<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/NCT04452045</url>
  </required_header>
  <id_info>
    <org_study_id>UL1TR001872</org_study_id>
    <nct_id>NCT04452045</nct_id>
  </id_info>
  <brief_title>SweetDreams Sleep Study for Children With Autism</brief_title>
  <official_title>Feasibility of a Sleep Intervention for Children With Autism Spectrum Disorder Study</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>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This proposal will acquire preliminary data on the feasibility and effectiveness of an&#xD;
      innovative and scalable strategy for improving access to effective sleep health care for&#xD;
      preschool-aged children with Autism Spectrum Disorder (ASD). The investigators will develop&#xD;
      and test an on-line delivery adaptation of the existing behavioral sleep interventions for&#xD;
      preschool aged children.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Access to effective treatments for sleep disorders is a persistent challenge. This is due to&#xD;
      the lack of trained clinicians as well as caregiver resources to seek out and utilize such&#xD;
      critical services. The SweetDreams intervention will solve this problem with on-line delivery&#xD;
      of educational materials and treatment strategies for an evidence-based intervention. It will&#xD;
      be readily available to caregivers at any time and through multiple outlets such a computer,&#xD;
      tablet, and telephone, modes of delivery favored by and effective for parents of children in&#xD;
      this age group.&#xD;
&#xD;
      This adaptation will address key challenges to sleep health care for children with ASD: (1)&#xD;
      Learning differences of children with ASD by incorporating intervention principles from the&#xD;
      TEACHH model; (2) Overcome the challenge of treatment access due to the limited number of&#xD;
      qualified providers by developing didactic videos for online and mobile device delivery&#xD;
      (referred to as SweetDreams); and, (3) Responding to the NIH emphasis on developing &quot;more&#xD;
      effective interventions…by targeting interventions to the identified needs of community&#xD;
      members,&quot; SweetDreams will use a dynamic process involving extensive collaboration with&#xD;
      children, parents, developmental pediatricians, and other experts on youth with ASD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2020</start_date>
  <completion_date type="Actual">December 31, 2021</completion_date>
  <primary_completion_date type="Actual">December 30, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Children's Sleep Habits Questionnaire (CSHQ)</measure>
    <time_frame>baseline to end of treatment (anticipated average exposure 1 month)</time_frame>
    <description>Validated questionnaire; total score range between 33 and 99, with higher numbers representing more sleep problems</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Pittsburgh Sleep Quality Index (PSQI)</measure>
    <time_frame>baseline to end of treatment (anticipated average exposure 1 month)</time_frame>
    <description>Validated questionnaire; total score range between 0 and 21, with higher numbers representing worse sleep quality</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Autism Spectrum Disorder</condition>
  <condition>Insomnia</condition>
  <arm_group>
    <arm_group_label>SweetDreams</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Access to a mobile and computer accessible adaptation of existing evidence based sleep interventions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Waitlist Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Wait list condition with future access to a mobile and computer accessible adaptation of existing evidence based sleep interventions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SweetDreams</intervention_name>
    <description>SweetDreams is a mHealth adaptation of existing evidence-based sleep interventions. It is a user friendly and developmentally appropriate modularized 4-week web-based intervention available on computer, tablet or mobile phones.</description>
    <arm_group_label>SweetDreams</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  have poor sleep health&#xD;
&#xD;
          -  have a diagnosis of ASD&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  any regular sleep medication use (this does not include occasional over the counter&#xD;
             sleep aid)&#xD;
&#xD;
          -  known sleep apnea&#xD;
&#xD;
          -  unstable major medical conditions (e.g. severe asthma, diabetes).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Months</minimum_age>
    <maximum_age>60 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</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>University of California, San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>June 25, 2020</study_first_submitted>
  <study_first_submitted_qc>June 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <disposition_first_submitted>December 14, 2022</disposition_first_submitted>
  <disposition_first_submitted_qc>December 14, 2022</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">December 19, 2022</disposition_first_posted>
  <last_update_submitted>December 14, 2022</last_update_submitted>
  <last_update_submitted_qc>December 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>sleep</keyword>
  <keyword>autism</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>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>April 24, 2023</submitted>
    <returned>May 17, 2023</returned>
  </pending_results>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT04452045
org study id: UL1TR001872
nct id: NCT04452045
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
This proposal will acquire preliminary data on the feasibility and effectiveness of an
      innovative and scalable strategy for improving access to effective sleep health care for
      preschool-aged children with Autism Spectrum Disorder (ASD). The investigators will develop
      and test an on-line delivery adaptation of the existing behavioral sleep interventions for
      preschool aged children.
Access to effective treatments for sleep disorders is a persistent challenge. This is due to
      the lack of trained clinicians as well as caregiver resources to seek out and utilize such
      critical services. The SweetDreams intervention will solve this problem with on-line delivery
      of educational materials and treatment strategies for an evidence-based intervention. It will
      be readily available to caregivers at any time and through multiple outlets such a computer,
      tablet, and telephone, modes of delivery favored by and effective for parents of children in
      this age group.

      This adaptation will address key challenges to sleep health care for children with ASD: (1)
      Learning differences of children with ASD by incorporating intervention principles from the
      TEACHH model; (2) Overcome the challenge of treatment access due to the limited number of
      qualified providers by developing didactic videos for online and mobile device delivery
      (referred to as SweetDreams); and, (3) Responding to the NIH emphasis on developing "more
      effective interventions…by targeting interventions to the identified needs of community
      members," SweetDreams will use a dynamic process involving extensive collaboration with
      children, parents, developmental pediatricians, and other experts on youth with ASD.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in Children's Sleep Habits Questionnaire (CSHQ)
time frame: baseline to end of treatment (anticipated average exposure 1 month)
description: Validated questionnaire; total score range between 33 and 99, with higher numbers representing more sleep problems
measure: Change in Pittsburgh Sleep Quality Index (PSQI)
time frame: baseline to end of treatment (anticipated average exposure 1 month)
description: Validated questionnaire; total score range between 0 and 21, with higher numbers representing worse sleep quality
arm group label: SweetDreams
arm group type: Experimental
description: Access to a mobile and computer accessible adaptation of existing evidence based sleep interventions.
arm group label: Waitlist Control
arm group type: No Intervention
description: Wait list condition with future access to a mobile and computer accessible adaptation of existing evidence based sleep interventions.
intervention type: Device
intervention name: SweetDreams
description: SweetDreams is a mHealth adaptation of existing evidence-based sleep interventions. It is a user friendly and developmentally appropriate modularized 4-week web-based intervention available on computer, tablet or mobile phones.
arm group label: SweetDreams
criteria: 
gender: All
minimum age: 12 Months
maximum age: 60 Months
healthy volunteers: Accepts Healthy Volunteers
last name: Lauren Asarnow, PhD
role: Principal Investigator
affiliation: University of California, San Francisco
facility: 
country: United States
responsible party type: Sponsor
mesh term: Autistic Disorder
mesh term: Autism Spectrum Disorder
sharing ipd: No
submitted: April 24, 2023
returned: May 17, 2023