<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/NCT01729715</url>
  </required_header>
  <id_info>
    <org_study_id>IRB12-00439</org_study_id>
    <nct_id>NCT01729715</nct_id>
  </id_info>
  <brief_title>Helping Young Children Sleep</brief_title>
  <official_title>Helping Young Children Sleep</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nationwide Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nationwide Children's Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators are conducting a randomized trial of behavioral treatments for young&#xD;
      children with insomnia. The investigators are comparing the improvement in sleep patterns&#xD;
      after families are given access to Internet sleep instructions compared to DVD sleep&#xD;
      instructions.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">March 2017</completion_date>
  <primary_completion_date type="Actual">November 2015</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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Brief infant sleep questionnaire</measure>
    <time_frame>3 weeks</time_frame>
    <description>infant sleep patterns and sleep problems</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Profile of mood states</measure>
    <time_frame>1 week</time_frame>
    <description>parental mood in the past week</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pittsburgh sleep quality index</measure>
    <time_frame>1 month</time_frame>
    <description>parental sleep patterns within the past month</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">240</enrollment>
  <condition>Insomnia</condition>
  <arm_group>
    <arm_group_label>Internet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Internet site that offers parents tips on promoting sleep in infants and toddlers</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DVD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>DVD that offers parents tips on promoting sleep in infants and toddlers</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No treatment</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Internet</intervention_name>
    <arm_group_label>Internet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>DVD</intervention_name>
    <arm_group_label>DVD</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  6-36 months&#xD;
&#xD;
          -  difficulties falling asleep or staying asleep&#xD;
&#xD;
          -  DVD and internet access&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Under 14 pounds&#xD;
&#xD;
          -  Requires nighttime feeding or parental intervention for health reasons&#xD;
&#xD;
          -  Chronic medical or psychological conditions such as asthma or autism&#xD;
&#xD;
          -  Parents prefer co-sleeping&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>36 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mark Splaingard, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nationwide Children's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nationwide Children's Hospital</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>November 15, 2012</study_first_submitted>
  <study_first_submitted_qc>November 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 20, 2012</study_first_posted>
  <last_update_submitted>July 19, 2017</last_update_submitted>
  <last_update_submitted_qc>July 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Nationwide Children's Hospital</investigator_affiliation>
    <investigator_full_name>Mark Splaingard</investigator_full_name>
    <investigator_title>Prof. and Dir. of pediatric sleep medicine</investigator_title>
  </responsible_party>
  <keyword>Pediatric</keyword>
  <keyword>Insomnia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Initiation and Maintenance Disorders</mesh_term>
  </condition_browse>
  <!-- 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/NCT01729715
org study id: IRB12-00439
nct id: NCT01729715
lead sponsor: 
has dmc: No
The investigators are conducting a randomized trial of behavioral treatments for young
      children with insomnia. The investigators are comparing the improvement in sleep patterns
      after families are given access to Internet sleep instructions compared to DVD sleep
      instructions.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Brief infant sleep questionnaire
time frame: 3 weeks
description: infant sleep patterns and sleep problems
measure: Profile of mood states
time frame: 1 week
description: parental mood in the past week
measure: Pittsburgh sleep quality index
time frame: 1 month
description: parental sleep patterns within the past month
arm group label: Internet
arm group type: Experimental
description: Internet site that offers parents tips on promoting sleep in infants and toddlers
arm group label: DVD
arm group type: Experimental
description: DVD that offers parents tips on promoting sleep in infants and toddlers
arm group label: No treatment
arm group type: No Intervention
intervention type: Behavioral
intervention name: Internet
arm group label: Internet
intervention type: Behavioral
intervention name: DVD
arm group label: DVD
criteria: 
gender: All
minimum age: 6 Months
maximum age: 36 Months
healthy volunteers: Accepts Healthy Volunteers
last name: Mark Splaingard, MD
role: Principal Investigator
affiliation: Nationwide Children's Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Nationwide Children's Hospital
investigator full name: Mark Splaingard
investigator title: Prof. and Dir. of pediatric sleep medicine
mesh term: Sleep Initiation and Maintenance Disorders