<?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>IRCT20250308064990N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-05-06</date_registration>
      <primary_sponsor>Islamic Azad University - Ahvaz Branch</primary_sponsor>
      <public_title>Comparing the effectiveness of social stories and cognitive rehabilitation in children with high-functioning autism</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effectiveness of social stories and cognitive rehabilitation on social skills, executive functions, verbal and non-verbal communication skills and stereotypical behaviors of children with high-functioning autism</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-05-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/82497</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The statistical population is children with high-functioning autism in Isfahan, who will be selected through purposive sampling (based on research criteria) and then placed in the first and second experimental groups and the control group by simple random assignment, so that everyone has an equal chance of being selected, Blinding description: Since the placement of participants in each of the three groups is random, only the rehabilitation method used in that group will be described.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Impairment in social skills, executive functioning, communication skills, and stereotypical behaviors in children with high-functioning Autism Spectrum Disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Effectiveness of social stories: 12 social stories (one social story per session) will be recorded and played by the researcher, re-read, related pictures will be shown, and then acted out and questions will be asked to understand the situation. The stories will be explained to parents so that the necessary points can be observed in similar situations. This intervention will be carried out in 14 sessions, 60 minutes each, 2 sessions per week. Intervention 2: Intervention group 2: Effectiveness of cognitive rehabilitation: Emotion-based cognitive rehabilitation package, which teaches basic emotions to the individual at 10 different levels and provides feedback based on the individual's response. At the end of the session, the situations will be explained to the subject's parents. In each session, the subject will be asked questions about the content taught. This intervention will be carried out on the intervention group over 14 sessions of 60 minutes (three sessions per week). Intervention 3: Control group: Control group samples will 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
All data can potentially be shared after individuals have been anonymized.

When:
The access period begins 6 months after the publication of the results.

To whom:
All researchers working in academic and scientific institutions, specialists in psychology with related fields to the research topic, students, and researchers in this area.

Conditions:
Results and data of the research aimed at improving the living and social conditions of children with high-functioning autism

Where to obtain:
Specialized websites, reputable journals related to the research, and the email address of the researcher.

How to obtain:
After completing the research, presenting the final results, and defending it, the information will be published. Considering the time required for the publication of information, it will be accessible from reputable related information sources.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sara Masoumi Torkamani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Second floor, No. 622, Shahid Yazdani Alley, Kh. Vahid.</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8175945173</zip>
        <telephone>+98 31 3625 3666</telephone>
        <email>masoumis.1400@gmail.com</email>
        <affiliation>Islamic Azad University - Ahvaz Branch</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sara Masoumi Torkamani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Second floor, No. 622, Shahid Yazdani Alley, Kh. Vahid.</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8175945173</zip>
        <telephone>+98 31 3625 3666</telephone>
        <email>masoumis.1400@gmail.com</email>
        <affiliation>Islamic Azad University - Ahvaz Branch</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age between 6 to 11 years.
Having an intelligence quotient higher than average.
High-functioning autism diagnosis based on the assessment of therapists at counseling centers.
Lack of sensory deficits such as deafness and blindness.
Informed consent and willingness to cooperate of children and their families.</inclusion_criteria>
      <agemin>6 years</agemin>
      <agemax>11 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Receiving simultaneous rehabilitation
Absence for more than two sessions.
Undergoing medical and psychiatric treatments that intervene in the educational process.</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>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: Effectiveness of social stories: 12 social stories (one social story per session) will be recorded and played by the researcher, re-read, related pictures will be shown, and then acted out and questions will be asked to understand the situation. The stories will be explained to parents so that the necessary points can be observed in similar situations. This intervention will be carried out in 14 sessions, 60 minutes each, 2 sessions per week.</i_keyword>
      <i_keyword>Intervention group 2: Effectiveness of cognitive rehabilitation: Emotion-based cognitive rehabilitation package, which teaches basic emotions to the individual at 10 different levels and provides feedback based on the individual's response. At the end of the session, the situations will be explained to the subject's parents. In each session, the subject will be asked questions about the content taught. This intervention will be carried out on the intervention group over 14 sessions of 60 minutes (three sessions per week).</i_keyword>
      <i_keyword>Control group: Control group samples will not receive any intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Social Skills. Timepoint: Measuring social skills before the start of the intervention and measurement after the completion of 14 intervention sessions on the effectiveness of social stories and cognitive rehabilitation on two intervention groups. Method of measurement: Bellini and Hopf's Social Skills Profile of Autism.</prim_outcome>
      <prim_outcome>Executive Functioning. Timepoint: Measuring executive functioning before the start of the intervention and measurement after the completion of 14 intervention sessions on the effectiveness of social stories and cognitive rehabilitation on two intervention groups. Method of measurement: Brief Executive Functions Questionnaire.</prim_outcome>
      <prim_outcome>Verbal and Nonverbal Communication Skills. Timepoint: Measuring verbal and nonverbal communication skills before the start of the intervention and measurement after the completion of 14 intervention sessions on the effectiveness of social stories and cognitive rehabilitation on two intervention groups. Method of measurement: Bishop's Children's Communication Checklist.</prim_outcome>
      <prim_outcome>Stereotypical Behaviors. Timepoint: Measuring Stereotypical Behaviors before the start of the intervention and measurement after the completion of 14 intervention sessions on the effectiveness of social stories and cognitive rehabilitation on two intervention groups. Method of measurement: Gilliam Autism Rating.</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 - Ahvaz Branch</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-12-27</approval_date>
        <contact_name>Ethics Committee of Islamic Azad University - Ahvaz Branch</contact_name>
        <contact_address>Faculty of Nursing and Midwifery, Islamic Azad University, Ahvaz Branch, Farhang Shahr Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
