<?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>IRCT20190307042958N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-10-20</date_registration>
      <primary_sponsor>Gorgan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of personal safety education to mothers on the knowledge and skills about sexual abuse prevention</public_title>
      <acronym></acronym>
      <scientific_title>The effect of personal safety education to mothers on the knowledge and skills on sexual abuse prevention of preschool girls</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-06-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>56</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/38267</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Eligible samples were chosen through systematic random sampling from two health centers, which served the largest and most diverse population in terms of cultural, economic, and social levels. The demographic databases were provided by the health system, and households with a preschool girl were identified (N = 336). To achieve the required sample size of 56, eligible mothers were chosen through systematic random sampling from the list using sampling distance (k), [k=N/n = 336/56 = 6]. From 1 to 6, the number 2 was chosen randomly as the first sample. The second sample was selected by adding the number 6 to the first mother and this process continued until the end. First, the samples were identified. By using a randomized test, the intervention group was selected between the intervention and control groups. Then, the first name was randomly selected of the names of the mothers. The first name was placed in the intervention group, and then the next names sequentially were placed in the control and intervention groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Preventing  child Sexual Abuse.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group (Education by mother): After receiving informed and written consent from the parents. At the beginning of each interview, the concept of "private parts" of the body was taught to the children. After completing interviews with PSQ-P and WIST-P (Time 1), the mothers of the education group were invited to attend mothers' training classes offered the following two days. The personal safety training session was held by the researcher for the mothers of the education group (in 4 groups of 4-8 people for 90-120 minutes), which focused on the importance of preventing CSA and the training needed to protect children's personal safety as well as how to educate their children at home using the Persian version of Body Safety Training workbook (BST; Wurtele, 2007). At the end of the class, each mother was given a copy of the Body Safety Training workbook to teach her daughter over the week. We asked the mothers in the educational group to teach their children at least one lesson a day. During one week of at-home training, the researcher contacted the mothers twice (days 2 and 5) to track the progress of educating their children and answer their questions, if any. Two days after the completion of the one week training by mothers to children, children were interviewed using the PSQ-P and WIST-P (Time 2). Follow-up testing (Time 3) was conducted for children one month after the post-test. Intervention 2: Control group: After receiving informed and written consent from the parents or legal guardians of the children. At the beginning of each interview, the concept of "private parts" of the body was taught to the children. After completing interviews with PSQ-P and WIST-P (time1). Mothers of the control group were thanked for their presence and cooperation, and were asked to revisit 11 days later for the post-test of the children.children in control groups were interviewed using the PSQ-P and WIST-P (Time 2). Follow-up testing (Time 3) was conducted for children in control group one month after the post-test. interested mothers of the control group were given a copy of the BST workbook.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
By anonymizing the participants in this study , all the research results can be shared.

When:
2019

To whom:
Public

Conditions:
Researcher

Where to obtain:
Golestan University of Medical Sciences

How to obtain:
Send an e-mail request to the Dr.Elham Khoury , somayeh gholam farkhani

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Somayeh Gholam Farkhani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Obstetrics and Gynecology, Shohada Hospital</address>
        <city>Quchan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>49341-74515</zip>
        <telephone>+98 51 4725 8085</telephone>
        <email>somayeh.farkhani@gmail.com</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Elham Khoori</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>The top of the sixty hat road</address>
        <city>gorgan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>74515-49341</zip>
        <telephone>+98 17 3245 7085</telephone>
        <email>elikami20@yahoo.com</email>
        <affiliation>Gorgan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Preschool girls</inclusion_criteria>
      <agemin>5 years</agemin>
      <agemax>6 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>T76.22XS</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Child sexual abuse, suspected, sequela</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group (Education by mother): After receiving informed and written consent from the parents. At the beginning of each interview, the concept of "private parts" of the body was taught to the children. After completing interviews with PSQ-P and WIST-P (Time 1), the mothers of the education group were invited to attend mothers' training classes offered the following two days. The personal safety training session was held by the researcher for the mothers of the education group (in 4 groups of 4-8 people for 90-120 minutes), which focused on the importance of preventing CSA and the training needed to protect children's personal safety as well as how to educate their children at home using the Persian version of Body Safety Training workbook (BST; Wurtele, 2007). At the end of the class, each mother was given a copy of the Body Safety Training workbook to teach her daughter over the week. We asked the mothers in the educational group to teach their children at least one lesson a day. During one week of at-home training, the researcher contacted the mothers twice (days 2 and 5) to track the progress of educating their children and answer their questions, if any. Two days after the completion of the one week training by mothers to children, children were interviewed using the PSQ-P and WIST-P (Time 2). Follow-up testing (Time 3) was conducted for children one month after the post-test.</i_keyword>
      <i_keyword>Control group: After receiving informed and written consent from the parents or legal guardians of the children. At the beginning of each interview, the concept of "private parts" of the body was taught to the children. After completing interviews with PSQ-P and WIST-P (time1). Mothers of the control group were thanked for their presence and cooperation, and were asked to revisit 11 days later for the post-test of the children.children in control groups were interviewed using the PSQ-P and WIST-P (Time 2). Follow-up testing (Time 3) was conducted for children in control group one month after the post-test. interested mothers of the control group were given a copy of the BST workbook.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Knowledge. Timepoint: Pretest, post test (one week), follow-up test (one month). Method of measurement: questionnaire.</prim_outcome>
      <prim_outcome>Skill. Timepoint: Pretest, post test (one week), follow-up test (one month). Method of measurement: 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>Gorgan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-05-03</approval_date>
        <contact_name>Ethics committee of Golestan University of Medical Sciences</contact_name>
        <contact_address>Fourth kilometer of Gorgan road Gorgan Golestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
