<?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>IRCT20190204042612N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-02-08</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The effect of stories on children's sleep disorders</public_title>
      <acronym></acronym>
      <scientific_title>The effect of storytelling training for parents on sleep disorders of autistic children</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-01-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/37451</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: Participant groups consisted of a control and an intervention group. The intervention, teaching storytelling to parents, was performed in the intervention group, but the control group received no intervention, Randomization description: Blocked randomization.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Autism. Condition 2: Sleep Disorders.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Teaching storytelling therapy to parents in this group was done in 5 one-hour sessions. Initial introductions were made and the storytelling therapy class schedules, expectations and parental involvement were explained. First appropriate books for children with autism were introduced, including pictorial books with repetitive rhythms and letters that have short texts with simple stories. In the next step, relying on sound training and alphabet training techniques, a selected story was read aloud by the researcher for the parents. After ensuring trained parents’ skills, sessions continued by their participation and practice. During each session, participants were provided with the information needed to complete the next session assignments. Five selected short stories from storybooks for children with autism were color printed on A4 sheets and provided to the parents, and a story was practiced at each session. The first story introduces the main character which is a cat and where it lives. The second story, aimed at understanding and establishment of communication, introduces a family. The third story introduces the family members. The story continues with verbal and non-verbal skills, any use of verbal language, like saying “thank you”, “I know”, “yes” and non-verbal skills like whispers, touches like hand shaking on social encounters and tapping shoulders. The fourth story, aiming at identifying environmental factors, introduces rain. The final story is about sleep and observing sleeping and resting patterns, gets the child ready to sleep. First Session: At first, the researcher introduced herself to the members of the group after welcoming them. She explained about the training program and its content using a PowerPoint file. Parents were told that it is important to learn new skills with the help the researcher during the course and to express any questions they may have during the training. After introduction of other members, the first short story was read by the researcher in order to break the ice and create an intimate atmosphere. Parents were discussed with about the content of the first story while expressing the content in simple language with the necessary equipment. The session concluded after completing complementary activities, having a break, and explaining home activities. Second Session: After teaching definitions of storytelling and different kinds of sleep disorders, parents were asked to perform the second short story based on their similar experiences and problems were resolved. It was recommended to perform the short story in a safe, pleasant and attractive environment; with a third person, easy and indirect language; with manipulation and control, flexibility and variability. Third Session: At this session, the goals of the storytelling and its types were first described, and then a role from the third short story was given to each of the group members. After knowing their dialogues, each person read their own parts as anticipated during the story telling by the researcher and the story was read as a group. Strengthening listening skills were performed including nonverbal behaviors such as visual focus, maintaining the distance of the speaker, taking turns in the reading group, and answering others' questions. Fourth Session: The fourth short story card was taught and then the story was simply presented by the researcher. Evaluation of children's responses to three stories was performed by the researcher through question and answer with parents. The parents described a set of problems they had when reading a story to find a solution, and all the ideas were written on the classroom board, then solution were suggested by brainstorming. Fifth Session: Parents were remarked about the steps of storytelling at home before sleeping by showing the short story cards and following its performance, and repeating the steps by the researcher, if necessary. The fifth story was performed by a researcher in a reading aloud manner. Parents found more courage in performing roles. Intervention 2: The control group: Children whose parents were in the control group underwent routine treatments of the autism center.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammed Saheb Zamani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>6th Floor, Sattari Highway, University Square, Shohada Hesarak Blvd, Azad University Central Building.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1477893855</zip>
        <telephone>+98 21 4735 3201</telephone>
        <email>m_szamani@iautmu.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Saheb Zamani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sixth Floor, Azad University Central Building, Shohadaye Hesarak St., University Square, Sattari Highway, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1477893855</zip>
        <telephone>+98 21 4735 3201</telephone>
        <email>m_szamani@iautmu.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Participants must fully consent to participate in the study.
Children of parents participating in the study must be both boys and girls.
Studied children must have at least a parent.</inclusion_criteria>
      <agemin>7 years</agemin>
      <agemax>12 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Children with other known mental disorders
Parents’ and children’s lack of consent
Taking medications that affect sleep disorders</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F84.0</hc_code>
      <hc_code>G47</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Autistic disorder</hc_keyword>
      <hc_keyword>Sleep disorders</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Teaching storytelling therapy to parents in this group was done in 5 one-hour sessions. Initial introductions were made and the storytelling therapy class schedules, expectations and parental involvement were explained. First appropriate books for children with autism were introduced, including pictorial books with repetitive rhythms and letters that have short texts with simple stories. In the next step, relying on sound training and alphabet training techniques, a selected story was read aloud by the researcher for the parents. After ensuring trained parents’ skills, sessions continued by their participation and practice. During each session, participants were provided with the information needed to complete the next session assignments. Five selected short stories from storybooks for children with autism were color printed on A4 sheets and provided to the parents, and a story was practiced at each session. The first story introduces the main character which is a cat and where it lives. The second story, aimed at understanding and establishment of communication, introduces a family. The third story introduces the family members. The story continues with verbal and non-verbal skills, any use of verbal language, like saying “thank you”, “I know”, “yes” and non-verbal skills like whispers, touches like hand shaking on social encounters and tapping shoulders. The fourth story, aiming at identifying environmental factors, introduces rain. The final story is about sleep and observing sleeping and resting patterns, gets the child ready to sleep. First Session: At first, the researcher introduced herself to the members of the group after welcoming them. She explained about the training program and its content using a PowerPoint file. Parents were told that it is important to learn new skills with the help the researcher during the course and to express any questions they may have during the training. After introduction of other members, the first short story was read by the researcher in order to break the ice and create an intimate atmosphere. Parents were discussed with about the content of the first story while expressing the content in simple language with the necessary equipment. The session concluded after completing complementary activities, having a break, and explaining home activities. Second Session: After teaching definitions of storytelling and different kinds of sleep disorders, parents were asked to perform the second short story based on their similar experiences and problems were resolved. It was recommended to perform the short story in a safe, pleasant and attractive environment; with a third person, easy and indirect language; with manipulation and control, flexibility and variability. Third Session: At this session, the goals of the storytelling and its types were first described, and then a role from the third short story was given to each of the group members. After knowing their dialogues, each person read their own parts as anticipated during the story telling by the researcher and the story was read as a group. Strengthening listening skills were performed including nonverbal behaviors such as visual focus, maintaining the distance of the speaker, taking turns in the reading group, and answering others' questions. Fourth Session: The fourth short story card was taught and then the story was simply presented by the researcher. Evaluation of children's responses to three stories was performed by the researcher through question and answer with parents. The parents described a set of problems they had when reading a story to find a solution, and all the ideas were written on the classroom board, then solution were suggested by brainstorming. Fifth Session: Parents were remarked about the steps of storytelling at home before sleeping by showing the short story cards and following its performance, and repeating the steps by the researcher, if necessary. The fifth story was performed by a researcher in a reading aloud manner. Parents found more courage in performing roles.</i_keyword>
      <i_keyword>The control group: Children whose parents were in the control group underwent routine treatments of the autism center.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The percentage of children with Children's Sleep Habits Questionnaire score of above 45. Timepoint: Sleep disorder score before the start of the study and six weeks after the intervention. Method of measurement: Children's Sleep Habits Questionnaire (CSHQ).</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-10-28</approval_date>
        <contact_name>The Ethics Committee of Islamic Azad University, Tehran Medical Branch</contact_name>
        <contact_address>Central Islamic Azad University Organization, Shohada Hesarak Boulevard, University Square, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
