<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/NCT04409106</url>
  </required_header>
  <id_info>
    <org_study_id>2020/5</org_study_id>
    <nct_id>NCT04409106</nct_id>
  </id_info>
  <brief_title>The Turkish Version of the Parental Smartphone Use Management Scale (PSUMS)</brief_title>
  <official_title>The Reliability and Validity of the Turkish Version of the Parental Smartphone Use Management Scale (PSUMS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istanbul University - Cerrahpasa (IUC)</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istanbul University - Cerrahpasa (IUC)</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Parental Smartphone Use Management Scale (PSUMS) was originally developed in English language&#xD;
      to parents to educate adolescents and communicate with them about online behavior and safety,&#xD;
      as well as to conduct plans to manage adolescents' internet and smartphone use. The purpose&#xD;
      of this study was to translate and cross-culturally adapt the PSUMS.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Parental Smartphone Use Management Scale (PSUMS) was originally developed in English language&#xD;
      to parents to educate adolescents and communicate with them about online behavior and safety,&#xD;
      as well as to conduct plans to manage adolescents' internet and smartphone use. The purpose&#xD;
      of this study was to translate and cross-culturally adapt the PSUMS. The study will include&#xD;
      adults who have been using smartphones for at least the past month and have children aged&#xD;
      11-18. For cross-cultural adaptation, two bi-lingual translators used the back-translation&#xD;
      procedure. Within a 5-to-7 day period after first assessment, the participants completed the&#xD;
      Turkish version of the Parental Smartphone Use Management Scale (PSUMS) to evaluate&#xD;
      test-retest reliability. Cronbach's alpha (α) was used to assess internal consistency. The&#xD;
      correlations with the Turkish version of The Smart Phone Addiction Scale-Short Form for&#xD;
      Adolescent and the Turkish version of PedsQL in Adolescents 13-18 years old will determine to&#xD;
      check the validity.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 10, 2020</start_date>
  <completion_date type="Actual">February 10, 2021</completion_date>
  <primary_completion_date type="Actual">October 1, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Parental Smartphone Use Management Scale (PSUMS)</measure>
    <time_frame>Baseline (First assessment)</time_frame>
    <description>Prior to developing the PSUMS, an item pool was established by conducting a literature review and a focus group. The item pool contained 18 items. A 7-point Likert scale was used to rate the level of agreement with items, ranging from 0 (no efficacy at all) to 6 (very strong efficacy).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Parental Smartphone Use Management Scale (PSUMS)</measure>
    <time_frame>Within a 5-to-7-day period after the first assessment (Second assessment)</time_frame>
    <description>Prior to developing the PSUMS, an item pool was established by conducting a literature review and a focus group. The item pool contained 18 items. A 7-point Likert scale was used to rate the level of agreement with items, ranging from 0 (no efficacy at all) to 6 (very strong efficacy).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Smartphone Addiction Scale -Short form for adolescent Version (SAS-SF)</measure>
    <time_frame>Baseline (First assessment)</time_frame>
    <description>Smartphone Addiction Scale -Short form for adolescent Version (SAS-SF) is a self-report scale with 10 items rated on a 6-point Likert scale (1= largely untrue, 6= largely true). Higher scores from the scale indicate higher level of the smartphone addiction. . The validity and reliability study of the questionnaire was done in Turkish.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PedsQL in Adolescents</measure>
    <time_frame>Baseline (First assessment)</time_frame>
    <description>It is a general quality of life scale that evaluates the physical and psychosocial lives of children between the ages of 11-18. The scale prepared for the 13-18 age group has a parent and child form. The parent form is filled out by the caregiver and the adolescent form by the child included in the study separately and simultaneously. The most important features are that &quot;PedsQL in adolescents&quot; is short, it can be filled in about 5-10 minutes, and it is easy to apply and score by the researcher.</description>
  </secondary_outcome>
  <enrollment type="Actual">200</enrollment>
  <condition>Addiction Psychological</condition>
  <condition>Addiction</condition>
  <condition>Adolescent</condition>
  <eligibility>
    <study_pop>
      <textblock>
        The sample will consist of parents who work at Istanbul University-Cerrahpaşa Faculty of&#xD;
        Health Sciences and voluntarily agree to participate in the study with children between&#xD;
        aged 11 and 18 years.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Working at Istanbul University-Cerrahpaşa Faculty of Health Sciences&#xD;
&#xD;
          -  Having children using smart phones for at least the last one month&#xD;
&#xD;
          -  Having children between aged 11 and 18 years.&#xD;
&#xD;
          -  Being a volunteer to participate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Having any serious vision problems or cognitive impairment&#xD;
&#xD;
          -  Having disabilities in understanding, speaking and reading Turkish&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ebru KAYA MUTLU, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Istanbul University - Cerrahpasa (IUC)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Istanbul University- Cerrahpasa</name>
      <address>
        <city>Istanbul</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <results_reference>
    <citation>Hsieh YP, Yen CF, Chou WJ. Development and Validation of the Parental Smartphone Use Management Scale (PSUMS): Parents' Perceived Self-Efficacy with Adolescents with Attention Deficit Hyperactivity Disorder. Int J Environ Res Public Health. 2019 Apr 21;16(8):1423. doi: 10.3390/ijerph16081423.</citation>
    <PMID>31010068</PMID>
  </results_reference>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>February 11, 2021</last_update_submitted>
  <last_update_submitted_qc>February 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Istanbul University - Cerrahpasa (IUC)</investigator_affiliation>
    <investigator_full_name>Ebru Kaya Mutlu, PT</investigator_full_name>
    <investigator_title>PT, PhD, Assoc Prof.</investigator_title>
  </responsible_party>
  <keyword>Smartphone use</keyword>
  <keyword>Parental management</keyword>
  <keyword>Scale validation</keyword>
  <keyword>Smartphone addiction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Behavior, Addictive</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04409106
org study id: 2020/5
nct id: NCT04409106
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Parental Smartphone Use Management Scale (PSUMS) was originally developed in English language
      to parents to educate adolescents and communicate with them about online behavior and safety,
      as well as to conduct plans to manage adolescents' internet and smartphone use. The purpose
      of this study was to translate and cross-culturally adapt the PSUMS.
Parental Smartphone Use Management Scale (PSUMS) was originally developed in English language
      to parents to educate adolescents and communicate with them about online behavior and safety,
      as well as to conduct plans to manage adolescents' internet and smartphone use. The purpose
      of this study was to translate and cross-culturally adapt the PSUMS. The study will include
      adults who have been using smartphones for at least the past month and have children aged
      11-18. For cross-cultural adaptation, two bi-lingual translators used the back-translation
      procedure. Within a 5-to-7 day period after first assessment, the participants completed the
      Turkish version of the Parental Smartphone Use Management Scale (PSUMS) to evaluate
      test-retest reliability. Cronbach's alpha (α) was used to assess internal consistency. The
      correlations with the Turkish version of The Smart Phone Addiction Scale-Short Form for
      Adolescent and the Turkish version of PedsQL in Adolescents 13-18 years old will determine to
      check the validity.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Parental Smartphone Use Management Scale (PSUMS)
time frame: Baseline (First assessment)
description: Prior to developing the PSUMS, an item pool was established by conducting a literature review and a focus group. The item pool contained 18 items. A 7-point Likert scale was used to rate the level of agreement with items, ranging from 0 (no efficacy at all) to 6 (very strong efficacy).
measure: Parental Smartphone Use Management Scale (PSUMS)
time frame: Within a 5-to-7-day period after the first assessment (Second assessment)
description: Prior to developing the PSUMS, an item pool was established by conducting a literature review and a focus group. The item pool contained 18 items. A 7-point Likert scale was used to rate the level of agreement with items, ranging from 0 (no efficacy at all) to 6 (very strong efficacy).
measure: Smartphone Addiction Scale -Short form for adolescent Version (SAS-SF)
time frame: Baseline (First assessment)
description: Smartphone Addiction Scale -Short form for adolescent Version (SAS-SF) is a self-report scale with 10 items rated on a 6-point Likert scale (1= largely untrue, 6= largely true). Higher scores from the scale indicate higher level of the smartphone addiction. . The validity and reliability study of the questionnaire was done in Turkish.
measure: PedsQL in Adolescents
time frame: Baseline (First assessment)
description: It is a general quality of life scale that evaluates the physical and psychosocial lives of children between the ages of 11-18. The scale prepared for the 13-18 age group has a parent and child form. The parent form is filled out by the caregiver and the adolescent form by the child included in the study separately and simultaneously. The most important features are that "PedsQL in adolescents" is short, it can be filled in about 5-10 minutes, and it is easy to apply and score by the researcher.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Ebru KAYA MUTLU, PhD
role: Principal Investigator
affiliation: Istanbul University - Cerrahpasa (IUC)
facility: 
country: Turkey
citation: Hsieh YP, Yen CF, Chou WJ. Development and Validation of the Parental Smartphone Use Management Scale (PSUMS): Parents' Perceived Self-Efficacy with Adolescents with Attention Deficit Hyperactivity Disorder. Int J Environ Res Public Health. 2019 Apr 21;16(8):1423. doi: 10.3390/ijerph16081423.
PMID: 31010068
responsible party type: Principal Investigator
investigator affiliation: Istanbul University - Cerrahpasa (IUC)
investigator full name: Ebru Kaya Mutlu, PT
investigator title: PT, PhD, Assoc Prof.
mesh term: Behavior, Addictive
sharing ipd: Undecided