<?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>IRCT20231126060188N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-12-19</date_registration>
      <primary_sponsor>Semnan University of Medical Sciences</primary_sponsor>
      <public_title>The effectiveness of parental management training on chronic fatigue syndrome and mother-child conflicts</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness of parental management training on chronic fatigue syndrome and mother-child conflicts in hyperactive children aged 8 to 12 years in Sari city.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-05-24</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/73959</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Diagnostic, Randomization description: From among the statistical population, according to the nature and method of the research, 30 mothers who were willing to participate in the parenting management training sessions were selected according to the access and exit conditions of the study.  Then they were placed randomly in two experimental and control groups (15 people each).  After making the necessary arrangements and obtaining the necessary permits, with the coordination and cooperation of the center's psychologist, the day and time of the treatment for the experimental group were determined.  Then, by observing the ethical considerations and stating the goals of the research and justifying the research sample, by informing the sample members, among the people who met the conditions and criteria of the research, the sample people will be held for eight sessions for 90 minutes, and two sessions will be held every week.  .  And assigned to two intervention groups and control group, and before the intervention, the subjects of both groups completed the multi-dimensional fatigue measurement questionnaire and the maternal quality scale questionnaire.  Then the intervention group was trained in the parent management program and the control group did not receive any intervention.  After completing the training, the questionnaires were filled again by the subjects of both groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>The effectiveness of parental management training on chronic fatigue syndrome and mother-child conflicts.</hc_freetext>
      <i_freetext>Intervention 1: The first intervention group: From among the statistical population, according to the nature and method of the research, 30 mothers who were willing to participate in parenting management training sessions were selected according to the access and exit conditions of the study. Then they are placed randomly in two experimental and control groups (15 people each). After making the necessary arrangements and obtaining the necessary permits, with the coordination and cooperation of the psychologist of the center, the day and time of treatment for the experimental group will be determined. Then, the sample subjects will receive intervention for eight 90-minute sessions (two sessions per week). Both the intervention group and the control group before the start of the intervention, the subjects of both groups completed the multidimensional fatigue measurement questionnaire and the maternal quality scale questionnaire, and then the intervention group will be trained in the parent management program, and the control group will not receive any intervention. After completing the training, the questionnaires will be filled again by the subjects of both groups. A summary of treatment goals and methods: 1st session: changing parents' attitude towards disorder and problematic behavior, assignment of praise and attention technique; The second session: application of rewards and points, the task of completing the positive reinforcement table; The third session: learning the techniques of praise and encouragement, the technique of dedication in strengthening; The fourth session: teaching behavioral management of parents, the task of paying attention and ignoring; The fifth session: improving the child's behavior in school, fines and exclusions; Sixth session: preventing severe misbehavior, reward removal technique; Seventh session: modification of parents' attitude, technique of surrendering what has been learned; Eighth session: review of learned material and how to manage problems in the future, home and school communication assignment. Intervention 2: Control group: The first control group: after selecting the subjects and conducting the necessary investigations to enter the research, it is now time to randomly divide people into two control and intervention groups. The control group will not receive any intervention, but after the intervention, the experimental group will be invited to answer all 2 questionnaires again. The pre-test and post-test scores of the two groups are compared. The number of people in this group will be 15 people.</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 Its release schedule is unknown</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>sogandasghari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Avesta Apartment, Nasohi Alley, Salman Farsi St., Taleqani Blvd., Sari</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3711135131</zip>
        <telephone>+98 11 3320 9593</telephone>
        <email>sogandasghari2@gmail.com</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sogand Asghari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Avesta Apartment, Nasohi Alley, Salman Farsi St., Taleqani Blvd., Sari</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4818917371</zip>
        <telephone>+98 11 3320 9593</telephone>
        <email>sogandasghari2@gmail.com</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Absence of mental disorders in mother and child
The age range of the child is 8 to 12 years.
The ability to participate in therapy sessions</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Children with chronic diseases
Mental retardation, physical disability, use of sleeping pills.
Undergoing other special treatments.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F90.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Attention-deficit hyperactivity disorder, predominantly inattentive type</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The first intervention group: From among the statistical population, according to the nature and method of the research, 30 mothers who were willing to participate in parenting management training sessions were selected according to the access and exit conditions of the study. Then they are placed randomly in two experimental and control groups (15 people each). After making the necessary arrangements and obtaining the necessary permits, with the coordination and cooperation of the psychologist of the center, the day and time of treatment for the experimental group will be determined. Then, the sample subjects will receive intervention for eight 90-minute sessions (two sessions per week). Both the intervention group and the control group before the start of the intervention, the subjects of both groups completed the multidimensional fatigue measurement questionnaire and the maternal quality scale questionnaire, and then the intervention group will be trained in the parent management program, and the control group will not receive any intervention. After completing the training, the questionnaires will be filled again by the subjects of both groups. A summary of treatment goals and methods: 1st session: changing parents' attitude towards disorder and problematic behavior, assignment of praise and attention technique; The second session: application of rewards and points, the task of completing the positive reinforcement table; The third session: learning the techniques of praise and encouragement, the technique of dedication in strengthening; The fourth session: teaching behavioral management of parents, the task of paying attention and ignoring; The fifth session: improving the child's behavior in school, fines and exclusions; Sixth session: preventing severe misbehavior, reward removal technique; Seventh session: modification of parents' attitude, technique of surrendering what has been learned; Eighth session: review of learned material and how to manage problems in the future, home and school communication assignment</i_keyword>
      <i_keyword>Control group: The first control group: after selecting the subjects and conducting the necessary investigations to enter the research, it is now time to randomly divide people into two control and intervention groups. The control group will not receive any intervention, but after the intervention, the experimental group will be invited to answer all 2 questionnaires again. The pre-test and post-test scores of the two groups are compared. The number of people in this group will be 15 people.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>High score in attention deficit hyperactivity disorder questionnaire. Timepoint: Before the beginning of the therapeutic intervention in the first session. Method of measurement: Swanson and Pelham Attention Deficit Hyperactivity Disorder Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Score in multidimensional fatigue measurement questionnaire (MFI). Timepoint: After the completion of therapeutic intervention in the eighth session. Method of measurement: Multidimensional Fatigue Measurement Questionnaire (MFI).</sec_outcome>
      <sec_outcome>Score in maternal quality questionnaire. Timepoint: After the completion of therapeutic intervention in the eighth session. Method of measurement: Pianta Maternal Quality Questionnaire.</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>Semnan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-07-04</approval_date>
        <contact_name>Working group/committee of ethics in research, Islamic Azad University, Semnan branch</contact_name>
        <contact_address>5 km of Semnan road Semnan Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
