<?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>IRCT20191101045298N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-03-05</date_registration>
      <primary_sponsor>Allameh Tabataba'i University</primary_sponsor>
      <public_title>The impact of the program of "Care for Child Development" on  child and caregivers</public_title>
      <acronym></acronym>
      <scientific_title>Adaptation of “Care for Child Development “ program based on response-to- intervention and evaluation of its effectiveness on development skills in at risk children and  Caregivers skills</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-04-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/44327</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Education/Guidance, Randomization description: In this study using Convenience Sampling, 50 children under the age of three years who were referred to Tabriz Comprehensive Center for Development were selected and divided randomly(simple randomization- random number table) into two experimental and control groups. reading the table is from top to bottom. even numbers are considered as intervention group and odd numbers are considered as control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Children  at Risk of Developmental Delay.</hc_freetext>
      <i_freetext>Intervention 1: This program is designed by the World Health Organization to empower caregivers. In this program, caregivers stand in need of three basic skills to make the optimum change in child: (1) Sensitivity: being aware of the child's movements, gestures and voice and interpreting it, (2) Responsiveness: responding in a timely manner and qualitatively to the child's signs and symptoms and (3) Learning enrichment and bonding.The number of sessions is four sessions.                                                                        first	: Introduction to program – Concept of development and its aspects - Factors affecting child development - Developmental delay - Child development monitoring.second: Who is caregiver and how can child care be maintained? - Essential skills to care for and improve child development (Sensitivity - Responsiveness and Enriching the Environment).third: Methods of stimulating and boosting child development - Concept and significance of communication - Communication methods - Importance of playing – Support strategies for child play by caregiver – Play things  - Types of toys for children.fourth: Play recommendation activities and communication through six age groups - Identifying obstacles and solutions given by program - Final monitoring of development. Intervention 2: The control group received routine care.</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:
Section of data

When:
Six months after publication

To whom:
Researchers

Conditions:
Research

Where to obtain:
Email

How to obtain:
after a week

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ali Bahari Gharehgoz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tabriz child development center north Tavanir bol., Valiasr , Tabriz, Iran</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166614766</zip>
        <telephone>+98 41 3326 3958</telephone>
        <email>a.bahari@atu.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ali Bahari Gharehgoz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tabriz child development center north Tavanir bol., Valiasr , Tabriz, Iran</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166614766</zip>
        <telephone>+98 41 3326 3958</telephone>
        <email>a.bahari@atu.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>children who are at Risk of Developmental Delay
Children in the range of 4 to 36 months</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>patient dissatisfaction
Neuro-developmental disorders</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F88</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other disorders of psychological development</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>This program is designed by the World Health Organization to empower caregivers. In this program, caregivers stand in need of three basic skills to make the optimum change in child: (1) Sensitivity: being aware of the child's movements, gestures and voice and interpreting it, (2) Responsiveness: responding in a timely manner and qualitatively to the child's signs and symptoms and (3) Learning enrichment and bonding.The number of sessions is four sessions.                                                                        first	: Introduction to program – Concept of development and its aspects - Factors affecting child development - Developmental delay - Child development monitoring.second: Who is caregiver and how can child care be maintained? - Essential skills to care for and improve child development (Sensitivity - Responsiveness and Enriching the Environment).third: Methods of stimulating and boosting child development - Concept and significance of communication - Communication methods - Importance of playing – Support strategies for child play by caregiver – Play things  - Types of toys for children.fourth: Play recommendation activities and communication through six age groups - Identifying obstacles and solutions given by program - Final monitoring of development</i_keyword>
      <i_keyword>The control group received routine care</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sensitivity and Responsiveness Skills- Development Skills. Timepoint: Before and After intervention. Method of measurement: The Social-Emotional Assessment/Evaluation Measure Family Profile - Maternal Caregiving Quality Scale -Age and Stages Questionnaires(ASQ)-Bayley.</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>Allameh Tabataba'i University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-01-07</approval_date>
        <contact_name>Tabriz University of Medical Sciences</contact_name>
        <contact_address>Golgasht Street Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
