<?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>IRCT20201019049080N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-01-11</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Effectiveness Increasing parental involvement in the transfer process in CO-OP approach on motor-based occupational performance in 7 to 12 –year-old children with Specific Learning Disorders (SLD).</public_title>
      <acronym></acronym>
      <scientific_title>The effect of increasing parental involvement in the transfer process in CO-OP approach on motor-based trained and untrained occupational performance in 7 to 12 –year-old children with Specific Learning Disorders (SLD).</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-12-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/51729</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: A qualitative study will be conducted to design a guideline to increasing parental involvement in the transfer process in the CO-OP intervention, and given that the number of children receiving CO-OP intervention has been limited. In the qualitative phase for designing the guideline, if we do not have access to an enough amount of information, the CO-OP intervention will be presented to a number of children as pre-test and post-test without control group. And the parents of these children will be involved in the qualitative phase of the interview and the design of the intervention guide, Randomization description: Balanced (permuted) block randomization: In this method, the number of participants in each group is the same and the size of all blocks is equal. In this study, 8 blocks with 4 participants were assigned to the intervention group and 4 participants to the control group. In this study, there are two intervention groups, we define 6 modes for quadruple blocks and we define 6 cards. Given that the sample number is 20 participants, we select 5 of the above cards by replacement. Sample defined cards:
Intervention group (A), control group (B)
AABB-ABAB-BABA-BBAA-ABBA-BAAB, Blinding description: single blind:  Outcome assessor: The person or persons conducting the assessment are unaware of assigning participants to intervention and control groups.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Condition 1: Specific Learning Disorders. Condition 2: Disorder of written expression. Condition 3: Mathematics disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: CO-OP intervention with increasing parental involvement guideline. Over 12 individualized sessions (10 treatment and one pre and post test session), at the rate of one or two a week, each child will learn the Goal-Plan-Do-Check strategy and then apply it in learning to perform the target skills. Through guided discovery, the therapist will enable the child to discover the domain-specific strategies required for task performance. Verbalization, by both therapist and child, of discovered strategies will be used to guide performance and to promote strategy learning. Bridging techniques will be used to promote transfer and generalization. Treatments will be administered by qualified occupational therapists who will receive specific CO-OP training.  All treatment sessions will last approximately 60 minutes. This intervention will be done along with two sessions of direct teaching of the basic principles of the CO-OP approach to parents and practicing these principles during the child intervention sessions. Parents at home will then help the child with additional goals chosen by the child. And are present during the sessions and practice and observe a variety of guided detection methods as scheduled. Two parent training sessions last 60 minutes. And at the end of the child's educational sessions, the parents will review the session and learn for 15 minutes. Intervention 2: Control group: CO-OP intervention. Over 12 individualized sessions (10 treatment and one pre and post test session), at the rate of one or two a week, each child will learn the Goal-Plan-Do-Check strategy and then apply it in learning to perform the target skills. Through guided discovery, the therapist will enable the child to discover the domain-specific strategies required for task performance. Verbalization, by both therapist and child, of discovered strategies will be used to guide performance and to promote strategy learning. Bridging techniques will be used to promote transfer and generalization. Treatments will be administered by qualified occupational therapists who will receive specific CO-OP training.  All treatment sessions will last approximately 60 minutes.</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:
Part of the data, such as information about the main outcome or the like, can be shared.

When:
Access period starts 6 months after the results are published

To whom:
Occupational Therapist, and researcher in the Occupational therapy

Conditions:
Use the reported results for clinical work

Where to obtain:
Iran university of Medical Science, School of Rehabilitation Sciences, Occupational Therapy department

How to obtain:
The data and results of the study are available in the final version of the dissertation and are available at the Faculty of Rehabilitation.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Narges Shafaroodi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Maddadkaran St., Shahid Nazari St., Mother Square, Mirdamad Blvd, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, Iran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1545913487</zip>
        <telephone>+98 21 2222 7124</telephone>
        <email>shafarodi.n@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Malahat AkbarFahimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Maddadkaran St., Shahid Nazari St., Mother Square, Mirdamad Blvd, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, Iran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>158754391</zip>
        <telephone>+98 21 2222 2059</telephone>
        <email>malahatfahimi@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Children with an SLD diagnosis aged between 7 and 12 years old
Normal or correct to normal hearing and vision.
Sufficient language ability to communicate with and be understood during treatment.
Report at least 5 occupational performance problems.</inclusion_criteria>
      <agemin>7 years</agemin>
      <agemax>12 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>had other diagnosis or signs of neurological or neuromuscular disease.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F81.0</hc_code>
      <hc_code>F81.81</hc_code>
      <hc_code>F81.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Specific reading disorder</hc_keyword>
      <hc_keyword>Disorder of written expression</hc_keyword>
      <hc_keyword>Mathematics disorder</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: CO-OP intervention with increasing parental involvement guideline. Over 12 individualized sessions (10 treatment and one pre and post test session), at the rate of one or two a week, each child will learn the Goal-Plan-Do-Check strategy and then apply it in learning to perform the target skills. Through guided discovery, the therapist will enable the child to discover the domain-specific strategies required for task performance. Verbalization, by both therapist and child, of discovered strategies will be used to guide performance and to promote strategy learning. Bridging techniques will be used to promote transfer and generalization. Treatments will be administered by qualified occupational therapists who will receive specific CO-OP training.  All treatment sessions will last approximately 60 minutes. This intervention will be done along with two sessions of direct teaching of the basic principles of the CO-OP approach to parents and practicing these principles during the child intervention sessions. Parents at home will then help the child with additional goals chosen by the child. And are present during the sessions and practice and observe a variety of guided detection methods as scheduled. Two parent training sessions last 60 minutes. And at the end of the child's educational sessions, the parents will review the session and learn for 15 minutes.</i_keyword>
      <i_keyword>Control group: CO-OP intervention. Over 12 individualized sessions (10 treatment and one pre and post test session), at the rate of one or two a week, each child will learn the Goal-Plan-Do-Check strategy and then apply it in learning to perform the target skills. Through guided discovery, the therapist will enable the child to discover the domain-specific strategies required for task performance. Verbalization, by both therapist and child, of discovered strategies will be used to guide performance and to promote strategy learning. Bridging techniques will be used to promote transfer and generalization. Treatments will be administered by qualified occupational therapists who will receive specific CO-OP training.  All treatment sessions will last approximately 60 minutes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Motor-based occupational performance and satisfaction of performance in trained and untrained tasks. Timepoint: pre intervention- post intervention and two month after intervention (follow-up). Method of measurement: Canadian Occupational Performance Measure (COPM).</prim_outcome>
      <prim_outcome>Motor-based occupational performance in trained and untrained tasks. Timepoint: pre intervention- post intervention and two month after intervention (follow-up). Method of measurement: Performance Quality Rating Scale (PQRS).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Motor skills. Timepoint: Pre intervention, Post intervention. Method of measurement: Bruninks Oseretsky Test of Motor Proficiency Measure.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-08-23</approval_date>
        <contact_name>Iran University of Medical Sciences-Ethical Committee</contact_name>
        <contact_address>Maddadkaran St., Shahid Nazari St., Mother Square, Mirdamad Blvd, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
