<?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>IRCT20190622043972N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-11-13</date_registration>
      <primary_sponsor>Ferdowsi University of Mashhad</primary_sponsor>
      <public_title>The Effect of Mindfulness-Based Therapies in Attention Deficit / Hyperactivity Disorder</public_title>
      <acronym></acronym>
      <scientific_title>Comparison  the Effectiveness  of Child  Mindfulness  Therapy, Mindful Parenting and Combination Therapy of These Two Interventions in Attention Deficit / Hyperactivity Disorder: A Outcome-Based Study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-12-31</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/40587</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, Randomization description: Mashhad Education Department includes 10 districts.The name of each district is recorded on a piece of paper.The pieces of paper are then thrown in a bag.The researcher will put his/her hand in the bag and take out a piece of paper to randomly select the education district.Once the education district has been identified, a list of the district's primary schools will be obtained from the Department of Education, and 10 schools will be selected through a process similar to how the district is selected.Using the SNAP questionnaire, the screening will be done to identify students with suspected ADHD.After screening and conducting a clinical interview, the names of students receiving a definitive diagnosis of ADHD will be written separately on a piece of paper.The names are then poured into a bag.Each time the researcher puts his or her hand in the bag and pulls out a piece of paper.The first 20 people who get out of the bag in this way will be placed in group one, the next 20 people in group two, and the third 20 people in group three.In the next step, the names of the groups will be written separately on three pieces of paper and thrown into the bag.The first piece of paper to come out of the bag after the researcher's hand is inserted into the bag will be group one, the second piece of paper will be group two, and the third piece of paper will be group three.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Attention deficit hyperactivity disorder.</hc_freetext>
      <i_freetext>Intervention 1: The intervention group No. 1 includes children with attention-deficit/ hyperactivity disorder (ADHD) who are subjected to the mindfulness therapy for eight sessions during one month. Treatment sessions are held twice each week. The duration of each session lasts for 45 minutes.The intervention is achieved from the combination of mindfulness-based cognitive therapy and mindfulness-based stress reduction and includes training of increased concentration on the present moment and accepting of experiences through knowledge of the environment, objects, body, and body movements. Intervention 2: The intervention group No. 2 includes parents of children with attention-deficit/ hyperactivity disorder (ADHD) who are subjected to the treatment for one month. The sessions are held weekly and two sessions per week for 45 minutes. This intervention is obtained from two therapeutic protocols of mindfulness-based cognitive therapy and mindfulness-based stress reduction. The contents of the treatment sessions including listening with full attention, acceptance without judgment of oneself and the child, emotional awareness of oneself and the child, self-regulation in parenting relationships, and compassion for oneself and the child. Intervention 3: The intervention No. 3 includes children with attention-deficit/ hyperactivity disorder (ADHD) and their parents. This intervention is a combination intervention that includes mindfulness for afflicted children and mindfulness parenting for parents of these children. Overall, the number of sessions is 16 sessions that eight sessions will be held for children and eight sessions for their parents. The sessions of children and parents will be held in a day, twice a week. The content of the children's and parents' sessions will be similar to the content of the sessions in interventions Nos. 1 and 2.</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 more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zeynab Abdolahzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Educational Sciences and Psychology, Ferdowsi University of Mashhad, Azadi Square.</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9177948974</zip>
        <telephone>0513880500</telephone>
        <email>abdolahzadeh@um.ac.ir</email>
        <affiliation>Ferdowsi University of Mashhad</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ali Mashhadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Educational Sciences and Psychology, Ferdowsi University of Mashhad, Azadi Square</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9177948974</zip>
        <telephone>+98 51 3880 5873</telephone>
        <email>mashhadi@um.ac.ir</email>
        <affiliation>Ferdowsi University of Mashhad</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Receiving a diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD)
Being between the age range of 6 to 12 years
The presence of the children and parents in at least six sessions of treatment</inclusion_criteria>
      <agemin>6 years</agemin>
      <agemax>12 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Children afflicted with other mental disorders
Having an IQ below 80
Receiving simultaneous psychological treatment
Patients without caretakers/attendants or with irresponsible parents/surrogates
Illiteracy of parents
Parents afflicted with mental disorders</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F90</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Attention-deficit hyperactivity disorders</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The intervention group No. 1 includes children with attention-deficit/ hyperactivity disorder (ADHD) who are subjected to the mindfulness therapy for eight sessions during one month. Treatment sessions are held twice each week. The duration of each session lasts for 45 minutes.The intervention is achieved from the combination of mindfulness-based cognitive therapy and mindfulness-based stress reduction and includes training of increased concentration on the present moment and accepting of experiences through knowledge of the environment, objects, body, and body movements.</i_keyword>
      <i_keyword>The intervention group No. 2 includes parents of children with attention-deficit/ hyperactivity disorder (ADHD) who are subjected to the treatment for one month. The sessions are held weekly and two sessions per week for 45 minutes. This intervention is obtained from two therapeutic protocols of mindfulness-based cognitive therapy and mindfulness-based stress reduction. The contents of the treatment sessions including listening with full attention, acceptance without judgment of oneself and the child, emotional awareness of oneself and the child, self-regulation in parenting relationships, and compassion for oneself and the child.</i_keyword>
      <i_keyword>The intervention No. 3 includes children with attention-deficit/ hyperactivity disorder (ADHD) and their parents. This intervention is a combination intervention that includes mindfulness for afflicted children and mindfulness parenting for parents of these children. Overall, the number of sessions is 16 sessions that eight sessions will be held for children and eight sessions for their parents. The sessions of children and parents will be held in a day, twice a week. The content of the children's and parents' sessions will be similar to the content of the sessions in interventions Nos. 1 and 2.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The Main Symptoms of Attention Deficit Hyperactivity Disorder. Timepoint: Before the intervention, after the intervention, three months after the intervention. Method of measurement: Swanson, Nolan and Pelham Rating scale.</prim_outcome>
      <prim_outcome>Executive Function. Timepoint: Before the intervention, after the intervention, three months after the intervention. Method of measurement: Barkley Deficits in Executive Functioning.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Behavior Problems. Timepoint: Before the intervention, after the intervention, three months after the  intervention. Method of measurement: Achenbach Child Behavior Checklist.</sec_outcome>
      <sec_outcome>Sleep Quality. Timepoint: Before the intervention, after the intervention, three months after the  intervention. Method of measurement: Child's Sleep Habits Questionnaire.</sec_outcome>
      <sec_outcome>Parenting Stress. Timepoint: Before the intervention, after the intervention, three months after the  intervention. Method of measurement: Parenting Stress Index.</sec_outcome>
      <sec_outcome>Interactive style of child parent. Timepoint: Before the intervention, after the intervention, three months after the  intervention. Method of measurement: Parent child relationship scale.</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>Ferdowsi University of Mashhad</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-07-03</approval_date>
        <contact_name>Ethics committee of Ferdowsi University of Mashhad</contact_name>
        <contact_address>Bioethics Committee, Room 414, Third Floor, Central Organization,Ferdowsi University of Mashhad, Azadi Square Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
