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/NCT06038591</url>
    </required_header>
    <id_info>
      <org_study_id>Pro00123879</org_study_id>
      <secondary_id>5P20GM130420</secondary_id>
      <nct_id>NCT06038591</nct_id>
    </id_info>
    <brief_title>Parent Intervention to Improve Child Sleep</brief_title>
    <official_title>Parenting Intervention to Improve Young Children's Sleep Among Families With Low Income</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of South Carolina</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Temple University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>National Institute of General Medical Sciences (NIGMS)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>University of South Carolina</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>
        In this study, the investigators pilot tested a parenting intervention to improve young&#xD;
        children's sleep in families with low income. Families were randomized to an intervention or&#xD;
        wait-list control group. The investigators hypothesized the intervention would be feasible&#xD;
        and acceptable to enrolled families.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This pilot study tested a parenting intervention to improve young children's sleep in&#xD;
        families with low income using a randomized controlled trial (RCT) design. Parents were&#xD;
        randomized to the intervention or wait-list control group. Intervention content was delivered&#xD;
        in virtual sessions with a parent and interventionist. The primary aim was to examine&#xD;
        intervention feasibility (e.g., recruitment, retention, acceptability) with a secondary goal&#xD;
        of preliminary efficacy on intervention changes in child sleep patterns to inform a future&#xD;
        large-scale RCT. Exploratory evidence was collected on changes in children's health behaviors&#xD;
        (e.g., diet, screen time), and social-emotional health (e.g., behavior problems) as&#xD;
        indicators for potential spillover effects on these domains.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 2, 2024</start_date>
    <completion_date type="Anticipated">December 19, 2025</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2025</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>Parallel Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Intervention feasibility: recruitment screening eligibility</measure>
      <time_frame>Through study completion, an average of 2 years</time_frame>
      <description>Percent of children screened who were eligible</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Intervention feasibility: recruitment screening enrollment</measure>
      <time_frame>Through study completion, an average of 2 years</time_frame>
      <description>Percent of children screened who were enrolled</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Intervention feasibility: recruitment duration</measure>
      <time_frame>Through study completion, an average of 2 years</time_frame>
      <description>Duration to reach the target sample</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Intervention feasibility: Enrollment yield for each recruitment strategy</measure>
      <time_frame>Through study completion, an average of 2 years</time_frame>
      <description>Percent of enrolled participants that were recruited via each recruitment strategy to determine the highest and lowest yielding strategies.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Intervention feasibility: retention attendance</measure>
      <time_frame>Through study completion, an average of 2 years</time_frame>
      <description>Percent attendance at assessment visits</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Intervention feasibility: retention percentage</measure>
      <time_frame>Through study completion, an average of 2 years</time_frame>
      <description>Percent of sample retained at post-intervention</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Intervention feasibility: retention dropout</measure>
      <time_frame>Through study completion, an average of 2 years</time_frame>
      <description>Percent of sample that drops out or is lost to follow-up</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Intervention feasibility: retention dropout reasons</measure>
      <time_frame>Through study completion, an average of 2 years</time_frame>
      <description>Reasons for dropping out of the study</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Intervention acceptability</measure>
      <time_frame>Through study completion, an average of 2 years</time_frame>
      <description>Acceptability will be assessed in an exit survey with Likert scale items and open-ended questions about intervention likes/dislikes and suggestions for future changes. Likert scale values range 1-5. Higher numbers indicate better outcomes (e.g., more positive acceptability)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Process measures: Intervention attendance</measure>
      <time_frame>Through study completion, an average of 2 years</time_frame>
      <description>Proportion of intervention sessions attended, including makeup sessions, obtained from attendance records.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Process measures: Dose</measure>
      <time_frame>Through study completion, an average of 2 years</time_frame>
      <description>Survey checklist completed by interventionists after each intervention session that rates the extent to which the program content was addressed</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Process measure: Implementation</measure>
      <time_frame>Through study completion, an average of 2 years</time_frame>
      <description>Survey checklist completed by interventionists after each intervention session that assess implementation barriers</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Process measure: Engagement</measure>
      <time_frame>Through study completion, an average of 2 years</time_frame>
      <description>Survey checklist completed by interventionists after each intervention session that assess perceived participant engagement</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Process measure: Content</measure>
      <time_frame>Through study completion, an average of 2 years</time_frame>
      <description>Survey checklist completed by interventionists after each intervention session that assess perceived appropriateness of session content</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Child sleep: night sleep duration</measure>
      <time_frame>Baseline (0 weeks) and post-intervention (8 weeks)</time_frame>
      <description>Wrist-worn actigraphy devices were used to calculate child's nighttime sleep duration</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Child sleep: daytime sleep duration</measure>
      <time_frame>Baseline (0 weeks) and post-intervention (8 weeks)</time_frame>
      <description>Wrist-worn actigraphy devices were used to calculate child's daytime sleep duration</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Child sleep: 24-hour sleep duration</measure>
      <time_frame>Baseline (0 weeks) and post-intervention (8 weeks)</time_frame>
      <description>Wrist-worn actigraphy devices were used to calculate child's 24-hour sleep duration</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Child sleep: sleep quality</measure>
      <time_frame>Baseline (0 weeks) and post-intervention (8 weeks)</time_frame>
      <description>Wrist-worn actigraphy devices were used to calculate child's sleep quality (e.g., wake after sleep onset)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Child sleep: sleep timing</measure>
      <time_frame>Baseline (0 weeks) and post-intervention (8 weeks)</time_frame>
      <description>Wrist-worn actigraphy devices were used to calculate variability in child's sleep timing</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Sleep</condition>
    <arm_group>
      <arm_group_label>Sleep Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The sleep intervention focuses on enhancing young children's sleep by providing parents with behavioral strategies and support. Interventionists will work with parents on establishing consistent soothing bedtime routines; behavioral regulation to manage bedtime resistance and nighttime wakings; goal setting, problem solving, and action planning; self-monitoring via daily sleep logs; and stimulus control of child's sleep environment.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Comparison/control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>The comparison arm is a no-contact control group. Parents and children will not receive any intervention. They will be placed on a wait-list, and then offered the sleep intervention once the post-assessments are complete.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Sleep Tight</intervention_name>
      <description>The sleep intervention focuses on enhancing young children's sleep by providing parents with behavioral strategies and support. Interventionists will work with parents on establishing consistent soothing bedtime routines; behavioral regulation to manage bedtime resistance and nighttime wakings; goal setting, problem solving, and action planning; self-monitoring via daily sleep logs; and stimulus control of child's sleep environment.</description>
      <arm_group_label>Sleep Intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Parents or primary caregivers 18 years of age or older&#xD;
  &#xD;
            -  Have a child 2-4 years of age&#xD;
  &#xD;
            -  Child's 24-hour sleep duration does not meet established recommendations based on&#xD;
               child age&#xD;
  &#xD;
            -  English speaking&#xD;
  &#xD;
            -  Annual household income &lt;= 200% of the Federal Poverty Line or receive assistance&#xD;
               benefits (e.g., SNAP, WIC)&#xD;
  &#xD;
            -  Computer or phone access for video calls&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Parent or child has a medical condition that impairs their ability to participate&#xD;
  &#xD;
            -  Child has a clinical sleep disorder&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>2 Years</minimum_age>
      <maximum_age>4 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Elizabeth Adams, PhD</last_name>
      <phone>803-777-0269</phone>
      <email>elizabeth-adams@sc.edu</email>
    </overall_contact>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 28, 2023</study_first_submitted>
    <study_first_submitted_qc>September 12, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of South Carolina</investigator_affiliation>
      <investigator_full_name>Elizabeth Adams</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <!-- 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/NCT06038591
  org study id: Pro00123879
  secondary id: 5P20GM130420
  nct id: NCT06038591
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  In this study, the investigators pilot tested a parenting intervention to improve young
        children's sleep in families with low income. Families were randomized to an intervention or
        wait-list control group. The investigators hypothesized the intervention would be feasible
        and acceptable to enrolled families.
  This pilot study tested a parenting intervention to improve young children's sleep in
        families with low income using a randomized controlled trial (RCT) design. Parents were
        randomized to the intervention or wait-list control group. Intervention content was delivered
        in virtual sessions with a parent and interventionist. The primary aim was to examine
        intervention feasibility (e.g., recruitment, retention, acceptability) with a secondary goal
        of preliminary efficacy on intervention changes in child sleep patterns to inform a future
        large-scale RCT. Exploratory evidence was collected on changes in children's health behaviors
        (e.g., diet, screen time), and social-emotional health (e.g., behavior problems) as
        indicators for potential spillover effects on these domains.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Single (Outcomes Assessor)
  measure: Intervention feasibility: recruitment screening eligibility
  time frame: Through study completion, an average of 2 years
  description: Percent of children screened who were eligible
  measure: Intervention feasibility: recruitment screening enrollment
  time frame: Through study completion, an average of 2 years
  description: Percent of children screened who were enrolled
  measure: Intervention feasibility: recruitment duration
  time frame: Through study completion, an average of 2 years
  description: Duration to reach the target sample
  measure: Intervention feasibility: Enrollment yield for each recruitment strategy
  time frame: Through study completion, an average of 2 years
  description: Percent of enrolled participants that were recruited via each recruitment strategy to determine the highest and lowest yielding strategies.
  measure: Intervention feasibility: retention attendance
  time frame: Through study completion, an average of 2 years
  description: Percent attendance at assessment visits
  measure: Intervention feasibility: retention percentage
  time frame: Through study completion, an average of 2 years
  description: Percent of sample retained at post-intervention
  measure: Intervention feasibility: retention dropout
  time frame: Through study completion, an average of 2 years
  description: Percent of sample that drops out or is lost to follow-up
  measure: Intervention feasibility: retention dropout reasons
  time frame: Through study completion, an average of 2 years
  description: Reasons for dropping out of the study
  measure: Intervention acceptability
  time frame: Through study completion, an average of 2 years
  description: Acceptability will be assessed in an exit survey with Likert scale items and open-ended questions about intervention likes/dislikes and suggestions for future changes. Likert scale values range 1-5. Higher numbers indicate better outcomes (e.g., more positive acceptability)
  measure: Process measures: Intervention attendance
  time frame: Through study completion, an average of 2 years
  description: Proportion of intervention sessions attended, including makeup sessions, obtained from attendance records.
  measure: Process measures: Dose
  time frame: Through study completion, an average of 2 years
  description: Survey checklist completed by interventionists after each intervention session that rates the extent to which the program content was addressed
  measure: Process measure: Implementation
  time frame: Through study completion, an average of 2 years
  description: Survey checklist completed by interventionists after each intervention session that assess implementation barriers
  measure: Process measure: Engagement
  time frame: Through study completion, an average of 2 years
  description: Survey checklist completed by interventionists after each intervention session that assess perceived participant engagement
  measure: Process measure: Content
  time frame: Through study completion, an average of 2 years
  description: Survey checklist completed by interventionists after each intervention session that assess perceived appropriateness of session content
  measure: Child sleep: night sleep duration
  time frame: Baseline (0 weeks) and post-intervention (8 weeks)
  description: Wrist-worn actigraphy devices were used to calculate child's nighttime sleep duration
  measure: Child sleep: daytime sleep duration
  time frame: Baseline (0 weeks) and post-intervention (8 weeks)
  description: Wrist-worn actigraphy devices were used to calculate child's daytime sleep duration
  measure: Child sleep: 24-hour sleep duration
  time frame: Baseline (0 weeks) and post-intervention (8 weeks)
  description: Wrist-worn actigraphy devices were used to calculate child's 24-hour sleep duration
  measure: Child sleep: sleep quality
  time frame: Baseline (0 weeks) and post-intervention (8 weeks)
  description: Wrist-worn actigraphy devices were used to calculate child's sleep quality (e.g., wake after sleep onset)
  measure: Child sleep: sleep timing
  time frame: Baseline (0 weeks) and post-intervention (8 weeks)
  description: Wrist-worn actigraphy devices were used to calculate variability in child's sleep timing
  arm group label: Sleep Intervention
  arm group type: Experimental
  description: The sleep intervention focuses on enhancing young children's sleep by providing parents with behavioral strategies and support. Interventionists will work with parents on establishing consistent soothing bedtime routines; behavioral regulation to manage bedtime resistance and nighttime wakings; goal setting, problem solving, and action planning; self-monitoring via daily sleep logs; and stimulus control of child's sleep environment.
  arm group label: Comparison/control
  arm group type: No Intervention
  description: The comparison arm is a no-contact control group. Parents and children will not receive any intervention. They will be placed on a wait-list, and then offered the sleep intervention once the post-assessments are complete.
  intervention type: Behavioral
  intervention name: Sleep Tight
  description: The sleep intervention focuses on enhancing young children's sleep by providing parents with behavioral strategies and support. Interventionists will work with parents on establishing consistent soothing bedtime routines; behavioral regulation to manage bedtime resistance and nighttime wakings; goal setting, problem solving, and action planning; self-monitoring via daily sleep logs; and stimulus control of child's sleep environment.
  arm group label: Sleep Intervention
  criteria: 
  gender: All
  minimum age: 2 Years
  maximum age: 4 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Elizabeth Adams, PhD
  phone: 803-777-0269
  email: elizabeth-adams@sc.edu
  responsible party type: Principal Investigator
  investigator affiliation: University of South Carolina
  investigator full name: Elizabeth Adams
  investigator title: Assistant Professor