<?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>IRCT20230929059553N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-05-11</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Comparing the effectiveness of positive parenting intervention program and cognitive therapy based on mindfulness on the quality of parent-child relationships, dysfunctional schema and psychological fatigue in mothers of children with attention deficit/hyperactivity disorder in Kerman city.</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effectiveness of positive parenting intervention program and cognitive therapy based on mindfulness on the quality of parent-child relationships, dysfunctional schema and psychological fatigue in mothers of children with attention deficit/hyperactivity disorder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-05-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/76462</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: The research sample includes 60 mothers of children with attention-deficit/hyperactivity disorder in the 6 months of winter 1401 and has the criteria to enter the intervention, selected in the form of purposeful sampling and simple random allocation in such a way that by assigning a number to each participant and help Writing formulas in Excel, we divide the given numbers into three equal groups of 20 people randomly.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Quality of parent-child relationships. Condition 2: Invalid schema. Condition 3: Psychological fatigue. Condition 4: Attention Deficit/Hyperactivity Disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Positive parenting intervention program that is held in 12 sessions of 75 minutes, each session includes its own program and content, which in summary includes welcoming the participants, explaining the rules of the group, introducing the program and the structure of the session. assessment of parenting styles. Familiarity with positive methods, the necessity of positive interaction, expressing the logic of positive interaction with the child, the basic components of pure positive interaction, specific and meaningful time with the child, talking with the child, physical affection and showing emotions. Teaching modeling techniques, using incidental training (providing more examples of technique practice in small groups, discussion and feedback; using the modeling method. Applying techniques, increasing the desired behavior by using the behavior chart; Teaching the "Ask, Say and Do" method of working on outcomes; Types of orders, principles and how to give orders, considering the logical consequences, expressing the logic of the technique, the difference between the logical consequence and punishment, the principles of implementing the logical consequence of inattention, using the silence time method, expressing the logic of the technique, the steps of implementing the technique, using the method of temporary deprivation, expressing the logic of the technique, the difference between the method of temporary deprivation With the silent time method, steps and how to use the summarizing technique. Use of behavioral methods. Post-test and general summary. Intervention 2: Intervention group 2: cognitive therapy based on mindfulness, package therapy based on Crane (2009); Reams and Wingrow (2013); Saravi (1995), Neff (2010) will be presented. The first and second session: introduction, explanation about the principles of the group, explanation of automatic guidance, meditation and body inspection, distribution of the meditation CD and related pamphlets. The third and fourth session: performing body inspection meditation. Ten minutes of breathing with mindfulness and mind meditation, practicing eating raisins with mindfulness, discovering pleasant experiences using the form for recording pleasant events, and reviewing the tasks of the session before the fifth session: breathing with mindfulness, keeping thoughts and mind wide by following. Caregivers' exercises and focus on conscious breathing and body parts, three minutes of breathing, discovery of daily unpleasant experiences using the unpleasant events registration form, review of the tasks of the previous session Sixth session: 5 minutes of seeing and hearing with mindfulness, 3 minutes of breathing, performing body inspection exercises, explaining the relationship between mind and body, discovering and defining the problem of chronic fatigue syndrome (explaining the symptoms of fatigue with the help of people and completing it), using the system Solving the problem to eliminate fatigue, helping people in preparing a list of activities that give them a sense of usefulness and pleasure and doing them when thoughts or feelings related to fatigue come to them. Helping people in planning. Regular activities and their gradual increase. Seventh and eighth session: practice of permission to attend when thoughts related to fatigue come to them. An overview of the problems associated with fatigue and their complications and the problem solving technique, etc., the presentation of the Roman parable (Moulana) and other parables and the discovery of the content appropriate to their goals in the group. Ninth session: Teaching that thoughts do not have a real origin, awareness of the body's breathing - raising people's problems during exercise and discovering its effects on the body and mind, three minutes of breathing, an overview of problem solving techniques in dealing with thoughts and states of fatigue, attention technique training Returning in times of fatigue, helping them to identify perfectionistic thoughts associated with fatigue, members talking about the experiences gained during the sessions of the 10th and 11th sessions: how to take care of ourselves in the best way, awareness of breathing, body parts, sounds , thoughts and emotions, carrying out physical examination exercises, reviewing topics related to fatigue, getting feedback from people, examining ways to increase useful activity, 12th session: body examination meditation, summarizing the use of this program, end of treatment. Intervention 3: Control group: Control group: People in this group do not receive any intervention.</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:
The raw data file extracted inside the questionnaires, the analysis fileStatistical data

When:
The access period starts 8 months after the results are published

To whom:
Only for researchers and employees in academic institutions

Conditions:
In order to use this data during communication, necessary arrangements are made regarding the permitted analysis method. They can only be used for academic research

Where to obtain:
They can make necessary arrangements to receive data by sending emails and communicating. . masoome.karimi.1401@gmail.com

How to obtain:
After the request is made by the applicant and confirmation is received from the supervisor, the data file is sent via email

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Masoome Karimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>1 Alley- Jannet St.- Zarand</address>
        <city>Zarand</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7617717151</zip>
        <telephone>+98 35 3343 7273</telephone>
        <email>masoome.karimi.1401@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Masoome Karimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>1 Alley- Jannet St.- Zarand</address>
        <city>Zarand</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7617717151</zip>
        <telephone>+98 35 3343 7273</telephone>
        <email>masoome.karimi.1401@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>A low score in the parent-child relationship quality questionnaire
High score in dysfunctional schema questionnaire
High score in psychological fatigue questionnaire
High score in children's behavioral disorders questionnaire (hyperactivity/attention deficit)
Absence of psychotic and paranoid disorders in mothers</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>The presence of one or more mental disorders or physical diseases in the child
Mother's illiteracy
Being a single parent of a child</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
      <hc_code>F90.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword>Attention-deficit hyperactivity disorder, predominantly inattentive type</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: Positive parenting intervention program that is held in 12 sessions of 75 minutes, each session includes its own program and content, which in summary includes welcoming the participants, explaining the rules of the group, introducing the program and the structure of the session. assessment of parenting styles. Familiarity with positive methods, the necessity of positive interaction, expressing the logic of positive interaction with the child, the basic components of pure positive interaction, specific and meaningful time with the child, talking with the child, physical affection and showing emotions. Teaching modeling techniques, using incidental training (providing more examples of technique practice in small groups, discussion and feedback; using the modeling method. Applying techniques, increasing the desired behavior by using the behavior chart; Teaching the "Ask, Say and Do" method of working on outcomes; Types of orders, principles and how to give orders, considering the logical consequences, expressing the logic of the technique, the difference between the logical consequence and punishment, the principles of implementing the logical consequence of inattention, using the silence time method, expressing the logic of the technique, the steps of implementing the technique, using the method of temporary deprivation, expressing the logic of the technique, the difference between the method of temporary deprivation With the silent time method, steps and how to use the summarizing technique. Use of behavioral methods. Post-test and general summary</i_keyword>
      <i_keyword>Intervention group 2: cognitive therapy based on mindfulness, package therapy based on Crane (2009); Reams and Wingrow (2013); Saravi (1995), Neff (2010) will be presented. The first and second session: introduction, explanation about the principles of the group, explanation of automatic guidance, meditation and body inspection, distribution of the meditation CD and related pamphlets. The third and fourth session: performing body inspection meditation. Ten minutes of breathing with mindfulness and mind meditation, practicing eating raisins with mindfulness, discovering pleasant experiences using the form for recording pleasant events, and reviewing the tasks of the session before the fifth session: breathing with mindfulness, keeping thoughts and mind wide by following. Caregivers' exercises and focus on conscious breathing and body parts, three minutes of breathing, discovery of daily unpleasant experiences using the unpleasant events registration form, review of the tasks of the previous session Sixth session: 5 minutes of seeing and hearing with mindfulness, 3 minutes of breathing, performing body inspection exercises, explaining the relationship between mind and body, discovering and defining the problem of chronic fatigue syndrome (explaining the symptoms of fatigue with the help of people and completing it), using the system Solving the problem to eliminate fatigue, helping people in preparing a list of activities that give them a sense of usefulness and pleasure and doing them when thoughts or feelings related to fatigue come to them. Helping people in planning. Regular activities and their gradual increase. Seventh and eighth session: practice of permission to attend when thoughts related to fatigue come to them. An overview of the problems associated with fatigue and their complications and the problem solving technique, etc., the presentation of the Roman parable (Moulana) and other parables and the discovery of the content appropriate to their goals in the group. Ninth session: Teaching that thoughts do not have a real origin, awareness of the body's breathing - raising people's problems during exercise and discovering its effects on the body and mind, three minutes of breathing, an overview of problem solving techniques in dealing with thoughts and states of fatigue, attention technique training Returning in times of fatigue, helping them to identify perfectionistic thoughts associated with fatigue, members talking about the experiences gained during the sessions of the 10th and 11th sessions: how to take care of ourselves in the best way, awareness of breathing, body parts, sounds , thoughts and emotions, carrying out physical examination exercises, reviewing topics related to fatigue, getting feedback from people, examining ways to increase useful activity, 12th session: body examination meditation, summarizing the use of this program, end of treatment</i_keyword>
      <i_keyword>Control group: Control group: People in this group do not receive any intervention</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The quality of parent-child relationships is the score given by the person in the Mark Fein, J. Moreland, and Andrew Schoebel (1983). Timepoint: This questionnaire is completed at the beginning of the sampling and at the end of the research after the interventions. Method of measurement: Parent-Child Relationship Assessment Questionnaire (PCRS) by Mark A. Fine, J. R. Moreland, and Andrew Schoebel (1983) was constructed consisting of 24 items.</prim_outcome>
      <prim_outcome>Dysfunctional schema is the score that a person gets in Leahy's emotional schemas test (Khanzadeh, Idrisi, Mohammadkhani and Saidian, 2013). Timepoint: This questionnaire is completed at the beginning of the sampling and at the end of the research after the interventions. Method of measurement: This scale has 75 items that are scored using a 5-point Likert scale that was prepared by Khanzadeh, Idrisi, Mohammadkhani and Saidian (2013).</prim_outcome>
      <prim_outcome>Psychological fatigue is the score that a person obtains in the Multidimensional Fatigue Measurement Questionnaire (MFI) by Smets (1996). Timepoint: This questionnaire is completed at the beginning of the sampling and at the end of the research after the interventions. Method of measurement: The multidimensional fatigue measurement questionnaire (MFI) was created by Smets (1996), which consists of 20 items and 5 subscales of general fatigue (4 questions), physical fatigue (4 questions), decreased activity (4 questions), and decreased motivation (4 questions). and mental fatigue (4 questions).</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-09-09</approval_date>
        <contact_name>Research Ethics Committee of Islamic Azad University - Kerman branch</contact_name>
        <contact_address>Islamic Azad University - Imam Ali Boulevard Kerman Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
