<?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>IRCT20250723066608N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-06-26</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Intervention to Improve the Skills of Initiating and Maintaining the Topic of Conversation based on the Combination of Script Therapy and Normal Peer- Mediated Intervention Methods and Investigating its Effectiveness in Children with Autism Spectrum Disorder Level 1</public_title>
      <acronym></acronym>
      <scientific_title>Designing an Evaluation and Intervention Protocol to Improve the Skills of Initiating and Maintaining the Topic of Conversation based on the Combination of Script Therapy and Normal Peer- Mediated Intervention Methods and Investigating its Effectiveness in Children with Autism Spectrum Disorder Level 1</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2027-05-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>5</target_size>
      <recruitment_status>Pending</recruitment_status>
      <url>https://irct.ir/trial/90991</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Education/Guidance.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Level 1 autism spectrum disorder.</hc_freetext>
      <i_freetext>Intervention group: This study is conducted as a single subject design and there is no control group, in fact, each participant's performance is compared with himself. In the baseline phase, no intervention is carried out. In this phase, the participants' conversation initiation and maintenance skills are assessed three times to obtain a stable trend of their current performance and to serve as a basis for comparison for the intervention phase. In the intervention phase, participants undergo a combined prescription therapy and peer-mediated intervention. In the prescription therapy phase, written texts are used for training. In the peer-mediated intervention phase, normative peers act as models and facilitators in social interactions. This program consists of a three-month intervention that is implemented 3 times a week, each session lasting 45 minutes, in a controlled clinic environment.Assessment is performed using the assessment checklist developed in the first phase of this thesis at baseline, intervention, and treatment, and generalization of skills to new stimuli, new environments, and new people is also assessed after 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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Due to the small sample size of the study (Single-Subject Design with 5 participants), publishing individual participant data would pose a significant risk of deductive disclosure and compromise the participants' anonymity. Therefore, IPD will not be made publicly available</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Roya Mohammadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran - Intersection of Tous and Yadegar Imam Streets - Faghani Brothers Alley - Corner of Memarian Alley - Number 24 - Unit 3 - Bell 4</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1343916118</zip>
        <telephone>+98 939 084 6059</telephone>
        <email>royamohammadi895@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Roya Mohammadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ostad Moein, Tous Street, Faghani Brothers Alley, No. 24, Unit 3</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>134316118</zip>
        <telephone>+98 939 084 6059</telephone>
        <email>royamohammadi895@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Participant with autism spectrum disorder:
- According to the Gilliam Autism Severity Rating Scale, third edition (GARS-3), have a level 1 autism spectrum disorder
- Based on the demographic information questionnaire and date of birth, be between the ages of 8 and 15
- Has reached the level of academic skills and, according to the parent and teacher report, is literate and can read script.
- In terms of language skills, be at least at the advanced level of language, in other words, have a vocabulary of more than 50 words and an average length of utterance in words (MLUw) between 2 and 5
- Has difficulty in initiating and maintaining social interaction skills, as reported by parents and teachers
- The participant and his / her family must consent to participate in the research
Peer participants:
- Based on the demographic information questionnaire and date of birth, be between the ages of 8 and 15
- Be of the same sex as the participant with autism spectrum disorder (this will be determined in the third phase of the study, according to the selected participants. In fact, male participants will be matched with a male partner and female participants with a female partner)
- Has no prior knowledge of the participant with autism spectrum disorder
- Be interested in interacting with participants with autism spectrum disorder
- The participant and his / her family must consent to participate in the research.
- Be natural in the speech and language skills.
- Have reached the level of academic skills and are literate and able to follow the instructions and training necessary to implement interventions.</inclusion_criteria>
      <agemin>8 years</agemin>
      <agemax>15 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Participant with autism spectrum disorder: Presence of attention deficit hyperactivity disorder (ADHD) diagnosed by a psychiatrist
Peer participant: Diagnosis of other neurodevelopmental disorders such as ADHD diagnosed by a psychiatrist</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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: This study is conducted as a single subject design and there is no control group, in fact, each participant's performance is compared with himself. In the baseline phase, no intervention is carried out. In this phase, the participants' conversation initiation and maintenance skills are assessed three times to obtain a stable trend of their current performance and to serve as a basis for comparison for the intervention phase. In the intervention phase, participants undergo a combined prescription therapy and peer-mediated intervention. In the prescription therapy phase, written texts are used for training. In the peer-mediated intervention phase, normative peers act as models and facilitators in social interactions. This program consists of a three-month intervention that is implemented 3 times a week, each session lasting 45 minutes, in a controlled clinic environment.Assessment is performed using the assessment checklist developed in the first phase of this thesis at baseline, intervention, and treatment, and generalization of skills to new stimuli, new environments, and new people is also assessed after the intervention</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Score of topic Initiation of conversation. Timepoint: Before the start of the intervention - every month during the intervention - 4 and 8 weeks after the intervention. Method of measurement: Conversational skills assessment checklist.</prim_outcome>
      <prim_outcome>Score of Maintaining the Topic of Conversation. Timepoint: Before the start of the intervention - every month during the intervention - 4 and 8 weeks after the intervention. Method of measurement: Conversational skills assessment checklist.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Generalizing the topic initiation to non-instructional stimuli, new environments, and new people. Timepoint: after intervention. Method of measurement: Checklist for assessing the topic initiation and Topic Maintenance of conversation.</sec_outcome>
      <sec_outcome>Generalizing the topicMaintenance to non-instructional stimuli, new environments, and new people. Timepoint: after intervention. Method of measurement: Checklist for assessing the topic initiation and Topic Maintenance of conversation.</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>2025-05-25</approval_date>
        <contact_name>Ethics Committee of Iran University of Medical Sciences(IUMS)</contact_name>
        <contact_address>Tehran - Intersection of Tous and Yadegar Imam Streets - Faghani Brothers Alley - Corner of Memarian Alley - Number 24 - Unit 3 - Fourth Bell 24 Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
