<?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>IRCT20230919059472N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-10-01</date_registration>
      <primary_sponsor>Univeristy of Sahiwal</primary_sponsor>
      <public_title>Play Therapy improves attention and concentration of ADHD child</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness of Play Therapy to Improve Attention and Concentration of Attention Deficits Hyperactivity Disorder (ADHD) Children</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-05-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>10</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72736</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: The participant and data analyst do not know each other because the analyst sometimes adds their own queries to perfect results. The participant did not know they had skipped.Focus during therapy and not a proper outcome after the post-assessment.</study_design>
      <phase>1-2</phase>
      <hc_freetext>The children's condition are proper well..</hc_freetext>
      <i_freetext>Intervention 1: Intervention group name: experimental group; in the beginning, conduct a baseline assessment. The Conner teacher rating and Conner parent rating scales will be administered to determine the attention and concentration of ADHD children.After that, conduct play therapy. These sessions of play therapy increase the attention and concentration of ADHD children. The experimental group received 16 sessions, three of which were scheduled for 30 to 50 minutes.The baseline assessment is in the first session, then after 8 sessions of middle-line assessment, and lastly, in 16 sessions of post-line assessment. It will be typically conducted through one to one session. Purpose of play therapy intervention to improve attention and concentration of ADHD children. The post line assessment Conner Teacher and parent Rating scale after the intervention to evaluate the increase attention and concentration of ADHD children. Intervention 2: control group; The control group participant undergo the same base line assessment as the experimental group. Conner teacher and parent rating scale will be administrated to measured the attention and concentration of ADHD children. The control will not received the specific play therapy intervention. Just conduct the session will be engage into other activity to maintain attention and concentration , these session will be conduct 16 session three session on each week each session time 30 to 50 mints, then conduct the post line intervention assessment for the control group. This assessment will be included the same measured and assessment used as base line assessment to enhance attention and concentration. After the intervention comparison of both group to check the effect in attention and concentration among the participant of experimental group as compare to those in the 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:
The data will be collected and then analyzed through SPSS software and repeated ANOVA.

When:
ADHD children through different resources.

To whom:
The data will be collected at the School of Special Education, Sahiwal.

Conditions:
The inclusive and exclusive criteria will be used.

Where to obtain:
The date will be obtained through ADHD children.

How to obtain:
Through direct contact and mightily wish to interview the children, parents,and teachers separately.

Comments:
The overall procedure will be conducted with the treatment team.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr.Waseem Tufail,</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Farid Town Sahiwal ,Punjab, Pakistan</address>
        <city>Sahiwal</city>
        <country1>Pakistan</country1>
        <zip>57450</zip>
        <telephone>+92 345 8709195</telephone>
        <email>waseemtufail@uosahiwal.edu.pk</email>
        <affiliation>Univeristy of Sahiwal</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Muhammad Imran</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Farid Town Sahiwal ,Punjab, Pakistan</address>
        <city>Sahiwal</city>
        <country1>Pakistan</country1>
        <zip>57450</zip>
        <telephone>+92 345 8709195</telephone>
        <email>imranjoyia76@gmail.com</email>
        <affiliation>Univeristy of Sahiwal</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Both male and female will be add in this study .
The age range from 3to 14</inclusion_criteria>
      <agemin>3 years</agemin>
      <agemax>14 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>who use medication during treatment will not be included in this study.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F90.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Attention-deficit hyperactivity disorder, unspecified type</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group name: experimental group; in the beginning, conduct a baseline assessment. The Conner teacher rating and Conner parent rating scales will be administered to determine the attention and concentration of ADHD children.After that, conduct play therapy. These sessions of play therapy increase the attention and concentration of ADHD children. The experimental group received 16 sessions, three of which were scheduled for 30 to 50 minutes.The baseline assessment is in the first session, then after 8 sessions of middle-line assessment, and lastly, in 16 sessions of post-line assessment. It will be typically conducted through one to one session. Purpose of play therapy intervention to improve attention and concentration of ADHD children. The post line assessment Conner Teacher and parent Rating scale after the intervention to evaluate the increase attention and concentration of ADHD children.</i_keyword>
      <i_keyword>control group; The control group participant undergo the same base line assessment as the experimental group. Conner teacher and parent rating scale will be administrated to measured the attention and concentration of ADHD children. The control will not received the specific play therapy intervention. Just conduct the session will be engage into other activity to maintain attention and concentration , these session will be conduct 16 session three session on each week each session time 30 to 50 mints, then conduct the post line intervention assessment for the control group. This assessment will be included the same measured and assessment used as base line assessment to enhance attention and concentration. After the intervention comparison of both group to check the effect in attention and concentration among the participant of experimental group as compare to those in the control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Attention and concentration of ADHD children. Timepoint: The primary out come will be measured after 16 session of intervention. Method of measurement: Conner Teacher and Conner parent rating scale to measure the severity of ADHD children.</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>Material and other related things with treatment team</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-09-15</approval_date>
        <contact_name>Dr.Waseem Tufail, Dr. Saira Irfan ,Dr. Muhammad Imran</contact_name>
        <contact_address>Farid Town Sahiwal ,Punjab, Pakistan Sahiwal  Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
