<?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>IRCT20240510061727N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-05-21</date_registration>
      <primary_sponsor>Rasht University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of the Teach-back method on Parents Knowledge and Performance in relation to the Safety Care of Children with Autism</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of the Teach-back method on Parents Knowledge and Performance in relation to the Safety Care of Children with Autism (Randomized Controlled Trials)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>72</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/76721</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization of the samples will be used based on the Random Allocation software, in this study, according to the sample size, using the block randomization method, 9 blocks of 4 will be divided into intervention and control groups.
To generate the randomization list, Random Block software will be selected and the sequence of entering the samples in the educational intervention and non-educational intervention groups will be selected based on the list of cases of children with autism in the centers covered by the Rasht Welfare Department.
For concealment, the sequence list is kept in a sealed envelope with the supervisor (Dr. Yasman Yaghoubi), and after obtaining permission to conduct the research and the necessary coordination, the envelope is opened and read daily in the relevant centers, Blinding description: Given that the researcher knows the characteristics of the control and intervention group participants, there is no possibility of blinding the researcher. On the other hand, the program is explained in the consent form that is given to the participants, and therefore the participants will be assigned to the control and intervention groups, so there will be no possibility of blinding the participants. Only the statistician will not be aware of the assignment of samples to the control and intervention groups, and therefore, blinding will be done only for the statistician.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Autism.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Before the start of the first training session, the questionnaires will be sent privately to the intervention group through the Ita and Baleh messenger, in coordination with the center officials and parents, the training will be carried out on specific days in the respective centers, before the start of the first training session of the group participants. intervention, they will be divided into 4 groups of 9 people, on the first day, the goals of the research project will be explained to the parents again, the main goal of the research will be education about safety care, and if they have any questions outside of the goals, they will be referred to the psychologist of the center. According to the program, during 3 weeks, one day per week and one hour per day, educational sessions will be held, so that in the first session, the prepared educational content will be presented through interactive lectures to the participants who are present in the groups. At the end of the first session, the participants are asked to write down the topics that are unclear to them or need more training on a sheet and provide them to the researcher. In the second session, the educational content according to the course plan, and then based on the needs assessment of each group, vague topics will be prepared separately and presented in an interactive lecture style in different groups, at the end of the second session, a survey of the participants regarding the proposal for improvement The solution will be implemented to help awareness and practice in connection with the safety care of children with autism. In the third session, the educational content will be prepared and presented according to the course plan and then based on the results of the survey in the second session. At the end of all three sessions, the parent's understanding of the given education will be measured by asking them to repeat the content. In case of incomplete or wrong understanding, the educational materials will be repeated and reviewed, and scenarios will be presented for group discussion to ensure parents' understanding. After one month from the last training session, the questionnaires of parents' awareness and performance regarding the safety care of children with autism will be provided to the learners through the messenger Ita and Baleh , to measure the level of awareness and performance of parents of children with autism. Intervention 2: Control group: No training or action will be taken for the control group, before the start of the first training session in the intervention group, the questionnaires will be sent privately to the control group through the Ita and Baleh messenger, and again one month after the last training session in the intervention group, the questionnaires will be sent through It will be sent to the control group. After receiving the questionnaires, following the response of the control group, to use the educational content for the parents of this group, the educational package will be uploaded at the end of the study.</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:
Part of individual data in demographic questionnaire.
Total awareness and performance data.

When:
The access period starts one year after the results are published.

To whom:
All researchers in academic institutions and businesses.

Conditions:
No decision has been made yet.

Where to obtain:
Dr. Yasman Yagoubi, assistant professor of Rasht University of Medical Sciences, email address yaghobiyasaman@yahoo.com
Maryam Moradi, Master student of Rasht University of Medical Sciences, email address mrymrdi99@gmail.com

How to obtain:
It will be sent as soon as possible after the checks done by the researcher.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Moradi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Beheshti Highway - Student Street</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>41469-39814</zip>
        <telephone>+98 13 3355 3202</telephone>
        <email>Mrymrdi99@gmail.com</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Yasaman Yaghobi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Beheshti Highway - Student Street</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>41469-39814</zip>
        <telephone>+98 13 3355 3202</telephone>
        <email>Yaghobiyasaman@yahoo.com</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Parents should be willing to participate in the research.
Parents are responsible for taking care of autistic children.
The file of the child with autism is under the care of the parents in the welfare center of Rasht city.
Parents should take care of a child with autism at home.
Parents should have a smartphone.
Parents should have access to the Internet and virtual networks.
Parents should be able to use mobile phones and virtual networks.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Parents have a psychological illness based on self-report.
The child is suffering from other chronic diseases (physical and psychological).
Parents have participated in educational and support programs similar to the intervention in the last year.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F84.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Autistic disorder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Before the start of the first training session, the questionnaires will be sent privately to the intervention group through the Ita and Baleh messenger, in coordination with the center officials and parents, the training will be carried out on specific days in the respective centers, before the start of the first training session of the group participants. intervention, they will be divided into 4 groups of 9 people, on the first day, the goals of the research project will be explained to the parents again, the main goal of the research will be education about safety care, and if they have any questions outside of the goals, they will be referred to the psychologist of the center. According to the program, during 3 weeks, one day per week and one hour per day, educational sessions will be held, so that in the first session, the prepared educational content will be presented through interactive lectures to the participants who are present in the groups. At the end of the first session, the participants are asked to write down the topics that are unclear to them or need more training on a sheet and provide them to the researcher. In the second session, the educational content according to the course plan, and then based on the needs assessment of each group, vague topics will be prepared separately and presented in an interactive lecture style in different groups, at the end of the second session, a survey of the participants regarding the proposal for improvement The solution will be implemented to help awareness and practice in connection with the safety care of children with autism. In the third session, the educational content will be prepared and presented according to the course plan and then based on the results of the survey in the second session. At the end of all three sessions, the parent's understanding of the given education will be measured by asking them to repeat the content. In case of incomplete or wrong understanding, the educational materials will be repeated and reviewed, and scenarios will be presented for group discussion to ensure parents' understanding. After one month from the last training session, the questionnaires of parents' awareness and performance regarding the safety care of children with autism will be provided to the learners through the messenger Ita and Baleh , to measure the level of awareness and performance of parents of children with autism.</i_keyword>
      <i_keyword>Control group: No training or action will be taken for the control group, before the start of the first training session in the intervention group, the questionnaires will be sent privately to the control group through the Ita and Baleh messenger, and again one month after the last training session in the intervention group, the questionnaires will be sent through It will be sent to the control group. After receiving the questionnaires, following the response of the control group, to use the educational content for the parents of this group, the educational package will be uploaded at the end of the study.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>In this study, the awareness and performance of parents of children with autism are measured about preventive care; For this purpose, awareness is the primary outcome. Timepoint: It will be done 2 times, before the start of the first training session and one month after the last training session. Method of measurement: A researcher-made questionnaire in the field of parents' awareness about the safe care of children with autism, which questionnaires have been reviewed by 11 faculty members of Shahid Beheshti School of Nursing and Midwifery in Rasht, the content validity ratio in these two questionnaires has been acceptable, and the content validity index has been approved for The awareness questionnaire is 0.92. To determine the internal consistency of the awareness questionnaire, Richardson20 was used. The Richardson20 coefficient was obtained as 0.717 after removing question 17, so this tool with 24 questions has acceptable internal consistency. To determine the external consistency of the awareness questionnaire, the ICC coefficient and Test-Retest coefficient were used. became. The Test-Retest coefficient of the two knowledge questionnaires was 91.4% and the ICC coefficient was 0.952; Therefore, the awareness tool has acceptable reliability in terms of external stability.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The secondary outcome is performance. Timepoint: It will be done 2 times, before the start of the first training session and one month after the last training session. Method of measurement: A researcher-made questionnaire in the field of parents' performance in connection with the safe care of children with autism, the questionnaires have been reviewed by 11 faculty members of the Shahid Beheshti College of Nursing and Midwifery in Rasht, the content validity ratio has been acceptable and the content validity index has been approved for the questionnaire. The performance is 0.94. Alpha Cronbach's coefficient was used to check the internal consistency of the performance questionnaire, and the alpha Cronbach's coefficient was 0.901, so this instrument has acceptable internal consistency with 25 questions. Also, the ICC coefficient and Test-Retest coefficient were used to determine the external stability of the performance tool. The test-retest coefficient of two performance questionnaires was 99.2% and the ICC coefficient was 0.981; Therefore, the performance tool has acceptable reliability in terms of external stability.</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>Rasht University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-05-01</approval_date>
        <contact_name>Research Ethics Committee of Guilan University of Medical Sciences</contact_name>
        <contact_address>Namjo St., in front of Azodi Stadium. Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
