<?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>IRCT2017061034444N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-06-25</date_registration>
      <primary_sponsor>University of Social Welfare and Rehabilitation Sciences</primary_sponsor>
      <public_title>Effects of tuning into kids program on mothers and Preschoolers with behavior problems</public_title>
      <acronym></acronym>
      <scientific_title>The Efficacy of Tuning in to Kids Targeting parents' Emotion style, emotion competence and externalizing behaviors of Preschoolers with behavior problems</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-07-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/26315</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Disruptive behavioral disorders.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: tuning in to kids program  &#13;
(In 8 sessions, developmental information about preschoolers, problem solving and empathy skills along with emotion regulation in response to children's emotion and mothers' emotion via homework, role plays, books and DVD displays are taught.&#13;
session are conducted in 4 preschools located in townships of Haft Hoz, Marzdaran, Gish and Shahrara, in Tehran.). Intervention 2: Control: waiting list for 8- session tuning in to kids program after data collection ended.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fateme Aghaie</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>clinical psychology department, kodakyar Ave., daneshjo Blvd.,Evin</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985713834</zip>
        <telephone>+98 21 6694 1415</telephone>
        <email>fateme.aghaie@yahoo.com; fa.aghaie@uswr.ac.ir</email>
        <affiliation>University of Social Welfare and Rehabilitation Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Parvaneh Mohammadkhani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>department of clinical psychology, university of social welfare and rehabilitation Sciences, kodakyar Ave., daneshjo Blvd.,Evin,</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985713834</zip>
        <telephone>+98 21 2218 0045</telephone>
        <email>parmohamir@yahoo.com</email>
        <affiliation>University of Social Welfare and Rehabilitation Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: receiving diagnosis of disruptive behavior by screening questionnaire CBCL and T score ≥ 65; child age is 3 to 6 years old.&#13;
Exclusion criteria: diagnosis of Autism spectrum disorders or mental retardation.</inclusion_criteria>
      <agemin>3 years</agemin>
      <agemax>6 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F98.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Unspecified behavioural and emotional disorders with onset usually occurring in childhood and adolescence</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>Intervention group: tuning in to kids program  &#13;
(In 8 sessions, developmental information about preschoolers, problem solving and empathy skills along with emotion regulation in response to children's emotion and mothers' emotion via homework, role plays, books and DVD displays are taught.&#13;
session are conducted in 4 preschools located in townships of Haft Hoz, Marzdaran, Gish and Shahrara, in Tehran.)</i_keyword>
      <i_keyword>Control: waiting list for 8- session tuning in to kids program after data collection ended.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Disruptive behavior problems. Timepoint: pre-intervention, post- intervention, 3 month fallow-up. Method of measurement: Eybeg's child behavior inventory (ECBI).</prim_outcome>
      <prim_outcome>Children emotion regulation. Timepoint: pre-intervention, post- intervention, 3 month fallow-up. Method of measurement: emotion regulation checklist ERC.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Maternal emotion style. Timepoint: pre-intervention,post-intervention, 3-month follow-up. Method of measurement: Parent Emotional Style Questionnaire (PESQ).</sec_outcome>
      <sec_outcome>Difficulties in emotion regulation. Timepoint: pre-intervention,post-intervention, 3-month follow-up. Method of measurement: Difficulties in Emotion Egulation Scale (DERS).</sec_outcome>
      <sec_outcome>Matrnal self- efficacy. Timepoint: pre-intervention,post-intervention, 3-month follow-up. Method of measurement: Parenting Self-Agency Measure (PSAM).</sec_outcome>
      <sec_outcome>Mental health. Timepoint: pre-intervention,post-intervention, 3-month follow-up. Method of measurement: General Health Questionnaire (GHQ-28).</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>University of Social Welfare and Rehabilitation Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-09-02</approval_date>
        <contact_name>University of Social Welfare and Rehabilitation Sciences</contact_name>
        <contact_address>kodakyar Ave., daneshjo Blvd.,Evin,Post code: : 1985713834 Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
