<?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>IRCT20240129060841N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-02-19</date_registration>
      <primary_sponsor>University of social welfare and rehabilitation sciences</primary_sponsor>
      <public_title>The Effectiveness of Brief Exposure-Based Intervention on Reducing Nighttime Fears in 4-8 Years Children</public_title>
      <acronym></acronym>
      <scientific_title>The Effectiveness of Brief Exposure-Based Intervention on Reducing Nighttime Fears in 4-8 Years Children</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-04-18</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>6</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/75228</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Education/Guidance.</study_design>
      <phase>N/A</phase>
      <hc_freetext>nighttime fears.</hc_freetext>
      <i_freetext>Intervention group: After the initial assessment, a training session will be held for parents. During this meeting, explanations about the intervention process are presented and the required forms and materials are provided to the parents. Also, in this session, the translated version of the book, which includes stories and instructions for playing each of the games, will be presented to the parents. These guidelines help ensure that all subjects play the games in similar ways. The intervention is implemented by parents during 8 weeks. So parents (father or mother) should read a part of the story of the book to the child every night or play one or more of the book games with the child. It is also recommended that parents spend at least 1.5 hours reading books or playing games every week. After the end of 8 weeks, parents must have finished the book at least 2 times. During this period, once a week, parents share their problems with the researcher in a phone call for 10-20 minutes. The intervention is provided by the book "Uncle Lightfoot: Flip that Switch". In 21 chapters, this book teaches 4 to 8-year-old children bedtime skills and reduces nighttime fears by presenting stories and teaching various games. At the end, explanations are provided for parents about how to play the book and its games. 5 psychological techniques are used in this book: 1) Modeling: in this method, learning skills occur through observing the activities of the child whose story is narrated. 2) Gradual exposure: the child is first exposed to scary stimuli in the book and then Gradually, this encounter occurs in reality. 3) Desensitization: Using this technique, the child learns to associate positive and pleasant activities and images with darkness. 4) cognitive behavioral techniques: these techniques lead to changing the child's way of thinking when faced with scary situations and stimuli. Also, the child learns more about darkness. 5) Reinforcement: By using a reward (for example, a courage necklace), the child's appropriate behaviors are strengthened. The story of the book is about a boy with nighttime fears. Each chapter of the book is a step towards reducing these fears, and the child in the story plays games with his family members. In each chapter, the client who uses this book, after facing their fear in the story, plays the game related to that chapter with the family.  Stories should be read to the child before bedtime. It is also recommended that games that require more movement be played 30 minutes to 1 hour before children's bedtime so as not to interfere with their sleep process. But other games can be played when the child is ready to sleep. Before playing each chapter of the book, parents should read the practical guide on how to play the game related to that chapter..</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:
All data can be shared

When:
The access period starts 6 months after the results are published

To whom:
People working in scientific and academic institutions and industry

Conditions:
-

Where to obtain:
Contact the researcher via email. (Zahra Nourian, email address: znourian2000@gmail.com)

How to obtain:
After checking the industrial or academic affiliation of the applicant, the request will be answered.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Nourian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 14, Moatamedi Alley, Dollat Ave., Pasdaran Crossroad</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1945874154</zip>
        <telephone>+98 21 2258 4300</telephone>
        <email>zah.nourian@uswr.ac.ir</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Nourian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 14, Moatamedi Alley, Dollat Ave., Pasdaran Crossroad</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1945874154</zip>
        <telephone>+98 21 2258 4300</telephone>
        <email>zah.nourian@uswr.ac.ir</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The child's at the beginning of the treatment should be 4 to 8 years
Fear, anxiety, and avoidance should be constant and repeated and at least 6 months have passed since the child's fears started
According to the parents, fear and anxiety harm the performance of the child and the family
The child should avoid sleeping alone due to nighttime fears
The child and parents should have a complete command of the Persian language</inclusion_criteria>
      <agemin>4 years</agemin>
      <agemax>8 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The child is currently receiving medication or psychotherapy for nighttime fears or other internalizing problems
The child has major health, neuro-developmental, and psychological problems that need treatment
Parents are illiterate or unable to read</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F93.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Phobic anxiety disorder of childhood</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: After the initial assessment, a training session will be held for parents. During this meeting, explanations about the intervention process are presented and the required forms and materials are provided to the parents. Also, in this session, the translated version of the book, which includes stories and instructions for playing each of the games, will be presented to the parents. These guidelines help ensure that all subjects play the games in similar ways. The intervention is implemented by parents during 8 weeks. So parents (father or mother) should read a part of the story of the book to the child every night or play one or more of the book games with the child. It is also recommended that parents spend at least 1.5 hours reading books or playing games every week. After the end of 8 weeks, parents must have finished the book at least 2 times. During this period, once a week, parents share their problems with the researcher in a phone call for 10-20 minutes. The intervention is provided by the book "Uncle Lightfoot: Flip that Switch". In 21 chapters, this book teaches 4 to 8-year-old children bedtime skills and reduces nighttime fears by presenting stories and teaching various games. At the end, explanations are provided for parents about how to play the book and its games. 5 psychological techniques are used in this book: 1) Modeling: in this method, learning skills occur through observing the activities of the child whose story is narrated. 2) Gradual exposure: the child is first exposed to scary stimuli in the book and then Gradually, this encounter occurs in reality. 3) Desensitization: Using this technique, the child learns to associate positive and pleasant activities and images with darkness. 4) cognitive behavioral techniques: these techniques lead to changing the child's way of thinking when faced with scary situations and stimuli. Also, the child learns more about darkness. 5) Reinforcement: By using a reward (for example, a courage necklace), the child's appropriate behaviors are strengthened. The story of the book is about a boy with nighttime fears. Each chapter of the book is a step towards reducing these fears, and the child in the story plays games with his family members. In each chapter, the client who uses this book, after facing their fear in the story, plays the game related to that chapter with the family.  Stories should be read to the child before bedtime. It is also recommended that games that require more movement be played 30 minutes to 1 hour before children's bedtime so as not to interfere with their sleep process. But other games can be played when the child is ready to sleep. Before playing each chapter of the book, parents should read the practical guide on how to play the game related to that chapter.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The score of nighttime fears in the interview form with the child and the score of the child's Sleep Habits questionnaire. Timepoint: Before starting the intervention, measurement of nighttime fears will be done every 3 days. During the intervention, the interview form with the child will be administered every three days and the Sleep Habits questionnaire will be administered every seven days. Method of measurement: Child interview form and Child Sleep Habits Questionnaire.</prim_outcome>
      <prim_outcome>Self-efficacy in dealing with nighttime fears. Timepoint: It will be evaluated every 3 days before starting the intervention and every 7 days during the implementation of the intervention. Method of measurement: What My Child Can Do at Night in the Dark (Coffman, 1987).</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>University of social welfare and rehabilitation sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-01-24</approval_date>
        <contact_name>Ethics Committee in Research of University of Social Welfare and Rehabilitation sciences</contact_name>
        <contact_address>No. 14, Motammedi Alley, Dollat Ave., Pasdaran Crossroad Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
