<?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>IRCT20201126049493N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-02-13</date_registration>
      <primary_sponsor>Qazvin University of Medical Sciences</primary_sponsor>
      <public_title>Evaluating The Effect of Mindfulness Group Training on Anxiety, Stress and Depression of mothers with children with learning disabilities</public_title>
      <acronym></acronym>
      <scientific_title>Evaluating The Effect of Mindfulness Group Training on Anxiety, Stress and Depression of mothers with children with learning disabilities</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>44</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/54144</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: A sequence of random numbers will be created using the agricolae package in R software.Samples are randomly divided into control and intervention groups using random blocking method. The size of each block will be equal to two, four or eight samples. People will receive one of the treatments by accident after being assigned to the blocks.</study_design>
      <phase>3</phase>
      <hc_freetext>Learning disability.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The content of the sessions will be held in 8 sessions of 90 minutes twice a week based on the Kabat Zain mindfulness training package in the rehabilitation training center for special learning problems equipped with audio-visual facilities and with a suitable space. Sessions will be held in the form of lectures, questions and answers, group discussions and performing and practicing techniques, as well as using visual aids such as PowerPoint and pictures and in compliance with all health protocols. At the beginning of each session, about 30 minutes are devoted to reviewing the summary of the previous session and doing homework and homework, and then will be accompanied by expressing new content and mindfulness techniques related to the same session, and at the end of the session by delivering attachments Related to the topic of the same session and homework The session ends. DASS-21 questionnaire was completed in three stages in the experimental group, before the intervention, immediately after the sessions and 2 months after training (follow-up) and for the control group in three stages (before, two and four months after). Will be. The treatment protocol used in this study was taken from the practical handbook of cognitive therapy based on the presence of the mind. Intervention 2: Control group: The control group benefits from the routine training and interventions of the center as in the past (they will not have any targeted training and intervention according to the research criteria). The instructor of the sessions is a master student of psychiatric nursing who has passed mindfulness courses. The DASS-21 questionnaire is in the experimental group in three stages, before the intervention, immediately after the sessions and 2 months after Training (follow-up) and for the control group will be completed in three stages (before, two and four months later).</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 Due to the fact that the disclosure of some information is far from ethical, no decision has been made yet.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Elham Hasannia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Qazvin - Shahid Bahonar Boulevard - Qazvin University of Medical Sciences</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3419915315</zip>
        <telephone>+98 28 3333 6001</telephone>
        <email>Elhamhasannia@yahoo.com</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Elham Hasannia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Qazvin - Shahid Bahonar Boulevard - Qazvin University of Medical Sciences</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3419915315</zip>
        <telephone>+98 28 3333 6001</telephone>
        <email>Elhamhasannia@yahoo.com</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Complete satisfaction from participating in the research
Able to speak and understand Persian language
Ability to participate in group intervention sessions
Availability of mothers of children
Having a diploma
Have at least one child with each type of learning disability
Living with a child with a learning disability in a home</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>The presence of parents of children with learning disabilities in a psychotherapy or other counseling process, at the same time as conducting research
Existence of psychiatric disorder (parents' own report on having a history of psychiatric illness and hospitalization due to this)
Taking psychotropic drugs
The child has other medical and psychiatric disorders (based on the student's educational record and parents' self-declaration)
Absence of more than two sessions of training sessions</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F81.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Developmental disorder of scholastic skills, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The content of the sessions will be held in 8 sessions of 90 minutes twice a week based on the Kabat Zain mindfulness training package in the rehabilitation training center for special learning problems equipped with audio-visual facilities and with a suitable space. Sessions will be held in the form of lectures, questions and answers, group discussions and performing and practicing techniques, as well as using visual aids such as PowerPoint and pictures and in compliance with all health protocols. At the beginning of each session, about 30 minutes are devoted to reviewing the summary of the previous session and doing homework and homework, and then will be accompanied by expressing new content and mindfulness techniques related to the same session, and at the end of the session by delivering attachments Related to the topic of the same session and homework The session ends. DASS-21 questionnaire was completed in three stages in the experimental group, before the intervention, immediately after the sessions and 2 months after training (follow-up) and for the control group in three stages (before, two and four months after). Will be. The treatment protocol used in this study was taken from the practical handbook of cognitive therapy based on the presence of the mind.</i_keyword>
      <i_keyword>Control group: The control group benefits from the routine training and interventions of the center as in the past (they will not have any targeted training and intervention according to the research criteria). The instructor of the sessions is a master student of psychiatric nursing who has passed mindfulness courses. The DASS-21 questionnaire is in the experimental group in three stages, before the intervention, immediately after the sessions and 2 months after Training (follow-up) and for the control group will be completed in three stages (before, two and four months later).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Stress. Timepoint: Stress, anxiety and depression variables in the intervention and test groups in three stages, before the intervention, immediately after the sessions and 2 months after the training. Method of measurement: DASS-21 questionnaire.</prim_outcome>
      <prim_outcome>Anxiety. Timepoint: Stress, anxiety and depression variables in the intervention and test groups in three stages, before the intervention, immediately after the sessions and 2 months after the training. Method of measurement: DASS-21 questionnaire.</prim_outcome>
      <prim_outcome>Depression. Timepoint: Stress, anxiety and depression variables in the intervention and test groups in three stages, before the intervention, immediately after the sessions and 2 months after the training. Method of measurement: DASS-21 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>Qazvin University of Medical sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-02-11</approval_date>
        <contact_name>Ethics Committee of Qazvin University of Medical Sciences</contact_name>
        <contact_address>Qazvin University of Medical Sciences, Bahonar Blvd. Qazvin Qazvin Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
