<?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>IRCT20171231038153N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-02-07</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of occupation-centered interventions on self- determination of adolescents</public_title>
      <acronym></acronym>
      <scientific_title>The effect of occupation-centered interventions on self- determination of female adolescents at risk of Emotional-Behavioral Disorders according to MOHO</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>54</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/28620</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: Three-stage cluster sampling(Education areas, schools, students)
 Restricted randomization methods and Permuted block randomization will be used to select students.  
Randomization tool is  Random number table .
allocation concealment is done as intervention and control groups are not known, Blinding description: Collection of research data are conducted by evaluators who are unaware of the participants in the intervention and control group.
Analysis of the research data is analyzed by statisticians who are unaware of the groups.</study_design>
      <phase>3</phase>
      <hc_freetext>َََAt risk of Emotional-behavioral disorders.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The content of the intervention will be based on the protocol contained in the STEPS To Self-Determination Curriculum, with permission from the authors of the book.Designing a set of occupations based on the interests and culture of adolescents participating in intervention and Confirming at a meeting of experts .Participants in the intervention group are divided into three groups of 5 to 7 people.Assignment of people in each group is done in accordance with the uniformity and participation in the interests of the participants according to the form of MOHO Interests.The intervention will be held for 8 sessions of 90 minutes per week (according to available resources and articles) for the intervention group. Intervention 2: Control group: Includes 20 students at risk for emotional-behavioral disorders that 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>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>Elahe Hojati Abed</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Rehabilitation Sciences of,Iran University of Medical Sciences Madadkaran st, Shahnazari st, Madar Square. Mirdamad BLV</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>15875-4391</zip>
        <telephone>+98 21 2222 8051</telephone>
        <email>hojatiabed.e@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nargess Shafaroodi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Rehabilitation Sciences, Iran University of Medical Siences, Madadkaran streert, Shahnazari Street, Mother Field, Mirdamd Boulevard</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>15875-4391</zip>
        <telephone>+98 21 2222 8051</telephone>
        <email>shafarodi.n@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age of 14 to 16 years
Female gender
Gain cutting scores (above 60) in the test of Youth Self Report
Studying in high school</inclusion_criteria>
      <agemin>14 years</agemin>
      <agemax>16 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Lack of cooperation in intervention
Two consecutive absence occasions Or four absentee sessions in total</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F01-F99</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Behavioral and emotional disorders with onset usually occurring in childhood and adolescence.</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The content of the intervention will be based on the protocol contained in the STEPS To Self-Determination Curriculum, with permission from the authors of the book.Designing a set of occupations based on the interests and culture of adolescents participating in intervention and Confirming at a meeting of experts .Participants in the intervention group are divided into three groups of 5 to 7 people.Assignment of people in each group is done in accordance with the uniformity and participation in the interests of the participants according to the form of MOHO Interests.The intervention will be held for 8 sessions of 90 minutes per week (according to available resources and articles) for the intervention group.</i_keyword>
      <i_keyword>Control group: Includes 20 students at risk for emotional-behavioral disorders that do not receive any intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Student self-determination is a 92-item self-report instrument that measures both affective and cognitive aspects of the student’s self-determination.including General Positive, General Negative, Specific Positive, and Specific Negative. The general subscales relate to a student’s sense of global self-determination, while the specific subscales relate primarily to application in their education, home, and related environmental settings. The positive subscales indicate self-determination in areas of perceived strength, while the negative subscales indicate areas of perceived weakness in self-determination. Timepoint: At the begining of interventio; At the end of intervention (after 8 weeks) and after 10 weeks (follow up). Method of measurement: Self-Determination Student Scale.</prim_outcome>
      <prim_outcome>Self-Determination Parent Perception Scale: Parents' perceptions of their child's self-determination behaviors, abilities and skills. Timepoint: At the Beginning of intervention ; At the end of intervention (after 8 weeks) and after 10 weeks (follow up). Method of measurement: Self-Determination Parent Perception Scale (PPS).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Communication and Interaction Skills: Refers to behaviors that one can communicate with others through these behaviors, which leads to positive responses and negative responses. Timepoint: At the Beginning of intervention; At the end of intervention (after 8 weeks) and after 10 weeks (follow up). Method of measurement: In this research, Communication skills include 20 items that are classified into three areas of physicality , information exchange and relations Which is measured by the communication and interaction skills assessment(ACIS).</sec_outcome>
      <sec_outcome>Executive function:Executive functions are an idiomatic term that covers all of the complex cognitive processes that are required for task-oriented, difficult or new assignment tasks. Timepoint: At the Beginning of intervention; At the end of intervention (after 8 weeks) and after 10 weeks (follow up). Method of measurement: In this research, execution function is measured by three  software programs, TOWER OF LONDON TEST; Go No Go; BART TASK.The decision making, problem solving, and risk-taking are evaluated.</sec_outcome>
      <sec_outcome>Academic Achievement: The ability to prove success in acquiring an outcome for which learning experiences are projected. Timepoint: First semester;The end of the academic year. Method of measurement: In this study, academic achievement is the average of the second-order scores of school.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-12-28</approval_date>
        <contact_name>Ethics committee of Iran university medical sciences</contact_name>
        <contact_address>Iran University of Medical Sciences, Hemat Highway next to Milad Tower, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
