<?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>IRCT20231019059769N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-12-07</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of computer learning and diary on the self-regulation and emotional adjustment in teenagers with attention deficit hyperactivity disorder</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of computer learning and diary on the self-regulation and emotional adjustment in teenagers with attention deficit hyperactivity disorder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-12-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/73309</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Factorial, Purpose: Education/Guidance, Randomization description: The random allocation of replacement blocks will be allocated in 6 blocks of 6 with the Random Allocation software according to the attached list. Thus, with the available sampling method, the patients who refer to Ibn Sina Hospital will be included in the study according to the entry criteria and according to the attached table. which is explained by G power, the first patient enters the intervention group according to the block of 6, the next 3 patients enter the control group, and the last two patients also enter the intervention group
It should be mentioned that the allocation is considered in the form of 6 blocks, in each block 3 patients will be in the intervention group and 3 patients will be in the control group, and it will continue up to 36 people, which will actually be 6 blocks of 6, Blinding description: The study is one-sided blind, the person analyzing the information does not have access to the separation of the control and intervention groups when checking the results of the pre- and post-questionnaires, so they do not know which group the results of the analysis belong to, but the researcher and the participant He knows that the intervention has been done for him. Therefore, in this way, the bias will be as much as possible.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Attention deficit hyperactivity disorder.</hc_freetext>
      <i_freetext>In addition to routine treatment, the intervention group will receive RIHACOM cognitive-rehabilitation interventions and event recording. Interventions will be carried out for patients using Rihakam cognitive-rehabilitation software for 10 sessions of 45 minutes for 5 weeks. During the first session, how to use the diary book and complete it, how to perform rehabilitation exercises will be taught. In these interventions, the response control module of Rihakam software will be used, which includes four stages: training warm-up, main test and cooling down. The first and second stages last 1 minute each, which is a response exercise based on the patient's attention. 90 seconds later, the main test begins. This test is based on mental performance and automatic adaptation of the software so that based on the reaction time, immediately after seeing the command variable of the software, the participant must click on the running exercise which is in Farsi language. Exercises are graded from 0 to 130 based on performance, so a higher score indicates better performance. In each session, the performance of the participant is saved in the software, and based on that training level, the next session begins. In the second and subsequent sessions, based on the person's performance in the previous session with the automatic evaluation of the device, the next steps are performed with different degrees of difficulty for the person. This work continues up to 10 sessions. During these 10 sessions and up to one month after the end of the intervention, the participants will be asked to express their emotional performance during the day in the form of a daily diary, including guidelines for use, goals, introduction of emotion, behavior and impulsive behavior. that these booklets will be collected and analyzed weekly. The main content of the booklet is in the form of tables, including columns such as days of the week, time and place of the event, and rows containing emotion-oriented behaviors such as verbal violence, behavioral violence, delaying the response to the stimulus, impulsive behavior, the will to complete the work, motivation. Starting work, smoking, using virtual space, etc. After the end of the interventions, these booklets will be completed and then collected by the participant as a follow-up tool for the patient..</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:
clinical report

When:
4month

To whom:
Research team

Conditions:
__

Where to obtain:
Conductor of the research project

How to obtain:
As needed refer to  analytic reports

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Ladan Zarshenas</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Zand Blvd Namazi square Nursing faculty</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۳۱۱۹-۷۱۹۳۶</zip>
        <telephone>+98 917 308 8285</telephone>
        <email>zarshenas@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Ladan Zarshenas</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Zand Blvd, Namazi Square, Nursing Faculty</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۳۱۱۹-۷۱۹۳۶</zip>
        <telephone>+98 917 308 8285</telephone>
        <email>zarshenas@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Adolescents from the age of 11 to 19 years with ADHD diagnosed by a specialist
Ability to read and write
Not having vision, hearing, muscle and physical problems
Not suffering from known concomitant diseases such as schizophrenia, autism, low IQ
Not using drugs according to the information received from parents
Family and patient satisfaction</inclusion_criteria>
      <agemin>11 years</agemin>
      <agemax>19 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Inability to read and write
Substance use
Having bipolar schizophrenia and autism</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F90.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Attention-deficit hyperactivity disorder, predominantly inattentive type</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In addition to routine treatment, the intervention group will receive RIHACOM cognitive-rehabilitation interventions and event recording. Interventions will be carried out for patients using Rihakam cognitive-rehabilitation software for 10 sessions of 45 minutes for 5 weeks. During the first session, how to use the diary book and complete it, how to perform rehabilitation exercises will be taught. In these interventions, the response control module of Rihakam software will be used, which includes four stages: training warm-up, main test and cooling down. The first and second stages last 1 minute each, which is a response exercise based on the patient's attention. 90 seconds later, the main test begins. This test is based on mental performance and automatic adaptation of the software so that based on the reaction time, immediately after seeing the command variable of the software, the participant must click on the running exercise which is in Farsi language. Exercises are graded from 0 to 130 based on performance, so a higher score indicates better performance. In each session, the performance of the participant is saved in the software, and based on that training level, the next session begins. In the second and subsequent sessions, based on the person's performance in the previous session with the automatic evaluation of the device, the next steps are performed with different degrees of difficulty for the person. This work continues up to 10 sessions. During these 10 sessions and up to one month after the end of the intervention, the participants will be asked to express their emotional performance during the day in the form of a daily diary, including guidelines for use, goals, introduction of emotion, behavior and impulsive behavior. that these booklets will be collected and analyzed weekly. The main content of the booklet is in the form of tables, including columns such as days of the week, time and place of the event, and rows containing emotion-oriented behaviors such as verbal violence, behavioral violence, delaying the response to the stimulus, impulsive behavior, the will to complete the work, motivation. Starting work, smoking, using virtual space, etc. After the end of the interventions, these booklets will be completed and then collected by the participant as a follow-up tool for the patient.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Self regulation. Timepoint: The effect of computer learning and diary on self-regulation and emotional adjustment before immediately and 1 month after the intervention. Method of measurement: Miler-brown self regulation Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Emotional adjustment. Timepoint: Effect of computerised learning and time diary on emotional adjustment before immediate and 1month after intervention. Method of measurement: Rabio Emotional adjustment Questionnaire.</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-10-28</approval_date>
        <contact_name>Ethics Committee of Nursing and Midwifery Faculties, Management and Medical Information - Shiraz Uni</contact_name>
        <contact_address>Shiraz town,  Shiraz University of Medical Sciences  Zand Blvd. Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
