventions and strategies for how to be and stay motivated.At the end of the course, each member will report the home works and share their comments with other members. Intervention 2: Control group:The Control group will have no intervention about hope therapy and they receive only routine diabetes self-care training provided by the center itself.</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 Have not decided yet</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>nasim nikbakhtan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.2, Block.111, 9th entrance, Shahid Montazeri Town, Isfahan</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8161144154</zip>
        <telephone>+98 31 3380 3511</telephone>
        <email>nasim.nikbakhtan@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nasim Nikbakhtan Esfahani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 2, block 111, 9th entrance, Mohammad Montazeri Mini city, Isfahan</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8161144154</zip>
        <telephone>+98 31 3380 3511</telephone>
        <email>nasim.nikbakhtan@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>Type 1 diabetes
The age of 13 to 19 years
At least 6 months passed since diagnosis of type 1 diabetes
The satisfaction of sample subjects and their parents with research participation</inclusion_criteria>
      <agemin>13 years</agemin>
      <agemax>19 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>having other physical illness
having mental illness and crisis and severe mental stress in the past 6 months</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E10</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Type 1 diabetes mellitus</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The intervention group will participant in 8, 90-minute training sessions which is held in educational classes of IERC and based on SHTP 2002. Content is provided by the researcher who has passed a Teaching Hope Therapy program and has a valid degree. Content is performed through lectures, question-and-answer, role-playing and practical home works in group and educating face-to-face using PowerPoint, film, image and then sharing them in a Whats app Group. 1st session: Initial familiarity, articulation of study goals and definition of hope based on Snyder's theory. 2nd session:Explaining how hope develops and its necessity, its effect on hopelessness and feeling of emptiness, the importance of hope in life. 3rd session:Telling the life story of each group members, make them notice their strengths and capability. 4th session:reformatting people's stories based on Snyder's Hope Theory, identifying members' past hopes and successes. 5th session:telling and writing a list of current life events and their important aspects for each member and making them determine their importance and satisfaction. 6th session: Goal setting features  in hopeful people based on Snyder's Hope Theory and encouraging participants to write their own goals. 7th session: The characteristics of appropriate pathways and pathways to goal and ways to increase hope are described. 8th session:there will be an overview chat about interventions and strategies for how to be and stay motivated.At the end of the course, each member will report the home works and share their comments with other members.</i_keyword>
      <i_keyword>Control group:The Control group will have no intervention about hope therapy and they receive only routine diabetes self-care training provided by the center itself.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Self Efficacy Scale measured  by Diabetes Management Self-Efficacy Scale (DMSES) and Self–Efficacy Questionnaire –Children (SEQ-C). Timepoint: before and immediately after the intervention and two months after the intervention. Method of measurement: Diabetes Management Self-Efficacy Scale (DMSES) and Self–Efficacy Questionnaire –Children (SEQ-C).</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>2019-09-17</approval_date>
        <contact_name>Ethic committee of Isfahan University of Medical Science</contact_name>
        <contact_address>Building No. 4, Isfahan University of Medical Science, Hezarjirib Ave., Isfahan Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
