<?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>IRCT201704247657N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-06-10</date_registration>
      <primary_sponsor>Tehran University of Medical Siences, Vice chancellor for research</primary_sponsor>
      <public_title>Efficacy of narrative-based language intervention on narrative production structures in cochlear implanted children</public_title>
      <acronym></acronym>
      <scientific_title>The investigation of efficacy of narrative-based language intervention (NBLI) on narrative production structures in Persian-speaking cochlear implanted children</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/8126</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Random-number table.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Hearing Loss.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Narrative Based Language Intervention is a kind of tell-story training program to children. It has four levels, consist of: warm up phase, story retelling stage, story generation stage, and repeated retelling tasks. Children will be received specific training, tasks, and practices in each levels of the intervention. Tasks of the intervention will be hierarchically easy to hard. Educational tasks will be presented in authentic and enjoyable context of book-reading and role-playing to children. Total duration of the educational intervention will be 2 months and educational 1-hourly lessons will be administered 3-times per week. Intervention 2: Control group: The conventional tasks of speech therapy will be utilized for tell-story training in control group. These tasks are consisting of: imitation of compound sentences, phrasing, incomplete sentences completion, and questions scaffolding about story.</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>Peyman Zamani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran, Enqelab Ave, Rehabilitation School, Dep. of Speech Therapy</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 7750 0687</telephone>
        <email>zamanipdrst@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences, Rehabilitation School, Dep. of Speech Therapy</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Peyman Zamani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran, Enqelab Ave, Rehabilitation School, Dep. of Speech Therapy</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 7750 0687</telephone>
        <email>zamanipdrst@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences, Rehabilitation School, Dep. of Speech Therapy</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria consist of: Pre-lingual profound sensory-neural hearing loss; unilateral cochlear implantation (CI) before aged 5 years; having the 22 processors CI prosthesis; using the hearing aid on contra-lateral ear; able to sentence production; to roll at least 1 year from cochlear implantation; orally Persian as the preferred language in children's family; aged between 5 to 17 years; having the Intelligence Quotient (IQ) ability in normal range; no known eyesight disorders; learning disabilities or co-morbidity such as Attention Deficit Hyperactive Disorder (ADHD); motor disorders; Mental Retardation (MR); autism; and so on; nonexistence of the history of narrative interventions; lack of the story-telling ability whether due to speech therapy or self-learning.&#13;
Exclusion criteria consist of: Family's or child's discontent to continue of the study; to be broken down the cochlear implant prosthesis for more than 2 weeks; to fall sick so that intervention process has to be disrupted for more than 3 weeks (except common colds).</inclusion_criteria>
      <agemin>5 years</agemin>
      <agemax>7 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>H90.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Sensorineural hearing loss, bilateral</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: Narrative Based Language Intervention is a kind of tell-story training program to children. It has four levels, consist of: warm up phase, story retelling stage, story generation stage, and repeated retelling tasks. Children will be received specific training, tasks, and practices in each levels of the intervention. Tasks of the intervention will be hierarchically easy to hard. Educational tasks will be presented in authentic and enjoyable context of book-reading and role-playing to children. Total duration of the educational intervention will be 2 months and educational 1-hourly lessons will be administered 3-times per week.</i_keyword>
      <i_keyword>Control group: The conventional tasks of speech therapy will be utilized for tell-story training in control group. These tasks are consisting of: imitation of compound sentences, phrasing, incomplete sentences completion, and questions scaffolding about story.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Frequency of Story Grammar. Timepoint: Before of Intervention, 2 months after Intervention, 2 months for follow up. Method of measurement: Questionnary of Language Sample Analaysis Test.</prim_outcome>
      <prim_outcome>Frequency of Main Information in Story. Timepoint: Before of Intervention, 2 months after Intervention, 2 months for follow up. Method of measurement: Questionnary of Language Sample Analaysis Test.</prim_outcome>
      <prim_outcome>Event Sequencing. Timepoint: Before of Intervention, 2 months after Intervention, 2 months for follow up. Method of measurement: Questionnary of Language Sample Analaysis Test.</prim_outcome>
      <prim_outcome>Frequency of Correct Clauses. Timepoint: Before of Intervention, 2 months after Intervention, 2 months for follow up. Method of measurement: Questionnary of Language Sample Analaysis Test.</prim_outcome>
      <prim_outcome>Frequency of Cohesive Markers. Timepoint: Before of Intervention, 2 months after Intervention, 2 months for follow up. Method of measurement: Questionnary of Language Sample Analaysis Test.</prim_outcome>
      <prim_outcome>Average of terminable-units Length. Timepoint: Before of Intervention, 2 months after Intervention, 2 months for follow up. Method of measurement: Questionnary of Language Sample Analaysis Test.</prim_outcome>
      <prim_outcome>Subordination Index. Timepoint: Before of Intervention, 2 months after Intervention, 2 months for follow up. Method of measurement: Questionnary of Language Sample Analaysis Test.</prim_outcome>
      <prim_outcome>Narrative Cohesion. Timepoint: Before of Intervention, 2 months after Intervention, 2 months for follow up. Method of measurement: Questionnary of Language Sample Analaysis Test.</prim_outcome>
      <prim_outcome>Accurracy Performance of Narrative. Timepoint: Before of Intervention, 2 months after Intervention, 2 months for follow up. Method of measurement: Questionnary of Language Sample Analaysis Test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>-. Timepoint: -. Method of measurement: -.</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_id>
        <sec_id>-</sec_id>
        <issuing_authority>-</issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Tehran University of Medical Siences, Vice chancellor for research</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-03-12</approval_date>
        <contact_name>Tehran University of Medical Sciences</contact_name>
        <contact_address>Tehran, Keshavarz Blv, Qods Ave, Markazi biulding, floor 6, Moavenat Pazuheshi Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
