<?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>IRCT20181008041274N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-05-04</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The effectiveness of child_centred play therapy on internalization and extrapolation behavioral problems in children with cerebral palsy</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of child-centered play therapy on internalization and extrapolation behavioral problems in children with cerebral palsy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-04-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/35678</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple and individual randomization method was used in this study. In this method, there is the probability of inequality of the subjects assigned to each of the groups, especially in studies with small sample size. Due to the small sample size, instead of using random numbers table, randomization method was assigning the members of the population on a piece of paper and placing it inside a box, and then removing the papers one by one until the desired volume is filled out.
In addition, to ensure the correctness of using simple randomization, besides the previous method, randomization production software was used.
  Random Allocation Software
Producing the random sequence: besides the above methods run, online website - WWW.Randomization.com – was used as well.
In order to hide the random assignment, one of its methods called the central randomization was used where the random sequence method was used. The researcher contacted the relevant center according to the order of entry of the participants to the study and asked questionsabout the random assignment of the participants. For selecting the sample, 30 children - boys and girls - aged 6-8 years old with a mean age of 7 years, were selected with cerebral palsy diagnosis of paraplegia type and mild to moderate monoplegia and then the sample group was randomly divided into two groups of 15 as control and experimental group, Blinding description: Only the main researcher who was involved in the intervention, among the other two researchers, knew which participant received which intervention. Thus, single-blind method was used and given the age and the IQ of the children and considering the ethical principles, a brief explanation of the game was given regard the game.However, the principal of the center, the maternity clinic and the center-based pediatrician were kept blind relative to the study groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Internalization and extrapolation behavioral problems.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The sessions of the experimental, groups were held in 16 sessions (12 individual sessions and 4 group sessions), for 45 minutes and twice a week done by the researcher.Thechild-centered intervention approach where the child managed the therapy-session and the therapist was as the facilitatorusing different classificationsof toys given to the children.They help the child to gain an insight of themselves, self-control and appropriate emotional outburst. Intervention 2: Control group: they received no child-centered game therapy intervention and receivedroutine care along no additional work.The researcher also committed to the intervention for the control group at the end of the intervention period and, if it is effective, and if desired, the 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 After negotiations with the center and all the factors involved in the research will be undertaken</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Samira Vakili</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad University of Science and Research Branch - Shahdia Hesarak Blvd - University Square - End of Shahid Sattari Highway - Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۴۷۷۸۹۳۸۵۵</zip>
        <telephone>+98 21 4486 5154</telephone>
        <email>Samiravkl@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sogand Ghasemzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran - End of Shahid Sattari Highway - University Square - Shahdia Hesarak Blvd - Islamic Azad University of Science and Research Branch</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۴۷۷۸۹۳۸۵۵</zip>
        <telephone>+98 21 4486 5154</telephone>
        <email>S.ghasemzadeh@ut.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Children aged 6-8 years, the existence of emotional and behavioral problems based on Child Behavior Checklist
Interest in cooperation and participation in research based on the written consent of the legal guardian
IQ is above 55 (based on the information recorded in the medical records available at the center) the lowest IQ is 55 and the highest is 70 and the average IQ is 62.5
No treatments other than medication
The ability to use language and speech,
Inserting the cerebral palsy injury in the medical file,
The relative ability for using hands in the game according to the type of injury stated in the medical file and possibility of using evaluations like muscle tonicity, the growth of reflexes, status evaluation and movement of the daily activities recorded in the occupational therapy file</inclusion_criteria>
      <agemin>6 years</agemin>
      <agemax>8 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Uncontrollable aggression
absence for more than twice a week
receiving other interventions at the time of study other than medication</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></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: The sessions of the experimental, groups were held in 16 sessions (12 individual sessions and 4 group sessions), for 45 minutes and twice a week done by the researcher.Thechild-centered intervention approach where the child managed the therapy-session and the therapist was as the facilitatorusing different classificationsof toys given to the children.They help the child to gain an insight of themselves, self-control and appropriate emotional outburst.</i_keyword>
      <i_keyword>Control group: they received no child-centered game therapy intervention and receivedroutine care along no additional work.The researcher also committed to the intervention for the control group at the end of the intervention period and, if it is effective, and if desired, the intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Child Behavior Checklist. Timepoint: Before the intervention, 3 months later and 6 months later. Method of measurement: Children behavioral behavior questionnaire in pre-test and post-test.</prim_outcome>
      <prim_outcome>Anxiety Score in Children's Behavioral Problems Questionnaire. Timepoint: Before the intervention, 3 months later and 6 months later. Method of measurement: Children behavioral behavior questionnaire in pre-test and post-test.</prim_outcome>
      <prim_outcome>Aggression Score in Children's Behavioral Problems Questionnaire. Timepoint: Before the intervention, 3 months later and 6 months later. Method of measurement: Children behavioral behavior questionnaire in pre-test and post-test.</prim_outcome>
      <prim_outcome>Breaking down Score in Children's Behavioral Problems Questionnaire. Timepoint: Before the intervention, 3 months later and 6 months later. Method of measurement: Children behavioral behavior questionnaire in pre-test and post-test.</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, Science and Research Branch</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-10-31</approval_date>
        <contact_name>Institutional Research Ethics Committee Islamic Azad University- Science and Research Branch</contact_name>
        <contact_address>Tehran - End of Shahid Sattari Highway - University Square - Shahdia Hesarak Blvd - Islamic Azad University of Science and Research Branch Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
