<?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>IRCT20190505043477N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-10-31</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>"Narrative discourse intervention in children with autism"</public_title>
      <acronym></acronym>
      <scientific_title>The effect of narrative discourse intervention based on the Supporting Knowledge in Language and Literacy (SKILL) program on discourse production and reading comprehension abilities in children with autism spectrum disorders in elementary schools</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>24</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/41338</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Taking into account the dropout, 24 children with autism are assigned in one of the two treatment groups using random blocks. To randomize the size of blocks will be 4. According to the sample size of 24, which has been determined, 6 blocks will be produced using
 the online site (www.sealedenvelope.com). Group 1 received the Supporting Knowledge in Language and Literacy (SKILL) program and group 2 received the program of conventional speech therapy, Blinding description: At first, the people who analyzed the data learn about how to analyze data, Then, they are asked to analyze the per-treatment data. It should be noted that these people are unaware of the grouping of children, their demographic characteristics, the timing of the research, and the type of intervention received by each child. Subsequently, these individuals will be asked to analyze the post-treatment data.
The participants and their families are unaware of the compositions of the groups and do not visit each other during the trial sessions and outside the treatment environment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>َAutism spectrum disorders.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The group receiving the Supporting Knowledge in Language and Literacy (SKILL) program, the intervention is provided individually, 3 sessions per week, and 50 minutes each session by a speech and language pathologist. The intervention period is two months and the program is provided in 24 sessions. The intervention program  contains of three phases, phase 1: Teaching Story Structure and Causal Language, phase 2: Teaching Strategies for Creating a Situation Model, and phase 3: Teaching Strategies for Integration into Long Term Memory. The first phase of intervention consists of 17 lessons, the second phase is 11 lessons, and the third phase is 8 lessons. Intervention 2: Control group: The group receiving conventional speech therapy, the intervention is provided individually, 3 sessions per week, and 50 minutes each session by a speech and language pathologist. The intervention period is two months and the program is provided in 24 sessions. This  group of children with autism does not teach narratives intervention according to the SKILL program. They receive conventional speech therapy by 3 speech and language pathologists in centers and autism schools.</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 The effect of treatment is investigated in a group setting. Therefore individual data will not be published.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Soleymani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Speech Therapy, School of Rehabilitation, Tehran University of Medical Sciences, Pitch-e-shemiran,  Enghelab Ave., Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1148965141</zip>
        <telephone>+98 21 7753 5132</telephone>
        <email>Soleymaniz@sina.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Soleymani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Speech Therapy, School of Rehabilitation, Tehran University of Medical Sciences, Pitch-e-shemiran,  Enghelab Ave., Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1148965141</zip>
        <telephone>+98 21 7753 5132</telephone>
        <email>Soleymaniz@sina.tums.ac.ir</email>
        <affiliation>Tehran University of Medical 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>Be in the age range of 8 to 12 years
Be in the second to seventh grade of elementary schools
Have autism spectrum disorders; they have received a diagnosis of autism by a psychiatrist based on the DSM-V criteria and the diagnosis of autism should be supported by a speech and language pathologist using the GARS-2 questionnaire
Be monolingual and Persian language
Have be standard scores 70 and above on nonverbal portion of Wechsler Intelligence Test
Have be verbal fluent
Have be the ability to produce at least 100 spoken that is evaluated using the Farsi Narrative Norms Instrument guide Stories by speech and language pathologist
Have be the ability to sit behind the table and keep the attention
Have be the ability to decode words appropriate to age but weakness in reading comprehension; This is diagnosed by speech and language pathologists using reading and dyslexic tests (NEMA)</inclusion_criteria>
      <agemin>8 years</agemin>
      <agemax>12 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>If they have already received SKILL intervention program
Have be sensory damage (not compensated) for visual and auditory sensations
Have be neurological problems (epilepsy, cerebral palsy) and other psychiatric disorders except autism</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F84.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Autistic disorder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The group receiving the Supporting Knowledge in Language and Literacy (SKILL) program, the intervention is provided individually, 3 sessions per week, and 50 minutes each session by a speech and language pathologist. The intervention period is two months and the program is provided in 24 sessions. The intervention program  contains of three phases, phase 1: Teaching Story Structure and Causal Language, phase 2: Teaching Strategies for Creating a Situation Model, and phase 3: Teaching Strategies for Integration into Long Term Memory. The first phase of intervention consists of 17 lessons, the second phase is 11 lessons, and the third phase is 8 lessons.</i_keyword>
      <i_keyword>Control group: The group receiving conventional speech therapy, the intervention is provided individually, 3 sessions per week, and 50 minutes each session by a speech and language pathologist. The intervention period is two months and the program is provided in 24 sessions. This  group of children with autism does not teach narratives intervention according to the SKILL program. They receive conventional speech therapy by 3 speech and language pathologists in centers and autism schools.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The macrostructures of narrative discourse score. Timepoint: Before intervention and after intervention. Method of measurement: The Farsi Narrative Norms Instrument will be used to evaluate Narrative discourse production ability. The Monitoring Indicators of Scholarly Language will be used to obtain the macrostructures scores.</prim_outcome>
      <prim_outcome>The microstructures of narrative discourse score. Timepoint: Before intervention and after intervention. Method of measurement: The Farsi Narrative Norms Instrument will be used to evaluate Narrative discourse production ability. The Monitoring Indicators of Scholarly Language will be used to obtain the microstructures scores.</prim_outcome>
      <prim_outcome>Index of narrative complexity. Timepoint: Before intervention and after intervention. Method of measurement: The Farsi Narrative Norms Instrument will be used to evaluate Narrative discourse production ability. The Monitoring Indicators of Scholarly Language will be used to obtain the index of narrative speech complexity.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Reading comprehension score. Timepoint: Before intervention and after intervention. Method of measurement: The reading and dyslexic tests will be used to evaluate children’s reading ability and reading comprehension.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-07-25</approval_date>
        <contact_name>Ethcs committee of Tehran University of Medical Sciences.</contact_name>
        <contact_address>Adjutancy Chancellor for Research and Technology, Sixth Floor, Qods Ave., Keshavarz Blvd., Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
