xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05998382</url>
    </required_header>
    <id_info>
      <org_study_id>February2023earthquakeinTurkey</org_study_id>
      <nct_id>NCT05998382</nct_id>
    </id_info>
    <brief_title>The Effect of Parent Mediated Intervention Program on Children With ASD Exposed to Earthquake in Turkey in February 2023</brief_title>
    <official_title>The Effect of Parent-Mediated Intervention Program on Children's Autism Symptoms, Behavioral Problems and Parents' Stress Level in Children With Autism Spectrum Disorder Exposed to Earthquake in Turkey in February 2023</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sabri Hergüner</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Herguner Therapy Private Clinic</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        After devastating natural events such as earthquakes, individuals with special needs&#xD;
        experience much more difficulties. There is a limited number of studies investigating the&#xD;
        impact of disasters on individuals with autism. Studies show that resilience and recovery of&#xD;
        pre-disaster functioning in young people with autism largely depends on their immediate&#xD;
        inclusion in routine, intensive rehabilitation programs and the stabilization of daily life&#xD;
        routines as much as possible. Children with autism had to interrupt their education due to&#xD;
        many reasons such as the destruction of special education centers due to the earthquake and&#xD;
        the temporary or permanent relocation of families to different cities. The fact that&#xD;
        individuals with autism stayed away from education after the earthquake caused parents'&#xD;
        stress and anxiety levels to increase. Parent involvement, a standard intervention practice&#xD;
        in ASD, shows that teaching intervention strategies to parents can improve children's&#xD;
        outcomes and increase parental effectiveness. Researchers aim in this study is to investigate&#xD;
        the effect of the online group-based parent-mediated intervention program on autism symptoms,&#xD;
        the effect on behavioral problems and the effect on parental mental health of children with&#xD;
        autism spectrum disorder whose education life was interrupted 8 months after the earthquake,&#xD;
        who had major changes in their lives (such as loss of relatives, loss of health, work, home,&#xD;
        anxiety, having to change cities ...).&#xD;
  &#xD;
        Online group-based intervention program ist designed to improve the interaction, play, speech&#xD;
        and learning skills of children with autism symptoms, taking into account the earthquake&#xD;
        conditions.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Earthquakes are considered to be destructive, uncontrollable natural disasters that cause the&#xD;
        most migration and threaten life the most. After the earthquake that occurred in L'Aquila,&#xD;
        the capital of Abruzzo region of Italy on April 2009, children and adolescents with autism&#xD;
        who were and were not exposed to the earthquake were followed up for 1 year in terms of&#xD;
        adaptation skills. It was observed that adaptive skills (communication, daily living skills,&#xD;
        socialization and motor skills) were clinically and statistically decreased one month after&#xD;
        the earthquake in individuals with autism exposed to the earthquake. Compared to the&#xD;
        unexposed group, adaptive skills were also found to be significantly lower. It was found that&#xD;
        adaptation skills were 30% lower in the 6th month of the earthquake compared to the beginning&#xD;
        and 15% lower in the 1st year.&#xD;
  &#xD;
        Studies show that the recovery of resilience and pre-disaster functions in young people with&#xD;
        autism largely depends on their immediate inclusion in routine, intensive rehabilitation&#xD;
        programs and fixation of daily life routines as much as possible. However, after the February&#xD;
        06, 2023 Kahramanmaraş earthquake, many rehabilitation centers where individuals with autism&#xD;
        received special education support were destroyed. This has made it difficult for individuals&#xD;
        with autism to access special education support. What we know about the impact of trauma in&#xD;
        children is that the response to traumatic events is mediated by caregivers and important&#xD;
        people in the child's life. The fact that individuals with autism stayed away from education&#xD;
        after the earthquake may cause parents' stress and anxiety levels to increase and their&#xD;
        ability to cope with trauma to be negatively affected, which may naturally cause individuals&#xD;
        with autism to be more affected by trauma.&#xD;
  &#xD;
        Parental involvement in intervention in Autism Spectrum Disorder (ASD) is a standard&#xD;
        intervention practice and research shows that teaching parents intervention strategies can&#xD;
        improve children's outcomes and increase parental effectiveness. Parent-mediated&#xD;
        interventions that are naturalistic, developmental and behavioral are effective in improving&#xD;
        social and communication skills for children with ASD.&#xD;
  &#xD;
        Learning that their child has ASD causes serious stress on families from the moment the&#xD;
        diagnosis is made. High levels of parental stress have been shown to negatively affect the&#xD;
        effectiveness of parent-mediated interventions (possibly due to interference with parental&#xD;
        learning). Therefore, it is important to determine intervention strategies by considering&#xD;
        parental stress in parent-mediated intervention programs.&#xD;
  &#xD;
        One of the challenges for parents and children with ASD is the limited access to education,&#xD;
        the costly nature of the education process, and sometimes the inability to make the necessary&#xD;
        arrangements for the family to benefit from education (such as caring for other children,&#xD;
        arranging work schedules). Online group-based trainings make it easier for families to&#xD;
        overcome these challenges. They can access education from their own homes, it is much more&#xD;
        cost-effective and it can be easier to make environmental arrangements. Group-based training&#xD;
        can also help families to support and learn from each other.&#xD;
  &#xD;
        The parent training program to be implemented is an online group-based intervention program&#xD;
        implemented by parents to improve the interaction, play, speech and learning skills of&#xD;
        children with autism symptoms. Through this program, families will be able to overcome the&#xD;
        time, place and economic difficulties that prevent them from accessing education, and since&#xD;
        it is a program implemented by parents, they will have the opportunity to apply it to&#xD;
        children in a natural environment throughout the day. It will also partially prevent families&#xD;
        from being away from education due to the destruction of education centers, relocation of&#xD;
        educators to different cities or inaccessibility due to reasons such as death. There are a&#xD;
        limited number of studies on the processes of readjustment of children with Autism Spectrum&#xD;
        Disorder to daily life after natural disasters such as earthquakes that cause serious losses.&#xD;
        There is no study on this theme conducted in Turkey.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>It will be realized with the participation of 24-72 months old children with autism spectrum disorder and their parents who were exposed to earthquake. The program will be announced via social media. After the applicants are evaluated, the families who will participate in the program will be given detailed information about the study and informed consent will be obtained. Before the training begins, families will be asked to fill out the Sociodemographic Data Form, Social Communication Checklist-Revised-Preschool Turkish Version, Depression Anxiety Stress Scale, ½-5 years old Child Behavior Checklist. Families will participate in the training program that will last 6 weeks. At the end of the 6th week, families will be asked to fill in the Social Communication Checklist-Revised-Preschool Turkish Version, Depression Anxiety Stress Scale, ½-5 years old Child Behavior Checklist Scale again. The change from time t1-baseline to time t2-6 weeks later was calculated by arithmetic method.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>change in autism symptom severity</measure>
      <time_frame>baseline and 6 weeks</time_frame>
      <description>Researcher examined the effect of intervention on autism symptom severity by using the change in Social Communication Checklist-Revised (SCC-R) scores. After the intervention program, whether there were significant changes in the total scores and subscales of Social Communication Checklist-Revised (SCC-R) was determined by the paired t test if it met the normal distribution conditions, and the Wilcoxon test if it did not meet the normal distribution conditions.Social Communication Checklist-Revised (SCC-R): The SCC-R is a 70-item checklist.They are summed for domain scores and a Total Score. Respondents indicate whether a child uses each skill, &quot;Rarely/Not Yet (1),&quot; &quot;Sometimes, but not consistently (2),&quot; or &quot;Usually, at least 75% of the time (3)&quot;. The total score would then be between 70 and 215. An increase in the Total Score means that social communication skills have increased.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>change in behavior problems</measure>
      <time_frame>baseline and 6 weeks</time_frame>
      <description>Researcher examined the effect of intervention on behaviour problems by using the change in 1/2-5 age Child Behavior Checklist- 1/2-5 CBCL) scores. After the intervention program, whether there were significant changes in the total scores and subscales of 1/2-5 Child Behavior Checklist was determined by the paired t test if it met the normal distribution conditions, and the Wilcoxon test if it did not meet the normal distribution conditions. 1/2-5 Child Behavior Checklist: CBCL 1.5-5 is a 99-item. The item is marked as 0 if the child does not have it, 1 if it is sometimes or somewhat true for the child, and 2 if it is very true or often true. An increase in total score means that behaviour problems is exacerbated.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>change in parental stress level</measure>
      <time_frame>baseline and 6 weeks</time_frame>
      <description>It was measured by the change in the Depression Anxiety Stress Scale After the intervention program, whether there were significant changes in the total scores and subscales of Depression Anxiety Stress Scale (DASS-21) was determined by the paired t test if it met the normal distribution conditions, and the Wilcoxon test if it did not meet the normal distribution conditions.DASS-21 contains 21 items and has 3 subscales: depression, stress and anxiety. It is a Likert-type scale. As the total score increases, the severity of depression, stress and anxiety increases.</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Autism Spectrum Disorder</condition>
    <condition>Earthquake</condition>
    <condition>Behavior Problem of Childhood and Adolescence</condition>
    <arm_group>
      <arm_group_label>intervention group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>There is only one group in the study. This group will participate in a 6-week online group-based parent-mediated intervention program.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Online group-based parent-mediated intervention program</intervention_name>
      <description>The program is an online group-based parent-mediated intervention program implemented in 2 sessions of 2 hours once a week for 6 weeks. In the first part of the weekly sessions, the topic of that week is explained to the parents. In the second part, videos recorded by the parents are watched and feedback is given to the parents. At the end of the session, written materials about that week's practices and homework are sent to the parents</description>
      <arm_group_label>intervention group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  The diagnosis of autism must be made by a specialist&#xD;
  &#xD;
            -  Being in the age range of 24-72 months&#xD;
  &#xD;
            -  Living in one of the 10 provinces where the earthquake was felt intensely during the&#xD;
               earthquake&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Having a genetic disease&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>24 Months</minimum_age>
      <maximum_age>72 Months</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Sabri Hergüner, Assoc.</last_name>
      <role>Study Director</role>
      <affiliation>Hergüner Therapy Privat Clinic</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Sabri Hergüner, Assoc.</last_name>
      <phone>+905337428150</phone>
      <email>sabriherguner@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Sümeyra Fırat, specialist</last_name>
      <phone>+905449765255</phone>
      <email>drsumeyrafirat@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Hergüner Therapy Private Clinic</name>
        <address>
          <city>Ankara</city>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Herguner Therapy Private Clinic</investigator_affiliation>
      <investigator_full_name>Sabri Hergüner</investigator_full_name>
      <investigator_title>associate professor</investigator_title>
    </responsible_party>
    <keyword>Autism spectrum disorder;</keyword>
    <keyword>Social communication</keyword>
    <keyword>Behavior Problem</keyword>
    <keyword>Parent mediated intervention</keyword>
    <keyword>earthquake</keyword>
    <keyword>parental stress</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Autistic Disorder</mesh_term>
      <mesh_term>Autism Spectrum Disorder</mesh_term>
      <mesh_term>Child Development Disorders, Pervasive</mesh_term>
      <mesh_term>Problem Behavior</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>all collected IPD, all IPD that underlie results in a publication</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_info_type>Analytic Code</ipd_info_type>
      <ipd_time_frame>Data can be shared 6 months after the study is publish</ipd_time_frame>
      <ipd_access_criteria>Assoc. Prof. Dr. Sabri Hergüner will review the requests.</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05998382
  org study id: February2023earthquakeinTurkey
  nct id: NCT05998382
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  After devastating natural events such as earthquakes, individuals with special needs
        experience much more difficulties. There is a limited number of studies investigating the
        impact of disasters on individuals with autism. Studies show that resilience and recovery of
        pre-disaster functioning in young people with autism largely depends on their immediate
        inclusion in routine, intensive rehabilitation programs and the stabilization of daily life
        routines as much as possible. Children with autism had to interrupt their education due to
        many reasons such as the destruction of special education centers due to the earthquake and
        the temporary or permanent relocation of families to different cities. The fact that
        individuals with autism stayed away from education after the earthquake caused parents'
        stress and anxiety levels to increase. Parent involvement, a standard intervention practice
        in ASD, shows that teaching intervention strategies to parents can improve children's
        outcomes and increase parental effectiveness. Researchers aim in this study is to investigate
        the effect of the online group-based parent-mediated intervention program on autism symptoms,
        the effect on behavioral problems and the effect on parental mental health of children with
        autism spectrum disorder whose education life was interrupted 8 months after the earthquake,
        who had major changes in their lives (such as loss of relatives, loss of health, work, home,
        anxiety, having to change cities ...).
  
        Online group-based intervention program ist designed to improve the interaction, play, speech
        and learning skills of children with autism symptoms, taking into account the earthquake
        conditions.
  Earthquakes are considered to be destructive, uncontrollable natural disasters that cause the
        most migration and threaten life the most. After the earthquake that occurred in L'Aquila,
        the capital of Abruzzo region of Italy on April 2009, children and adolescents with autism
        who were and were not exposed to the earthquake were followed up for 1 year in terms of
        adaptation skills. It was observed that adaptive skills (communication, daily living skills,
        socialization and motor skills) were clinically and statistically decreased one month after
        the earthquake in individuals with autism exposed to the earthquake. Compared to the
        unexposed group, adaptive skills were also found to be significantly lower. It was found that
        adaptation skills were 30% lower in the 6th month of the earthquake compared to the beginning
        and 15% lower in the 1st year.
  
        Studies show that the recovery of resilience and pre-disaster functions in young people with
        autism largely depends on their immediate inclusion in routine, intensive rehabilitation
        programs and fixation of daily life routines as much as possible. However, after the February
        06, 2023 Kahramanmaraş earthquake, many rehabilitation centers where individuals with autism
        received special education support were destroyed. This has made it difficult for individuals
        with autism to access special education support. What we know about the impact of trauma in
        children is that the response to traumatic events is mediated by caregivers and important
        people in the child's life. The fact that individuals with autism stayed away from education
        after the earthquake may cause parents' stress and anxiety levels to increase and their
        ability to cope with trauma to be negatively affected, which may naturally cause individuals
        with autism to be more affected by trauma.
  
        Parental involvement in intervention in Autism Spectrum Disorder (ASD) is a standard
        intervention practice and research shows that teaching parents intervention strategies can
        improve children's outcomes and increase parental effectiveness. Parent-mediated
        interventions that are naturalistic, developmental and behavioral are effective in improving
        social and communication skills for children with ASD.
  
        Learning that their child has ASD causes serious stress on families from the moment the
        diagnosis is made. High levels of parental stress have been shown to negatively affect the
        effectiveness of parent-mediated interventions (possibly due to interference with parental
        learning). Therefore, it is important to determine intervention strategies by considering
        parental stress in parent-mediated intervention programs.
  
        One of the challenges for parents and children with ASD is the limited access to education,
        the costly nature of the education process, and sometimes the inability to make the necessary
        arrangements for the family to benefit from education (such as caring for other children,
        arranging work schedules). Online group-based trainings make it easier for families to
        overcome these challenges. They can access education from their own homes, it is much more
        cost-effective and it can be easier to make environmental arrangements. Group-based training
        can also help families to support and learn from each other.
  
        The parent training program to be implemented is an online group-based intervention program
        implemented by parents to improve the interaction, play, speech and learning skills of
        children with autism symptoms. Through this program, families will be able to overcome the
        time, place and economic difficulties that prevent them from accessing education, and since
        it is a program implemented by parents, they will have the opportunity to apply it to
        children in a natural environment throughout the day. It will also partially prevent families
        from being away from education due to the destruction of education centers, relocation of
        educators to different cities or inaccessibility due to reasons such as death. There are a
        limited number of studies on the processes of readjustment of children with Autism Spectrum
        Disorder to daily life after natural disasters such as earthquakes that cause serious losses.
        There is no study on this theme conducted in Turkey.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: It will be realized with the participation of 24-72 months old children with autism spectrum disorder and their parents who were exposed to earthquake. The program will be announced via social media. After the applicants are evaluated, the families who will participate in the program will be given detailed information about the study and informed consent will be obtained. Before the training begins, families will be asked to fill out the Sociodemographic Data Form, Social Communication Checklist-Revised-Preschool Turkish Version, Depression Anxiety Stress Scale, ½-5 years old Child Behavior Checklist. Families will participate in the training program that will last 6 weeks. At the end of the 6th week, families will be asked to fill in the Social Communication Checklist-Revised-Preschool Turkish Version, Depression Anxiety Stress Scale, ½-5 years old Child Behavior Checklist Scale again. The change from time t1-baseline to time t2-6 weeks later was calculated by arithmetic method.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: change in autism symptom severity
  time frame: baseline and 6 weeks
  description: Researcher examined the effect of intervention on autism symptom severity by using the change in Social Communication Checklist-Revised (SCC-R) scores. After the intervention program, whether there were significant changes in the total scores and subscales of Social Communication Checklist-Revised (SCC-R) was determined by the paired t test if it met the normal distribution conditions, and the Wilcoxon test if it did not meet the normal distribution conditions.Social Communication Checklist-Revised (SCC-R): The SCC-R is a 70-item checklist.They are summed for domain scores and a Total Score. Respondents indicate whether a child uses each skill, "Rarely/Not Yet (1)," "Sometimes, but not consistently (2)," or "Usually, at least 75% of the time (3)". The total score would then be between 70 and 215. An increase in the Total Score means that social communication skills have increased.
  measure: change in behavior problems
  time frame: baseline and 6 weeks
  description: Researcher examined the effect of intervention on behaviour problems by using the change in 1/2-5 age Child Behavior Checklist- 1/2-5 CBCL) scores. After the intervention program, whether there were significant changes in the total scores and subscales of 1/2-5 Child Behavior Checklist was determined by the paired t test if it met the normal distribution conditions, and the Wilcoxon test if it did not meet the normal distribution conditions. 1/2-5 Child Behavior Checklist: CBCL 1.5-5 is a 99-item. The item is marked as 0 if the child does not have it, 1 if it is sometimes or somewhat true for the child, and 2 if it is very true or often true. An increase in total score means that behaviour problems is exacerbated.
  measure: change in parental stress level
  time frame: baseline and 6 weeks
  description: It was measured by the change in the Depression Anxiety Stress Scale After the intervention program, whether there were significant changes in the total scores and subscales of Depression Anxiety Stress Scale (DASS-21) was determined by the paired t test if it met the normal distribution conditions, and the Wilcoxon test if it did not meet the normal distribution conditions.DASS-21 contains 21 items and has 3 subscales: depression, stress and anxiety. It is a Likert-type scale. As the total score increases, the severity of depression, stress and anxiety increases.
  arm group label: intervention group
  arm group type: Experimental
  description: There is only one group in the study. This group will participate in a 6-week online group-based parent-mediated intervention program.
  intervention type: Behavioral
  intervention name: Online group-based parent-mediated intervention program
  description: The program is an online group-based parent-mediated intervention program implemented in 2 sessions of 2 hours once a week for 6 weeks. In the first part of the weekly sessions, the topic of that week is explained to the parents. In the second part, videos recorded by the parents are watched and feedback is given to the parents. At the end of the session, written materials about that week's practices and homework are sent to the parents
  arm group label: intervention group
  criteria: 
  gender: All
  minimum age: 24 Months
  maximum age: 72 Months
  healthy volunteers: No
  last name: Sabri Hergüner, Assoc.
  role: Study Director
  affiliation: Hergüner Therapy Privat Clinic
  last name: Sabri Hergüner, Assoc.
  phone: +905337428150
  email: sabriherguner@gmail.com
  last name: Sümeyra Fırat, specialist
  phone: +905449765255
  email: drsumeyrafirat@gmail.com
  facility: 
  country: Turkey
  responsible party type: Sponsor-Investigator
  investigator affiliation: Herguner Therapy Private Clinic
  investigator full name: Sabri Hergüner
  investigator title: associate professor
  mesh term: Autistic Disorder
  mesh term: Autism Spectrum Disorder
  mesh term: Child Development Disorders, Pervasive
  mesh term: Problem Behavior
  sharing ipd: Yes
  ipd description: all collected IPD, all IPD that underlie results in a publication
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd info type: Analytic Code
  ipd time frame: Data can be shared 6 months after the study is publish
  ipd access criteria: Assoc. Prof. Dr. Sabri Hergüner will review the requests.