<?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>IRCT2016100330116N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-07-03</date_registration>
      <primary_sponsor>  Research assistance of Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Sexual health education to mothers who have 12-14 years old sons.</public_title>
      <acronym>With a random start, based on the list students in the class (Close your eyes and put a finger with</acronym>
      <scientific_title>Comparing the effect of group education and multimedia software on  knowledge, attitude and self-efficacy mothers about of sexual health education to the boys of between 12-14 years old</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-09-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>108</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/24033</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: Quite randomly (Closing eyes and putting the finger on numbers) the participants will be selected; 11 Persons in the multimedia group; 11 Persons in the training group and 11 Persons in the control group will be randomly assigned into blocks with size of 3. All modes of possibilities     will be considered to have 3 people equally into three groups of A, B and C. then, R will be employed to randomly select 11 blocks for each school. The lists for each school has been prepared and accordingly participants will be grouped.</study_design>
      <phase>N/A</phase>
      <hc_freetext>mother Knowledge, attitude and self-efficacy about sexual health education of boys 14-12 year old.</hc_freetext>
      <i_freetext>Intervention 1: The control group will be not received any training and only will be participated in the pre-test and post-test. Intervention 2: For group Multimedia, 4 CDs will be designed and every week 1 CD-ROM will be put available to them. The first session; CD 1 (videos, animations, audio and text) regarding relationships with teens (45 min) will be handed to mothers, and explanations about how to use it will be provided. Then, three days later the participants will be called to make sure they have watched the CD, and will be asked to refer to the research center to get another CD. This procedure will be repeated for the next discs (CD2, maturity; CD3, sexual behavior; CD4, sexual health). At the end of the fourth week, the intervention group will be gather at school and question and answer session will be run  for 60 minutes. Mothers will be asked to  speak about to issues of CDs with his children and 15 days later the post-test will be administered. Intervention 3: Group trainings sessions  will be held once per week. Each group will be consisted of 11-10 people and four 60-minute sessions  will be considered with the content of sexual health education (relationship with teens; maturity; Sexual behavior and sexual health) that will be included in CDs. Researcher will be handed all the materials to the mothers by  PowerPoint presentations; lectures (45 minutes); question and answer (15 minutes). Mothers  will be asked to speak about to issues of CDs with their sons and 15 days later post-tests will be held.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Khadijeh Mirzaii</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Ebne Sina Street, ِDoktora Crossroads,ِ Daneshgah Avenue</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51385915113</telephone>
        <email>k.mirzaii@gmail.com</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr khadijeh Mirzaii</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Ebne Sina Street, ِDoktora Crossroads,ِ Daneshgah Avenue</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51385915113</telephone>
        <email>k.mirzaii@gmail.com</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Entrance criteria at the beginning of the study: being Iranian; living in  Mashhad ; younger than 50; able to read and write; computer accessibility and literacy; physically healthy; living with their husbands; having a 12-14 year-old son who is studying at the first level of high school. Exclusion criteria are: addiction to Smoking and alcohol; her son has been affected by sexual problems so far; have given sexual trainings to their sons, have observed such CDs in the field of sexual health working as staff of Health System or graduates of  Medical Sciences, Psychology or Counseling; now suffering from mental illness or having a history of being hospitalized in the hospital due to mental health problems or taking drugs such as imipramine, diazepam, phenobarbital, chlordiazepoxide; during the 6 months ago unfortunate incident and severe stress is not occurred; The questionnaire score for DASS 21 ( Depression scale) is over 21; The questionnaire score for the subsection of Anxiety scale is over 15; The questionnaire score for the subsection of Stress scale is over 26. &#13;
Exclusion criteria during the study: More than a tablet is not observed; more than one meeting is absent; during the study, adverse events and stressful happened to them.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>45 years</agemax>
      <gender>Both</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>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The control group will be not received any training and only will be participated in the pre-test and post-test.</i_keyword>
      <i_keyword>For group Multimedia, 4 CDs will be designed and every week 1 CD-ROM will be put available to them. The first session; CD 1 (videos, animations, audio and text) regarding relationships with teens (45 min) will be handed to mothers, and explanations about how to use it will be provided. Then, three days later the participants will be called to make sure they have watched the CD, and will be asked to refer to the research center to get another CD. This procedure will be repeated for the next discs (CD2, maturity; CD3, sexual behavior; CD4, sexual health). At the end of the fourth week, the intervention group will be gather at school and question and answer session will be run  for 60 minutes. Mothers will be asked to  speak about to issues of CDs with his children and 15 days later the post-test will be administered.</i_keyword>
      <i_keyword>Group trainings sessions  will be held once per week. Each group will be consisted of 11-10 people and four 60-minute sessions  will be considered with the content of sexual health education (relationship with teens; maturity; Sexual behavior and sexual health) that will be included in CDs. Researcher will be handed all the materials to the mothers by  PowerPoint presentations; lectures (45 minutes); question and answer (15 minutes). Mothers  will be asked to speak about to issues of CDs with their sons and 15 days later post-tests will be held.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Knowledge. Timepoint: Before and two weeks after the intervention. Method of measurement: Questionnaire Self-made.</prim_outcome>
      <prim_outcome>Attitude. Timepoint: Before and two weeks after the intervention. Method of measurement: Questionnaire Self-made.</prim_outcome>
      <prim_outcome>Self-efficacy. Timepoint: Before and two weeks after the intervention. Method of measurement: Questionnaire Self-made.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Knowledge boys. Timepoint: Before and two weeks after the intervention. Method of measurement: questionnaire   Self-made.</sec_outcome>
      <sec_outcome>Attitude boys. Timepoint: Before and two weeks after the intervention. Method of measurement: questionnaire   Self-made.</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>  Research assistance of Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-06-11</approval_date>
        <contact_name>Ethics committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Daneshgah Avenue, Doktora Crossroads, Ebne sina St, School of Nursing and Midwifery Mashhad  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
