<?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>IRCT20221016056196N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-11-09</date_registration>
      <primary_sponsor>Special Education Institutes, Bahawalpur Division</primary_sponsor>
      <public_title>Effectiveness of Community Based Rehabilitation (CBR) on Special Education Children</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness of Community Based Rehabilitation (CBR) on Quality of Life and Psychological Well-being of Children Enrolled in Special Education Institutes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-11-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>160</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/66348</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Supportive, Randomization description: For the generalizability of this study results, and to cover the area of Bahawalpur Division the multistage sampling technique will be used (Raver, Gershoff, &amp; Aber, 2007). Following steps will be employed to proceed:
Stage 1. Selection of strata (Institutes in city or tehsil). The population will break up into strata by Institutes of Special Education in city or tehsil in Bahawalpur District will be selected.
Stage 2. Selection of students from each sampled Institutes of Special Education.  On 2nd stage, total No. of students in selected strata will be identified and then enrolled special students will be selected from each category of disability as per proportion of students (see figure 2.2). 
Enrolled students of Special Education Institutes and their parents or caregivers from Bahawalpur District will be the part of this research.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Condition 1: Hearing Impaired Children. Condition 2: Visually Impaired Children. Condition 3: Physically Handicapped Children. Condition 4: Mentally Challenged Children.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Training and workshops on CBR strategies will be arranged for the experimental group. These workshops will be conducted at regular intervals of one week for the disabled children and their parents/caregivers. In these workshops, the experimental group will not only learn about the facilitative strategies for disabled children but also address the intervening issues. The procedure of CBR intervention will comprised of 3 months (12 weeks). Besides, the 128 members of the experimental group, children’s family members, and other community members will also be involved in these rehabilitation programs. Intervention 2: Control group: No any Intervention will be given to control group.</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:
Effectiveness of Community Based Rehabilitation (CBR) on Quality of Life and Psychological Well-being of Children Enrolled in Special Education Institutes

When:
starting 6 months after publication

To whom:
for academic institutions, community

Conditions:
Email id: areebawaseem5@gmail.com

Where to obtain:
Email Id: areebawaseemd@gmail.com

How to obtain:
Follow email address

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Areeba Ather Malik</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>House no 5/A, Awais Block, Sajid awan colony, Bahawalpur, Pakistan</address>
        <city>Bahawalpur</city>
        <country1>Pakistan</country1>
        <zip>63100</zip>
        <telephone>+92 345 5112494</telephone>
        <email>areebawaseemd@gmail.com</email>
        <affiliation>The Islamia University of Bahawalpur</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Areeba Ather Malik</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>House no. 5/A, Awais Block, Sajid Awan Colony, Bahawalpur, Pakistan</address>
        <city>Bahawalpur</city>
        <country1>Pakistan</country1>
        <zip>63100</zip>
        <telephone>+92 345 5112494</telephone>
        <email>areebawaseemd@gmail.com</email>
        <affiliation>The Islamia University of Bahawalpur</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Disabled children enrolled in special education institutes at mild levels with all the categories, i.e., physically disabled, hearing impaired, visually impaired, and mentally challenged.
Disabled children and their caregivers of all religions, genders, and socioeconomic status.
School-level disabled children.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>17 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>All other children with severe disabilities or no disabilities.
Disabled children above 17 years.
Children with mental disorders like schizophrenics, panic or mood disorders, etc.
Disabled children and their caregivers outside of the enrollment in special education institutes of Bahawalpur District.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>H90</hc_code>
      <hc_code>H54</hc_code>
      <hc_code>R29</hc_code>
      <hc_code>F70</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Conductive and sensorineural hearing loss</hc_keyword>
      <hc_keyword>Blindness and low vision</hc_keyword>
      <hc_keyword>Other symptoms and signs involving the nervous and musculoskeletal systems</hc_keyword>
      <hc_keyword>Mild intellectual disabilities</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: Training and workshops on CBR strategies will be arranged for the experimental group. These workshops will be conducted at regular intervals of one week for the disabled children and their parents/caregivers. In these workshops, the experimental group will not only learn about the facilitative strategies for disabled children but also address the intervening issues. The procedure of CBR intervention will comprised of 3 months (12 weeks). Besides, the 128 members of the experimental group, children’s family members, and other community members will also be involved in these rehabilitation programs.</i_keyword>
      <i_keyword>Control group: No any Intervention will be given to control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of Life (QoL) and Psychological Well-being. Timepoint: 3 months after intervention. Method of measurement: The Warwick-Edinburgh Mental Well-Being Scale (WEMWBS) to measure Psychological Well being, World Health Organization Quality of Life (WHOQOL) to measure Quality of Life (QoL).</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>Investigator Initiated</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-10-10</approval_date>
        <contact_name>Ethics Committee of The Islamia University of Bahawalpur</contact_name>
        <contact_address>The office of the Research, Innovation and Communication (ORIC), The Islamia University of Bahawalpur, Baghdad-ul-jadeed Campus Bahawalpur Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-10-10</approval_date>
        <contact_name>Ethics Committee of Department of Special Education</contact_name>
        <contact_address>District Education Officer, Special Education, Hasilpur Road, Bahawalpur Bahawalpur Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
