<?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>IRCT20171219037954N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-01-08</date_registration>
      <primary_sponsor>Semnan University of Medical Sciences</primary_sponsor>
      <public_title>Cognitive Play Therapy on Anxiety in Children with Reading Learning Disorder</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Cognitive Therapy on Anxiety, Self-esteem, Social Behavioral Skills and Academic Self-Efficacy in Children with Reading Disabilities</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-12-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/28369</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Each of the schools in Semnan is given a number. Numbers are written on separate paper. Then the number of a school by lot is removed randomly. Each student with a valid entry criteria is also given a number. From one to fifteen in the intervention group and from sixteen to thirty in the control group. Then, each student number is randomly assigned to the lot by lot, Blinding description: In this way, the task is planned in such a way that the participant does not understand which of the two control or test groups belong.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Specific developmental disorders of scholastic skills.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Children with learning disabilities 8 to 12 years of age, in a 16-session program, 3 days a week for 45 minutes for participants in a group. Each group has 10-8 children. Therapeutic interventions designed for each treatment session: First session: Getting to know each other and explaining the principles of treating situations that disturb the child. Session 2: Review the previous session Helping the child to recognize different feelings and recognize the differentiation of anxiety Concerns about other feelings Child's recognition of body reactions to anxiety Start anxiety hierarchy designing - Session 3: Review the session Pre-recognition of the child's response Body Anxiety. Session Four: Encouraging Parents to Participate in a Therapeutic Plan and Creating Safe Children's Responses to Child and Parent's Questions. Session F: Reviewing the Anxiety Tip and Concerns in the Child. Familiarizing with the Methods of Attraction. Session Six: Explaining Thoughts. Negative Person and Their Impact on Anxiety Helps Identify Child's Insomnia During Anxiety Helps Positive / Relaxation Suggestions, Seventh Session: Self-Controversy and Problem-Solving Training, Eighth Session: Beginning A Practice in Tense Situations, Ninth Meeting: Second Meeting with Parents, Tenth Meeting: Facing the Child in Situations with Less Exposed Anxiety, Lesson 11: Exercise of the child in situations with less anxiety, Twelfth session: Facing the child in moderate anxiety situations, Thirteenth session: Exercise of the child in situations with moderate anxiety with tranquility, Session fourteen: Facing the child in 15th session of anxiety. Exercise of the child in situations with high anxiety with calm. Sixteenth session: generalize the skills learned to other environments. Intervention 2: Control group: Includes children with learning disabilities, aged 8-12 years, who benefit from routine and professional care services in rehabilitation centers.</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:
Reproductive in the field of rehabilitation and behavioral science

When:
One year

To whom:
researchers

Conditions:
Behavioral sciences and its effects

Where to obtain:
Semnan University of Medical Sciences

How to obtain:
Supervision of the Student Research Committee of Semnan University of Medical Sciences - fulfillment of main investigator's obligations

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mina sadat Mirshoja</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Damghan Road, Semnan University of Medical Sciences, Faculty of Rehabilitation</address>
        <city>semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3514799442</zip>
        <telephone>+98 23 3365 4180</telephone>
        <email>msj5831@yahoo.com</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>mina sadat mirshoja</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Damghan Road, Semnan University of Medical Sciences, Faculty of Rehabilitation</address>
        <city>semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3514799442</zip>
        <telephone>+98 23 3365 4180</telephone>
        <email>msj5831@yahoo.com</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>ages 12-8
children with reading disorder with diagnosis of a psychiatrist</inclusion_criteria>
      <agemin>8 years</agemin>
      <agemax>12 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The presence of learning disorder with other psychiatric disorders</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F81.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Specific reading disorder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Children with learning disabilities 8 to 12 years of age, in a 16-session program, 3 days a week for 45 minutes for participants in a group. Each group has 10-8 children. Therapeutic interventions designed for each treatment session: First session: Getting to know each other and explaining the principles of treating situations that disturb the child. Session 2: Review the previous session Helping the child to recognize different feelings and recognize the differentiation of anxiety Concerns about other feelings Child's recognition of body reactions to anxiety Start anxiety hierarchy designing - Session 3: Review the session Pre-recognition of the child's response Body Anxiety. Session Four: Encouraging Parents to Participate in a Therapeutic Plan and Creating Safe Children's Responses to Child and Parent's Questions. Session F: Reviewing the Anxiety Tip and Concerns in the Child. Familiarizing with the Methods of Attraction. Session Six: Explaining Thoughts. Negative Person and Their Impact on Anxiety Helps Identify Child's Insomnia During Anxiety Helps Positive / Relaxation Suggestions, Seventh Session: Self-Controversy and Problem-Solving Training, Eighth Session: Beginning A Practice in Tense Situations, Ninth Meeting: Second Meeting with Parents, Tenth Meeting: Facing the Child in Situations with Less Exposed Anxiety, Lesson 11: Exercise of the child in situations with less anxiety, Twelfth session: Facing the child in moderate anxiety situations, Thirteenth session: Exercise of the child in situations with moderate anxiety with tranquility, Session fourteen: Facing the child in 15th session of anxiety. Exercise of the child in situations with high anxiety with calm. Sixteenth session: generalize the skills learned to other environments</i_keyword>
      <i_keyword>Control group: Includes children with learning disabilities, aged 8-12 years, who benefit from routine and professional care services in rehabilitation centers.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Learning problems. Timepoint: 10 to 15 minutes. Method of measurement: Colorado Wilkat Learning Problems Questionnaire.</prim_outcome>
      <prim_outcome>Anxiety. Timepoint: 10 to 15 minutes. Method of measurement: Jink &amp; Morgan Academic Self-Efficacy Inventory.</prim_outcome>
      <prim_outcome>Behavioral problems. Timepoint: 10 to 15 minutes. Method of measurement: Rutter Behavioral Questionnaire Teacher Form.</prim_outcome>
      <prim_outcome>Anxiety. Timepoint: 10 to 15 minutes. Method of measurement: Spence Anxiety Inventory.</prim_outcome>
      <prim_outcome>Self-Esteem. Timepoint: 10 to 15 minutes. Method of measurement: Cooper Smith Self-Esteem Questionnaire.</prim_outcome>
      <prim_outcome>Social skills problems. Timepoint: 10 to 15 minutes. Method of measurement: Gersham and Elliot Social Skills Questionnaire.</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>Semnan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-12-12</approval_date>
        <contact_name>IR.SEMUMS.REC</contact_name>
        <contact_address>15 km Damghan Road- Semnan University of Medical Sciences- Faculty of Rehabilitation semnan Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
