<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/NCT03780088</url>
  </required_header>
  <id_info>
    <org_study_id>46142</org_study_id>
    <nct_id>NCT03780088</nct_id>
  </id_info>
  <brief_title>Improving Access to Care: Testing an Integrated Care Mobile Health Intervention</brief_title>
  <official_title>Improving Access to Care: Testing an Integrated Care Mobile Health Intervention to Improve Sleep and Mental Health in Adolescents</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, San Francisco</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This study aims to evaluate the feasibility, effectiveness, and dissemination potential of an&#xD;
      innovative strategy for improving access to effective sleep health care for adolescents. The&#xD;
      study will test an adaptation of the Transdiagnostic Sleep and Circadian Intervention&#xD;
      (TranS-C), a brief sleep intervention with demonstrated efficacy for improving sleep and&#xD;
      mental health outcomes in youth.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This adaptation is designed to address the following key challenges to accessing care: (1) to&#xD;
      overcome the challenge of low availability of qualified providers as a barrier to treatment&#xD;
      access, we have adapted TranS-C for online and mobile device delivery (referred to as&#xD;
      mTranS-C), thereby leveraging the high rates of mobile phone and internet use in adolescents;&#xD;
      (2) to further increase access we will disseminate mTranS-C within primary care services, a&#xD;
      proven strategy for improving access to behavioral health care; and (3) we focus on&#xD;
      low-income communities, where there is a higher prevalence of sleep problems and low access&#xD;
      to services.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 16, 2019</start_date>
  <completion_date type="Actual">April 15, 2021</completion_date>
  <primary_completion_date type="Actual">February 1, 2021</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pittsburgh Sleep Quality Index (PSQI)</measure>
    <time_frame>baseline to end of treatment (anticipated average exposure 2 months), and month 5</time_frame>
    <description>A validated questionnaire; total score range between 0 and 21, with higher numbers representing worse sleep quality.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient Health Questionnaire 9 (PHQ-9)</measure>
    <time_frame>baseline to end of treatment (anticipated average exposure 2 months), and month 5</time_frame>
    <description>A validated questionnaire measuring depressive symptom severity. The total score ranges between 0 and 19. Scores are rated as minimal (0-4), mild (5-9), moderate (10-14), and severe (15-19).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Strengths &amp; Difficulties Questionnaire (SDQ)</measure>
    <time_frame>baseline and at months 2 and 5</time_frame>
    <description>The Strengths and Difficulties Questionnaire (SDQ) is a validated 25 item behavioral screening questionnaire. Individual items are rated 'Somewhat True' (always scored as 1), 'Not True'(score is typically 0 except when reverse scored) and 'Certainly True' (score is typically 2 except when reverse scored). The SDQ comprise 5 scales (Prosocial, Peer Problems, Hyperactivity, Conduct and Emotional Problems) of 5 items each. For each of the 5 scales the score can range from 0 to 10 if all items were completed. These scores can be scaled up pro-rata if at least 3 items were completed, e.g. a score of 4 based on 3 completed items can be scaled up to a score of 7 (6.67 rounded up) for 5 items. A total difficulties score is generated by summing scores from all the scales except the prosocial scale. The resultant score ranges from 0 to 40, and is counted as missing of one of the 4 component scores is missing.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">52</enrollment>
  <condition>Insomnia</condition>
  <condition>Delayed Sleep Phase</condition>
  <arm_group>
    <arm_group_label>mTranS-C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Access to a mobile and computer accessible adaptation of Transdiagnostic Sleep and Circadian Intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>mTranS-C</intervention_name>
    <description>mobile health</description>
    <arm_group_label>mTranS-C</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age 12-18 years&#xD;
&#xD;
          -  a sleep health deficit&#xD;
&#xD;
          -  youth has access to a mobile phone or internet&#xD;
&#xD;
          -  youth is fluent in English.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  current use of medications or herbs with known effects on sleep&#xD;
&#xD;
          -  current substance use disorder&#xD;
&#xD;
          -  current suicidality/thoughts of death&#xD;
&#xD;
          -  thought disorder&#xD;
&#xD;
          -  unstable major medical conditions&#xD;
&#xD;
          -  current psychotherapy for sleep health deficits&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lauren Asarnow, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Gardner Packard Children's Health Center</name>
      <address>
        <city>Atherton</city>
        <state>California</state>
        <zip>94027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>December 17, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>August 13, 2021</last_update_submitted>
  <last_update_submitted_qc>August 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 17, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</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/NCT03780088
org study id: 46142
nct id: NCT03780088
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study aims to evaluate the feasibility, effectiveness, and dissemination potential of an
      innovative strategy for improving access to effective sleep health care for adolescents. The
      study will test an adaptation of the Transdiagnostic Sleep and Circadian Intervention
      (TranS-C), a brief sleep intervention with demonstrated efficacy for improving sleep and
      mental health outcomes in youth.
This adaptation is designed to address the following key challenges to accessing care: (1) to
      overcome the challenge of low availability of qualified providers as a barrier to treatment
      access, we have adapted TranS-C for online and mobile device delivery (referred to as
      mTranS-C), thereby leveraging the high rates of mobile phone and internet use in adolescents;
      (2) to further increase access we will disseminate mTranS-C within primary care services, a
      proven strategy for improving access to behavioral health care; and (3) we focus on
      low-income communities, where there is a higher prevalence of sleep problems and low access
      to services.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Pittsburgh Sleep Quality Index (PSQI)
time frame: baseline to end of treatment (anticipated average exposure 2 months), and month 5
description: A validated questionnaire; total score range between 0 and 21, with higher numbers representing worse sleep quality.
measure: Patient Health Questionnaire 9 (PHQ-9)
time frame: baseline to end of treatment (anticipated average exposure 2 months), and month 5
description: A validated questionnaire measuring depressive symptom severity. The total score ranges between 0 and 19. Scores are rated as minimal (0-4), mild (5-9), moderate (10-14), and severe (15-19).
measure: Strengths & Difficulties Questionnaire (SDQ)
time frame: baseline and at months 2 and 5
description: The Strengths and Difficulties Questionnaire (SDQ) is a validated 25 item behavioral screening questionnaire. Individual items are rated 'Somewhat True' (always scored as 1), 'Not True'(score is typically 0 except when reverse scored) and 'Certainly True' (score is typically 2 except when reverse scored). The SDQ comprise 5 scales (Prosocial, Peer Problems, Hyperactivity, Conduct and Emotional Problems) of 5 items each. For each of the 5 scales the score can range from 0 to 10 if all items were completed. These scores can be scaled up pro-rata if at least 3 items were completed, e.g. a score of 4 based on 3 completed items can be scaled up to a score of 7 (6.67 rounded up) for 5 items. A total difficulties score is generated by summing scores from all the scales except the prosocial scale. The resultant score ranges from 0 to 40, and is counted as missing of one of the 4 component scores is missing.
arm group label: mTranS-C
arm group type: Experimental
description: Access to a mobile and computer accessible adaptation of Transdiagnostic Sleep and Circadian Intervention
intervention type: Behavioral
intervention name: mTranS-C
description: mobile health
arm group label: mTranS-C
criteria: 
gender: All
minimum age: 12 Years
maximum age: 18 Years
healthy volunteers: No
last name: Lauren Asarnow, PhD
role: Principal Investigator
affiliation: University of California, San Francisco
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No