<?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>IRCT20220214054020N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-05-14</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>"Effect of sensory diet on attention deficit/ hyperactivity"</public_title>
      <acronym>Attention Deficit Hyperactivity Disorder= ADHD</acronym>
      <scientific_title>Development of a family- based sensory diet program on attention deficit, hyperactivity and impulsivity in elementary school students with attention deficit hyperactivity disorder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-02-25</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/61984</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: For simple randomization at sealedenvelope.com, the Simple Randomization Services section enters the research information, including the intervention description, sample size, and the researcher's e-mail address, which is issued a password for the research. The names of the samples are entered in the patient's field to perform the research and a random request is made from the site, and the site randomly places the sample in group A or B and sends the result to the researcher's email.</study_design>
      <phase>3</phase>
      <hc_freetext>Attention deficit/hyperactivity Disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Family-Based Sensory Diet: This program  bases on the Wilberger (2018) treatment protocol and is a comprehensive sensory approach to treating sensory processing problems. This theory, officially known as the technique of deep pressure, deep sense and mouth touch, helps to organize the mind, brain and body and increases attention, participation in daily activities, reduces tactile defense and increases body self-regulation. This protocol consists of three components: pulling the sensory brush to the body, compressing the joints, and sensory diet. Sensory diet is a set of sensory activities and inputs to the body and nervous system to maintain a person's level of arousal.Activities are selected according to the needs of the person and are included in his daily plan and increase the level of consciousness, increase the body's awareness about himself, the environment and others, attend activities, improve learning, play, sleep, interact with Peers and increase the level of efficiency. The intervention group will use 12 sessions of family-centered sensory diet program, 3 sessions per week and each session for 45 minutes, which was taken from Wilburger Sensory protocol. Intervention 2: control group:Since the children will be selected from rehabilitation centers and receive an occupational therapy program one or two sessions per week, it will not be ethically possible to eliminate occupational therapy. Occupational therapy routine includes attention and concentration exercises and structural activity exercises.</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 The individual identity of children with the disorder will not be revealed</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Mohammadparsa Azizi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad University Science and Research Branch, University Square, Shohada Hesarak Blvd., End of Shahid Sattari Highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1477893855</zip>
        <telephone>+98 21 4486 5179</telephone>
        <email>mp.azizi@srbiau.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Mohammadparsa Azizi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad University Science and Research Branch, University Square, Shohada Hesarak Blvd., End of Shahid Sattari Highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1477893855</zip>
        <telephone>+98 21 4486 5179</telephone>
        <email>mp.azizi@srbiau.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having a diagnosis of inattention and hyperactivity.
Having a natural consciousness.
Health of the visual and auditory system.</inclusion_criteria>
      <agemin>6 years</agemin>
      <agemax>12 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Family reluctance to participate in the study
Lack of cooperation of the child to participate in the study
Age conditions of the child outside the age range of 6-12 years</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F90</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Disturbance of activity and attention</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: Family-Based Sensory Diet: This program  bases on the Wilberger (2018) treatment protocol and is a comprehensive sensory approach to treating sensory processing problems. This theory, officially known as the technique of deep pressure, deep sense and mouth touch, helps to organize the mind, brain and body and increases attention, participation in daily activities, reduces tactile defense and increases body self-regulation. This protocol consists of three components: pulling the sensory brush to the body, compressing the joints, and sensory diet. Sensory diet is a set of sensory activities and inputs to the body and nervous system to maintain a person's level of arousal.Activities are selected according to the needs of the person and are included in his daily plan and increase the level of consciousness, increase the body's awareness about himself, the environment and others, attend activities, improve learning, play, sleep, interact with Peers and increase the level of efficiency. The intervention group will use 12 sessions of family-centered sensory diet program, 3 sessions per week and each session for 45 minutes, which was taken from Wilburger Sensory protocol.</i_keyword>
      <i_keyword>control group:Since the children will be selected from rehabilitation centers and receive an occupational therapy program one or two sessions per week, it will not be ethically possible to eliminate occupational therapy. Occupational therapy routine includes attention and concentration exercises and structural activity exercises.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Measuring the rate of change in attention deficit, hyperactivity and impulsivity scores. Timepoint: The intervention group will use 12 sessions of family-centered sensory diet program, 3 sessions per week and each session for 45 minutes, for one month from the beginning of the program. Method of measurement: Conners Behavior Scale of Parent Form.</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>Independent by researchers</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-06-24</approval_date>
        <contact_name>, Islamic Azad University, Science and Research Branch, Tehran</contact_name>
        <contact_address>No,92.,bagherkhan ST., satarkhan Ave Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
