<?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>IRCT20221227056942N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-10-08</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Assessment of the effectiveness of psychoeducation for mothers of children aged 8 to 12 years with type 1 diabetes on HbA1c, self-management, quality of life and social support of children.</public_title>
      <acronym></acronym>
      <scientific_title>Assessment of the effectiveness of psychoeducation for mothers of children aged 8 to 12 years with type 1 diabetes on HbA1c, self-management, quality of life and social support of children.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>48</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72932</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The sampling method is random, and in the first stage, the sampling method was consecutive, and then in the random sampling method, double blocks were used for random allocation. Then the members of each block of two were sorted according to the national code and the table of random numbers was used in such a way that for numbers 0 to 4 the first person was moved to group 1 and the second person to group 2 and for numbers 5 to 9 people The second person was transferred to group 1 and the first person was transferred to group 2, and this work continued until the sample size was sufficient, and after that, the table of random numbers was used again to determine groups 1 and 2, in such a way that for numbers 0 to 4 groups of psychological training group 1 and control group group 2 were determined and for numbers 5 to 9 psychological training group group 2 and control group group 1 were selected.</study_design>
      <phase>N/A</phase>
      <hc_freetext>type 1 diabetes mellitus.</hc_freetext>
      <i_freetext>Intervention 1: Control group: A series of educational pamphlets with the content of the importance of blood sugar regulation and the warning signs of hypoglycemia and hyperglycemia have been provided, and during eight face-to-face orientation sessions, the contents of these pamphlets have been taught and reviewed, as well as the daily experiences and challenges of these mothers regarding their children's diabetes in the presence of the therapist. And without providing specific training, a group discussion will take place. Intervention 2: Intervention group: Intervention group: in the experimental group of mothers of diabetic children, in addition to the cases mentioned in the control group, in two psychological training groups of 12 people during 8 weekly one-hour sessions according to the protocol that was used based on foreign articles, in the Siddigeh Endocrine and Metabolism Center Tahereh Isfahan received training. The general content of the training sessions includes: first session: introduction to diabetes and the type of intervention - second session: teamwork and family communication - third session: blood sugar monitoring and medication use - fourth session: problem solving skills - The fifth session: Avoiding perfectionism and setting realistic goals - The sixth session: The importance of weight management - The seventh session: Reducing the feeling of exhaustion and gaining social support - The eighth session: Ways to stay motivated.</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 There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Reza Bagherian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Isfahan University of Medical Sciences, Hazar Jarib Street, Isfahan</address>
        <city>isfehan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>009832371103</telephone>
        <email>bagherian@med.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Amrollah Ebrahim</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Isfahan University of Medical Sciences, Hazar Jarib Street, Isfahan</address>
        <city>isfehan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>009832371103</telephone>
        <email>amrollahebi@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Children with type 1 diabetes aged 8 to 12 years
6 months have passed since the diagnosis of their disease
Absence of concomitant psychiatric disorder in children
having minimum reading and writing literacy in mothers
Willingness to cooperate</inclusion_criteria>
      <agemin>8 years</agemin>
      <agemax>12 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Failure to complete questionnaires correctly
Lack of regular participation in psychological training sessions</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E10</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Type 1 diabetes mellitus</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Placebo</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: A series of educational pamphlets with the content of the importance of blood sugar regulation and the warning signs of hypoglycemia and hyperglycemia have been provided, and during eight face-to-face orientation sessions, the contents of these pamphlets have been taught and reviewed, as well as the daily experiences and challenges of these mothers regarding their children's diabetes in the presence of the therapist. And without providing specific training, a group discussion will take place.</i_keyword>
      <i_keyword>Intervention group: Intervention group: in the experimental group of mothers of diabetic children, in addition to the cases mentioned in the control group, in two psychological training groups of 12 people during 8 weekly one-hour sessions according to the protocol that was used based on foreign articles, in the Siddigeh Endocrine and Metabolism Center Tahereh Isfahan received training. The general content of the training sessions includes: first session: introduction to diabetes and the type of intervention - second session: teamwork and family communication - third session: blood sugar monitoring and medication use - fourth session: problem solving skills - The fifth session: Avoiding perfectionism and setting realistic goals - The sixth session: The importance of weight management - The seventh session: Reducing the feeling of exhaustion and gaining social support - The eighth session: Ways to stay motivated.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Diabetes self-management questionnaire score. Timepoint: Before the intervention, immediately after the intervention and 3 months after the intervention. Method of measurement: Diabetes self-management questionnaire.</prim_outcome>
      <prim_outcome>Questionnaire of the quality of life of children aged 8 to 12 years. Timepoint: Before the intervention, immediately after the intervention and 3 months after the intervention. Method of measurement: Questionnaire of the quality of life of children aged 8 to 12 years score.</prim_outcome>
      <prim_outcome>Child and adolescent social support scale score. Timepoint: Before the intervention, immediately after the intervention and 3 months after the intervention. Method of measurement: Child and adolescent social support scale.</prim_outcome>
      <prim_outcome>Child behavior questionnaire score. Timepoint: Before the intervention, immediately after the intervention and 3 months after the intervention. Method of measurement: Child behavior questionnaire.</prim_outcome>
      <prim_outcome>Hba1c level. Timepoint: Before the intervention, immediately after the intervention and 3 months after the intervention. Method of measurement: blood test.</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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-10-02</approval_date>
        <contact_name>EthicS Committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Isfahan University of Medical Sciences, Hazar Jerib Street, Isfahan Isfehan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
