<?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>IRCT20221128056651N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-12-21</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect of family-based sensory diet program with and without tele occupational therapy on sensory processing pattern, social competency and occupational performance of children with autism spectrum disorder</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of family-based sensory diet program with and without tele occupational therapy on sensory processing pattern, social competency and occupational performance of children with autism spectrum disorder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>32</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/67091</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The occupational therapist provides a pack of envelopes for the caregivers to choose a card from them. The arrangement of the cards will be random. Card A represents the intervention group and card B represents the control group, Blinding description: The initial and final tests will be done by another occupational therapist who is proficient in the tests.</study_design>
      <phase>N/A</phase>
      <hc_freetext>autism spectrum disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: receiving sensory diet through tele occupational therapy/                                                                                                                        In the first phase, the sensory diet intervention protocol is written for 4 sensory processing patterns. The samples in Tehran autism rehabilitation centers are divided into two groups: in-person and tele occupational therapy. In the second phase, The intervetions  are done during 8 weeks. (12 sessions/ each session: 30 minutes) the sessions of tele occupational therapy are in the form of video/audio conference. A special sensory diet is given to each child during the sessions. Families are taught the necessary things: awareness of their child's sensory pattern, its effect on behaviors, familiarization with how to perform activities and necessary environmental adaptations by the therapist, or watch videos with the therapist's explanation. Intervention 2: Control group: receiving sensory diet through face-to-face occupational therapy/                                                                                                             In the first phase, the sensory diet intervention protocol is written for 4 sensory processing patterns by expert panel. The samples in Tehran autism rehabilitation centers are divided into two groups: in-person and tele occupational therapy. In the second phase, The intervetions are done during 8 weeks. (12 sessions/ each session: 30 minutes) the sessions of in-person group are done in Tehran autism rehabilitation centers . A special sensory diet is given to each child during the sessions. Families are taught the necessary things: awareness of their child's sensory pattern, its effect on behaviors, familiarization with how to perform activities and necessary environmental adaptations by the therapist, or watch videos with the therapist's explanation.</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:
Part of the data, such as the information related to the main outcome or the like, can be shared by printing the article.

When:
The access period starts 6 months after the results are published

To whom:
The data will be available to researchers working in academic and scientific institutions and the families of clients.

Conditions:
Everyone has the right to submit a request.

Where to obtain:
Applicants can contact the researcher through E-mail.

How to obtain:
Immediately after receiving the e-mail and reviewing the applicant's request, possible information will be provided to him/her.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Navid Mirzakhani Araghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Beheshti Rehabilitation Faculty, infront of Bu Ali Hospital, Imam Hossein Square</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1983969411</zip>
        <telephone>+98 21 7754 2057</telephone>
        <email>Mirzakhany@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Simin Dehghani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>4th floor, No. 23, 6th street, Abuzar Ghafari Street, Khaje Abdullah, Shariati, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1661638175</zip>
        <telephone>+98 21 2286 9884</telephone>
        <email>siminotdehghani@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>diagnosis of autism spectrum disorder by a child psychiatrist and diagnosis of level one and two of autism spectrum disorder by an occupational therapist (Gilliam Autism Rating Scale, third edition)
age range: 4-10 years</inclusion_criteria>
      <agemin>4 years</agemin>
      <agemax>10 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>neurological disorders such as epilepsy and other psychiatric disorders</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: receiving sensory diet through tele occupational therapy/                                                                                                                        In the first phase, the sensory diet intervention protocol is written for 4 sensory processing patterns. The samples in Tehran autism rehabilitation centers are divided into two groups: in-person and tele occupational therapy. In the second phase, The intervetions  are done during 8 weeks. (12 sessions/ each session: 30 minutes) the sessions of tele occupational therapy are in the form of video/audio conference. A special sensory diet is given to each child during the sessions. Families are taught the necessary things: awareness of their child's sensory pattern, its effect on behaviors, familiarization with how to perform activities and necessary environmental adaptations by the therapist, or watch videos with the therapist's explanation.</i_keyword>
      <i_keyword>Control group: receiving sensory diet through face-to-face occupational therapy/                                                                                                             In the first phase, the sensory diet intervention protocol is written for 4 sensory processing patterns by expert panel. The samples in Tehran autism rehabilitation centers are divided into two groups: in-person and tele occupational therapy. In the second phase, The intervetions are done during 8 weeks. (12 sessions/ each session: 30 minutes) the sessions of in-person group are done in Tehran autism rehabilitation centers . A special sensory diet is given to each child during the sessions. Families are taught the necessary things: awareness of their child's sensory pattern, its effect on behaviors, familiarization with how to perform activities and necessary environmental adaptations by the therapist, or watch videos with the therapist's explanation.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sensory processing pattern. Timepoint: immediately before and after the intervention and one month after the intervention. Method of measurement: sensory profile 2 test.</prim_outcome>
      <prim_outcome>Social competency. Timepoint: Before and after the intervention and one month after the intervention. Method of measurement: Social Responsiveness Scale 2.</prim_outcome>
      <prim_outcome>Occupational performance. Timepoint: Before and after the intervention and one month after the intervention. Method of measurement: Canadian occupational Performance Measure.</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-11-22</approval_date>
        <contact_name>Ethics committee of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>Shahid Beheshti University of Medical Sciences, Next to Taleghani Hospital, Yaman Street Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
