<?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>IRCT20120609009975N10</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-09-09</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The Effect Of Child Sexual Abuse Prevention Program On Student’s Awareness And Protective Skills: A Comparison Of Teachers And Parents As Instructors</public_title>
      <acronym></acronym>
      <scientific_title>The Effect Of Child Sexual Abuse Prevention Program On Student’s Awareness And Protective Skills: A Comparison Of Teachers And Parents As Instructors</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-10-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>160</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/54821</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: In order to do this research, a small town named Mallard, divided into two parts based on the economic and social level. All primary schools are listed, and then from each part, a governmental girls' primary school and a boys' primary school will be selected by simple randomization by random lottery (overall four primary schools).  These four schools will consider as the cluster. From the list of the third-grade classes in each school, one class is set as intervention group 1 and one class at intervention class 2 randomly. So the students in one class will be trained by the teacher and the other class by their parents.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Child Sexual Abuse.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Students who will receive training from their teachers will be in the first intervention group.   To unify the education, the researcher will provide the necessary training about child sexual abuse to teachers and parents simultaneously, in the form of 4  weekly training sessions of 50 minutes. In the first session, the content includes the definition, types, prevalence, complications, risk factors, possible physical, psychological and social symptoms of the child victim, evidence on the impact of education on prevention, barriers for parents and teachers to talk to children, potential benefits and harms. It will be about CSA. In the second session, the concepts of body ownership, private parts of the body, the concept of privacy, defining the trust circle, and how to report suspicious cases will be taught. The content of the third session will include recognizing good and bad touches, distinguishing between right and wrong, the four skills of saying no, leaving the place, the need to report, specifying the list of trusted people to report, and how to report. The content of the fourth session includes ensuring part of the child's innocence, building trust in the student to express their feelings, ensuring part of the attention and acceptance of adults if reporting, proposing hypothetical scenarios, and practicing skills to facilitate teaching students by teachers. And will be parents. In each session, appropriate educational methods for the topics are also provided. After familiarizing teachers and parents with the necessary content and skills, different educational methods, and tailored to the age group of children to teach prevention of sexual abuse, parents and teachers will be taught. These methods are storytelling, drama games, role-playing, video cards, animation, etc. If possible, classes will be held in person, but due to the corona pandemic conditions, training will be provided virtually if not allowed. Virtual education is done online in the environment that was used during the school pandemic, and in case of not using a special environment, Skyroom or Skype is used. At the end of the fourth session, teachers and parents will be retested. Both groups are then asked to share educational content with the children. Education for children is also in a standard and uniform format, which will be in 4 sessions of 20 minutes at a distance of one week, and during this period, both parents and teachers will be followed up weekly to teach them according to the protocol and teaching methods. Cooked to be done. 2 months after the end of the training session for parents and teachers, children will be tested. How to do pre-tests and post-tests will be in person unless the conditions do not allow this access, in which case it will be an online questionnaire for parents and teachers, which can be sent via email or WhatsApp, or other communication tools in cyberspace. At the discretion of the participants. Intervention 2: Intervention group 2: Students who will receive the same training from their parents will be in the second intervention 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 .</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Samaee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Towhid Street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6105 4000</telephone>
        <email>z.samaei75@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Farnaz Farnam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Towhid Street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6105 4217</telephone>
        <email>f_farnam@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria for students:
1)  Age 9-10 years
2) Third grade elementary
3)  Student's consent
4) Parents or guardian's consent
5) Mental health and normal intelligence
Teachers and parents Inclusion criteria  :
1)Teachers and parent's consent
2) Not attending training classes about child sexual abuse prevention in 6 month ago
3) Physical and  mental ability for attendance in class</inclusion_criteria>
      <agemin>9 years</agemin>
      <agemax>10 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>T76.22XA</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>2021 ICD-10-CM Diagnosis Code T76. 22XA: Child sexual abuse, suspected, initial encounter</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: Students who will receive training from their teachers will be in the first intervention group.   To unify the education, the researcher will provide the necessary training about child sexual abuse to teachers and parents simultaneously, in the form of 4  weekly training sessions of 50 minutes. In the first session, the content includes the definition, types, prevalence, complications, risk factors, possible physical, psychological and social symptoms of the child victim, evidence on the impact of education on prevention, barriers for parents and teachers to talk to children, potential benefits and harms. It will be about CSA. In the second session, the concepts of body ownership, private parts of the body, the concept of privacy, defining the trust circle, and how to report suspicious cases will be taught. The content of the third session will include recognizing good and bad touches, distinguishing between right and wrong, the four skills of saying no, leaving the place, the need to report, specifying the list of trusted people to report, and how to report. The content of the fourth session includes ensuring part of the child's innocence, building trust in the student to express their feelings, ensuring part of the attention and acceptance of adults if reporting, proposing hypothetical scenarios, and practicing skills to facilitate teaching students by teachers. And will be parents. In each session, appropriate educational methods for the topics are also provided. After familiarizing teachers and parents with the necessary content and skills, different educational methods, and tailored to the age group of children to teach prevention of sexual abuse, parents and teachers will be taught. These methods are storytelling, drama games, role-playing, video cards, animation, etc. If possible, classes will be held in person, but due to the corona pandemic conditions, training will be provided virtually if not allowed. Virtual education is done online in the environment that was used during the school pandemic, and in case of not using a special environment, Skyroom or Skype is used. At the end of the fourth session, teachers and parents will be retested. Both groups are then asked to share educational content with the children. Education for children is also in a standard and uniform format, which will be in 4 sessions of 20 minutes at a distance of one week, and during this period, both parents and teachers will be followed up weekly to teach them according to the protocol and teaching methods. Cooked to be done. 2 months after the end of the training session for parents and teachers, children will be tested. How to do pre-tests and post-tests will be in person unless the conditions do not allow this access, in which case it will be an online questionnaire for parents and teachers, which can be sent via email or WhatsApp, or other communication tools in cyberspace. At the discretion of the participants.</i_keyword>
      <i_keyword>Intervention group 2: Students who will receive the same training from their parents will be in the second intervention group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Child Sexual abuse Awareness:  Children's knowledge about definitions and prevention of child sexual abuse prevention. Timepoint: At the beginning of the study (before the intervention) and two months after the intervention. Method of measurement: Child Sexual abuse Awareness:: Assessment will be with the "Questionnaire Personal Safety". This questionnaire includes 12 questions to assess children's awareness of sexual abuse. Each question has three options "Yes", "No", "I do not know". Each correct answer will be given a score and the wrong answer and I do not know will not be given a score. Scores range from 0-12 and the highest scores indicate the highest level of students' awareness.</prim_outcome>
      <prim_outcome>Child Sexual abuse skills (self-protective skills): It refers to children's practical skills in protecting themselves from sexual abuse. Timepoint: At the beginning of the study (before the intervention) and two months after the intervention. Method of measurement: Child Sexual abuse skills (self-protective skills): It will be evaluated by What If Situation Test questionnaire.</prim_outcome>
      <prim_outcome>Sexual abuse self-disclosure: Self-disclosure refers to cases of sexual abuse that occurred to the child. Timepoint: At the beginning of the study (before the intervention) and two months after the intervention. Method of measurement: This outcome is measured by three standard questions and students answer these questions to the researcher in the pre-test and post-test.</prim_outcome>
      <prim_outcome>Child's Fear: The meaning of fear in this study is the general fear of students about objects, people and situations under the influence of self-protection educational programs. Timepoint: At the beginning of the study (before the intervention) and two months after the intervention. Method of measurement: Child's Fear: The Fear Assessment Thermometer scale questionnaire measures the level of fear or potential harm of education that measures the level of fear created in the child after these trainings. This questionnaire includes 12 related and unrelated items such as fear of insects, strangers, going to bed, being alone in the dark, going to the doctor, etc.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Teachers and parent's sexual awareness  : refers to the awareness of teachers and parents regarding the prevention of sexual abuse of children. Timepoint: Before and after training teachers and parents. Method of measurement: The CSA Myth Scale questionnaire will be used to assess teachers 'and parents' sexual awareness of child sexual abuse. This questionnaire contains 15 5-item items, from "Strongly Agree" to "Strongly Disagree".</sec_outcome>
      <sec_outcome>Teachers and parent's sexual attitudes : refers to the attitudes of teachers and parents regarding the prevention of child sexual abuse. Timepoint: Before and after training teachers and parents. Method of measurement: The CSA Myth Scale questionnaire will be used to assess teachers 'and parents' sexual attitudes toward child sexual abuse. This questionnaire contains 15 5-item items, from "Strongly Agree" to "Strongly Disagree".</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-04-26</approval_date>
        <contact_name>School of Nursing and Midwifery &amp; Rehabilitation - Tehran University of Medical Science</contact_name>
        <contact_address>Tohid square, Dr.Mirkhani street, school of Nursing and Midwifery Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
