<?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>IRCT20180209038675N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-04-03</date_registration>
      <primary_sponsor>Shahroud University of Medical Sciences</primary_sponsor>
      <public_title>Evaluating the effectiveness of puberty education for adolescents</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effectiveness of two methods of motivational interviewing and use of peer group in promoting puberty health in adolescent girls</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-04-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/29926</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Randomization is simple in the first step. Schools are non-profit based, located in the center of the city and in the margin of the city are divided into 3 classes or groups. The school is considered as a cluster on each floor. In each class, the school is randomized. Of any homogeneous group, schools are selected randomly. In each school, a class is randomly selected as a simple one. Sampling continues to the limit. Then, selected schools of each class are randomly selected and created in 3 groups: Group A, B, and C. After completing the pre-test, groups A, B, and C are randomly assigned to peer groups for control, motivational interviewing and training, Blinding description: All the participants in the study announced that there are three groups and they are randomly assigned to a specific group. In order to prevent leakage of information from groups, there is only one group in each school (intervention 1, intervention 2 or control). Also, to blind the person collecting the information, another person who is not informed to the group is used to fill in the questionnaires after the intervention in two groups. Also, the person who analysis the data, does not know the group of people.</study_design>
      <phase>N/A</phase>
      <hc_freetext>puberty health.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: To conduct motivational interviewing sessions to improve the puberty health of girls' at intervals of one week and 5 sessions 60 minutes. The day of the meetings is discussed with the participants beforehand and will be served after the meeting. Intervention 2: Intervention Group 2: In this group, peer educators will be selected by students with conditions such as higher score in the puberty health questionnaire than others, approved by the school administrator and teachers. Elderly peers see a training session by the researcher on puberty health behaviors and then they will be given a pamphlet of the same material to remind them. Then, one session will be held to introduce peer educators to others and a brief explanation of their puberty health by the presence of a researcher in the classroom. Continuing education is informal and can provide training in any environment. 1 month is given to peer educators to transfer information to others. Intervention 3: Control group: This group does not receive any counseling and training until the end of the interventions. However, in order to observe ethical issues after completing the interventions and completing post tests, two educational sessions will be held with the content of puberty health and to promote puberty health by the researcher for this group.</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 Due to the implementation of the analysis on the data and questionnaires, and considering that the final results will be published in the form of the paper, then, after consultation with the discretion of the supervisors and counselors, we will take action.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sarah Mohamadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>7 Tir Square, Shahroud University of Medical Sciences</address>
        <city>Shahroud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۳۶۱۴۷-۷۳۹۴۷</zip>
        <telephone>+98 23 3239 5054</telephone>
        <email>sarah.mohamadi.1994@gmail.com</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Motaghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>7 Tir Square, Shahroud University of Medical Sciences</address>
        <city>Shahroud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۳۶۱۴۷-۷۳۹۴۷</zip>
        <telephone>+98 23 3239 5054</telephone>
        <email>zhrmotaghi@yahoo.com</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Iranian girls
without a specific disease
without mental and Psychiatry disorders
negative history for using psychiatric drugs
Not having restrictions on attending meetings
Non-attendance at similar classes outside of school-
Not having a loved one's death or a tense incident for at least the past 3 months
The desire of teenagers and parents to participate in the study and fill out a form of informed consent by them
11-16 years old adoescents</inclusion_criteria>
      <agemin>11 years</agemin>
      <agemax>16 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></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>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: To conduct motivational interviewing sessions to improve the puberty health of girls' at intervals of one week and 5 sessions 60 minutes. The day of the meetings is discussed with the participants beforehand and will be served after the meeting.</i_keyword>
      <i_keyword>Intervention Group 2: In this group, peer educators will be selected by students with conditions such as higher score in the puberty health questionnaire than others, approved by the school administrator and teachers. Elderly peers see a training session by the researcher on puberty health behaviors and then they will be given a pamphlet of the same material to remind them. Then, one session will be held to introduce peer educators to others and a brief explanation of their puberty health by the presence of a researcher in the classroom. Continuing education is informal and can provide training in any environment. 1 month is given to peer educators to transfer information to others.</i_keyword>
      <i_keyword>Control group: This group does not receive any counseling and training until the end of the interventions. However, in order to observe ethical issues after completing the interventions and completing post tests, two educational sessions will be held with the content of puberty health and to promote puberty health by the researcher for this group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Puberty Health Questionnaire. Timepoint: Evaluation of puberty health before the intervention - immediately after the intervention and one month after the intervention was completed. Method of measurement: puberty Health 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>Shahroud University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-12-20</approval_date>
        <contact_name>Ethics committee of Shahroud University of Medical Sciences</contact_name>
        <contact_address>7 Tir Square, Shahroud University of Medical Sciences Shahroud Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
