<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/NCT04473222</url>
  </required_header>
  <id_info>
    <org_study_id>20-017788</org_study_id>
    <secondary_id>5K23HD094905-02</secondary_id>
    <nct_id>NCT04473222</nct_id>
  </id_info>
  <brief_title>Behavioral Sleep Intervention in Urban Primary Care: Aim 3</brief_title>
  <official_title>Implementing Evidence-based Behavioral Sleep Intervention in Urban Primary Care: Aim 3</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Hospital of Philadelphia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Children's Hospital of Philadelphia</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>
      Investigators will enroll up to 120 parent-child dyads from Children's Hospital of&#xD;
      Philadelphia (CHOP) urban primary care clinics. The primary objective of this randomized&#xD;
      clinical trial is to determine the whether the Sleep Well! behavioral sleep intervention is&#xD;
      feasible and acceptable to families. The investigators will also examine the direction and&#xD;
      magnitude in any change in child sleep and child behavior.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Behavioral sleep problems such as insomnia and insufficient sleep are common in toddlers and&#xD;
      preschoolers and disproportionately impact lower socioeconomic status (SES) children. Despite&#xD;
      a robust evidence base, behavioral sleep interventions are rarely tested with lower-SES&#xD;
      children or in primary care, an accessible service delivery setting. The primary objective of&#xD;
      this study is to determine whether the Sleep Well! behavioral sleep intervention is feasible&#xD;
      and acceptable to families. The investigators will also examine the direction and magnitude&#xD;
      of change in child sleep and behavior from pre-intervention to post-intervention. This is a&#xD;
      randomized controlled trial of the Sleep Well! program with pre-intervention,&#xD;
      post-intervention, and follow-up assessments. Caregiver-child dyads (child ages 1-5 years&#xD;
      with a sleep problem) will be recruited from CHOP urban primary care sites.&#xD;
&#xD;
      Sleep Well! is a brief, behavioral sleep intervention for toddlers and preschoolers who have&#xD;
      a caregiver-reported behavioral sleep problem or who are not getting enough sleep. The&#xD;
      intervention includes evidence-based behavioral sleep approaches and strategies to engage and&#xD;
      empower families. The primary outcomes for this open trial are feasibility (number of&#xD;
      caregivers recruited, engaged, and retained in intervention; participant intervention&#xD;
      attendance rate) and caregiver acceptability, assessed via a questionnaire and qualitative&#xD;
      post-intervention interview. Secondary outcomes are the direction and magnitude in any change&#xD;
      in child sleep. Tertiary outcomes are the direction and magnitude in change in child&#xD;
      behavior. Assessments occur at pre-intervention, post-intervention, and follow-up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 16, 2020</start_date>
  <completion_date type="Actual">July 31, 2023</completion_date>
  <primary_completion_date type="Actual">July 31, 2023</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>
    <intervention_model_description>Caregiver-child dyads (child ages 1-5 years with a sleep problem) will be recruited from CHOP urban primary care sites and randomly assigned either to the intervention or to an enhanced usual care condition (sleep education handout).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Research assistants conducting outcome assessments will be blinded to study condition.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Retention Rate</measure>
    <time_frame>24 months (study duration)</time_frame>
    <description>The study team will track the number of caregiver-child dyad participants who complete all study procedures following enrollment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Family Engagement and Adherence</measure>
    <time_frame>24 months (study duration)</time_frame>
    <description>Study interventionists will keep records of family intervention attendance, including the number of sessions that the family attended, rescheduled, and no-showed, and the number of phone calls that families completed. Study interventionists will also keep records of families' usage of intervention strategies, based on feedback from families in-session.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Treatment Acceptability</measure>
    <time_frame>3 months (post-intervention)</time_frame>
    <description>Caregivers will complete the Treatment Evaluation Inventory-Short Form, a widely used measures of treatment acceptability that has been adapted for the purposes of the Sleep Well! intervention, and the Multicultural Therapy Competency Inventory- Client Version to assess patient's perceptions of the Sleep Well! therapist's cultural sensitivity during discussions about safe sleep. Caregivers will also complete an audio-recorded, open-ended qualitative interview (15-20 minutes) with questions related to aspects of the intervention that were helpful/unhelpful, how the intervention could be improved, and the acceptability of the measurement process.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment Process</measure>
    <time_frame>24 months (study duration)</time_frame>
    <description>The study team will keep records of the number of planned assessments that are completed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Child Sleep Problems</measure>
    <time_frame>Baseline, post-intervention assessment, and 1 month follow-up</time_frame>
    <description>Caregivers will complete the BCSQ to report on the severity of any caregiver-perceived sleep problems at pre-intervention, post-intervention, and follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child Sleep Patterns</measure>
    <time_frame>Baseline, post-intervention assessment, and 1 month follow-up</time_frame>
    <description>Caregivers will complete the BCSQ to report on child sleep habits (sleep time, total sleep duration, night wakings, aspects of the sleep environment, etc.) at pre-intervention, post-intervention, and follow-up. The BCSQ is appropriate for children ages 1-5 years and has shown good reliability and moderate correspondence with actigraphic recordings of child-sleep.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child Sleep Patterns</measure>
    <time_frame>7 days at baseline, post-intervention assessment, and 1 month follow-up</time_frame>
    <description>Caregivers will have their child wear an actigraph to obtain objective estimates of sleep onset, sleep offset, and sleep duration at pre-intervention, post-intervention, and follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child Behavior Problems</measure>
    <time_frame>Baseline, post-intervention assessment, and 1 month follow-up</time_frame>
    <description>Caregivers will complete the Child Behavioral Checklist for ages 1.5-5 years to report on child internalizing and externalizing concerns at pre-intervention, post-intervention, and follow-up. The CBCL has shown strong reliability and validity in large validation studies and is a widely used measure of child behavior.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">104</enrollment>
  <condition>Sleep Disturbance</condition>
  <condition>Sleep Deprivation</condition>
  <condition>Sleep</condition>
  <arm_group>
    <arm_group_label>Sleep Well! Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this condition will begin the Sleep Well! intervention after initiating baseline, daily diary, and actigraph procedures. Sleep Well! will be provided over approximately 6-8 weeks and will include 3 sessions. Intervention sessions will typically last about an hour, but session length may vary.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Enhanced Usual Care</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The enhanced usual care condition will occur between 6 and 8 weeks. At randomization to this condition, participants will be provided with an evidence-based sleep guidelines for young children from the CHOP Parent Family Education manual. Participants in this condition will also be able to consult with their primary care physician for management of child sleep. Consistent with usual care in the CHOP system, the primary care physician may manage the sleep concern or choose to make a referral to the CHOP sleep center or to other behavioral health services internal or external to the CHOP system. Of note, the CHOP Parent Family Education handouts provide contact information for the CHOP Sleep Center and direct readers to follow-up with their primary care provider for further guidance.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Sleep Well!</intervention_name>
    <description>Sleep Well! is a brief, behavioral sleep intervention. The intervention was originally comprised of healthy sleep advice and tested in the context of a sleep health education campaign for impoverished children. Based on preliminary research regarding the need for sleep intervention in primary care, Investigators have expanded the intervention to more comprehensively address poor sleep health behaviors (e.g., use of electronics at bedtime; inconsistent and variable sleep schedules; lack of a bedtime routine) as well as insomnia (difficulty falling and staying asleep; the need for caregiver presence at bedtime) and insufficient sleep in toddlers and preschoolers who are living in disadvantaged contexts. Intervention components are based on effective pediatric behavioral sleep treatments.</description>
    <arm_group_label>Sleep Well! Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Sleep education</intervention_name>
    <description>Sleep education for caregivers of toddlers and preschoolers is provided via a Parent Family Education handout available to families and clinicians in the CHOP primary care network. The handout contains evidence-based advice about healthy sleep in early childhood.</description>
    <arm_group_label>Enhanced Usual Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Parental/guardian permission (informed consent)&#xD;
&#xD;
          2. Caregiver participant is the parent or legal guardian of the child subject&#xD;
&#xD;
          3. Caregiver/legal guardian is greater than or equal to 18 years of age.&#xD;
&#xD;
          4. Child between the ages of 1 and 5 years.&#xD;
&#xD;
          5. Presence of caregiver-reported child sleep problem determined by a Brief Child Sleep&#xD;
             Questionnaire item included in an eligibility screening questionnaire or child meets&#xD;
             American Academy of Sleep Medicine diagnostic criteria for either pediatric insomnia&#xD;
             or insufficient sleep, assessed through an eligibility screening questionnaire.&#xD;
&#xD;
          6. English-speaking.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Caregiver is not parent or legal guardian of child participant.&#xD;
&#xD;
          2. Presence of a child neurodevelopmental (e.g., autism spectrum disorder; Trisomy 21) or&#xD;
             chronic medical (e.g., sickle cell disease, cancer) concern in which the disorder or&#xD;
             treatment of the disorder impact sleep.&#xD;
&#xD;
          3. Caregivers/guardians or subjects who, in the opinion of the Investigator, may be&#xD;
             non-compliant with study schedules or procedures.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>5 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ariel Williamson, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's Hospital of Philadelphia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's Hospital of Philadelphia</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://babysleep.com</url>
    <description>Created by the Pediatric Sleep Council, babysleep.com provides comprehensive and expert-based information on baby and toddler sleep that is freely available to the public.</description>
  </link>
  <reference>
    <citation>Meltzer LJ, Mindell JA. Systematic review and meta-analysis of behavioral interventions for pediatric insomnia. J Pediatr Psychol. 2014 Sep;39(8):932-48. doi: 10.1093/jpepsy/jsu041. Epub 2014 Jun 19. Erratum In: J Pediatr Psychol. 2015 Mar;40(2):262-5.</citation>
    <PMID>24947271</PMID>
  </reference>
  <reference>
    <citation>Mindell JA, Williamson AA. Benefits of a bedtime routine in young children: Sleep, development, and beyond. Sleep Med Rev. 2018 Aug;40:93-108. doi: 10.1016/j.smrv.2017.10.007. Epub 2017 Nov 6.</citation>
    <PMID>29195725</PMID>
  </reference>
  <reference>
    <citation>Quach J, Gold L, Arnup S, Sia KL, Wake M, Hiscock H. Sleep well--be well study: improving school transition by improving child sleep: a translational randomised trial. BMJ Open. 2013 Oct 28;3(10):e004009. doi: 10.1136/bmjopen-2013-004009.</citation>
    <PMID>24165031</PMID>
  </reference>
  <reference>
    <citation>Allen SL, Howlett MD, Coulombe JA, Corkum PV. ABCs of SLEEPING: A review of the evidence behind pediatric sleep practice recommendations. Sleep Med Rev. 2016 Oct;29:1-14. doi: 10.1016/j.smrv.2015.08.006. Epub 2015 Sep 1.</citation>
    <PMID>26551999</PMID>
  </reference>
  <reference>
    <citation>Williamson AA, Milaniak I, Watson B, Cicalese O, Fiks AG, Power TJ, Barg FK, Beidas RS, Mindell JA, Rendle KA. Early Childhood Sleep Intervention in Urban Primary Care: Caregiver and Clinician Perspectives. J Pediatr Psychol. 2020 Sep 1;45(8):933-945. doi: 10.1093/jpepsy/jsaa024.</citation>
    <PMID>32430496</PMID>
  </reference>
  <reference>
    <citation>Mindell JA, Sedmak R, Boyle JT, Butler R, Williamson AA. Sleep Well!: A Pilot Study of an Education Campaign to Improve Sleep of Socioeconomically Disadvantaged Children. J Clin Sleep Med. 2016 Dec 15;12(12):1593-1599. doi: 10.5664/jcsm.6338.</citation>
    <PMID>27655459</PMID>
  </reference>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 2020</study_first_posted>
  <last_update_submitted>August 29, 2023</last_update_submitted>
  <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dyssomnias</mesh_term>
    <mesh_term>Parasomnias</mesh_term>
    <mesh_term>Sleep Deprivation</mesh_term>
  </condition_browse>
  <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/NCT04473222
org study id: 20-017788
secondary id: 5K23HD094905-02
nct id: NCT04473222
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Investigators will enroll up to 120 parent-child dyads from Children's Hospital of
      Philadelphia (CHOP) urban primary care clinics. The primary objective of this randomized
      clinical trial is to determine the whether the Sleep Well! behavioral sleep intervention is
      feasible and acceptable to families. The investigators will also examine the direction and
      magnitude in any change in child sleep and child behavior.
Behavioral sleep problems such as insomnia and insufficient sleep are common in toddlers and
      preschoolers and disproportionately impact lower socioeconomic status (SES) children. Despite
      a robust evidence base, behavioral sleep interventions are rarely tested with lower-SES
      children or in primary care, an accessible service delivery setting. The primary objective of
      this study is to determine whether the Sleep Well! behavioral sleep intervention is feasible
      and acceptable to families. The investigators will also examine the direction and magnitude
      of change in child sleep and behavior from pre-intervention to post-intervention. This is a
      randomized controlled trial of the Sleep Well! program with pre-intervention,
      post-intervention, and follow-up assessments. Caregiver-child dyads (child ages 1-5 years
      with a sleep problem) will be recruited from CHOP urban primary care sites.

      Sleep Well! is a brief, behavioral sleep intervention for toddlers and preschoolers who have
      a caregiver-reported behavioral sleep problem or who are not getting enough sleep. The
      intervention includes evidence-based behavioral sleep approaches and strategies to engage and
      empower families. The primary outcomes for this open trial are feasibility (number of
      caregivers recruited, engaged, and retained in intervention; participant intervention
      attendance rate) and caregiver acceptability, assessed via a questionnaire and qualitative
      post-intervention interview. Secondary outcomes are the direction and magnitude in any change
      in child sleep. Tertiary outcomes are the direction and magnitude in change in child
      behavior. Assessments occur at pre-intervention, post-intervention, and follow-up.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Caregiver-child dyads (child ages 1-5 years with a sleep problem) will be recruited from CHOP urban primary care sites and randomly assigned either to the intervention or to an enhanced usual care condition (sleep education handout).
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Research assistants conducting outcome assessments will be blinded to study condition.
measure: Retention Rate
time frame: 24 months (study duration)
description: The study team will track the number of caregiver-child dyad participants who complete all study procedures following enrollment.
measure: Family Engagement and Adherence
time frame: 24 months (study duration)
description: Study interventionists will keep records of family intervention attendance, including the number of sessions that the family attended, rescheduled, and no-showed, and the number of phone calls that families completed. Study interventionists will also keep records of families' usage of intervention strategies, based on feedback from families in-session.
measure: Treatment Acceptability
time frame: 3 months (post-intervention)
description: Caregivers will complete the Treatment Evaluation Inventory-Short Form, a widely used measures of treatment acceptability that has been adapted for the purposes of the Sleep Well! intervention, and the Multicultural Therapy Competency Inventory- Client Version to assess patient's perceptions of the Sleep Well! therapist's cultural sensitivity during discussions about safe sleep. Caregivers will also complete an audio-recorded, open-ended qualitative interview (15-20 minutes) with questions related to aspects of the intervention that were helpful/unhelpful, how the intervention could be improved, and the acceptability of the measurement process.
measure: Assessment Process
time frame: 24 months (study duration)
description: The study team will keep records of the number of planned assessments that are completed.
measure: Child Sleep Problems
time frame: Baseline, post-intervention assessment, and 1 month follow-up
description: Caregivers will complete the BCSQ to report on the severity of any caregiver-perceived sleep problems at pre-intervention, post-intervention, and follow-up.
measure: Child Sleep Patterns
time frame: Baseline, post-intervention assessment, and 1 month follow-up
description: Caregivers will complete the BCSQ to report on child sleep habits (sleep time, total sleep duration, night wakings, aspects of the sleep environment, etc.) at pre-intervention, post-intervention, and follow-up. The BCSQ is appropriate for children ages 1-5 years and has shown good reliability and moderate correspondence with actigraphic recordings of child-sleep.
measure: Child Sleep Patterns
time frame: 7 days at baseline, post-intervention assessment, and 1 month follow-up
description: Caregivers will have their child wear an actigraph to obtain objective estimates of sleep onset, sleep offset, and sleep duration at pre-intervention, post-intervention, and follow-up.
measure: Child Behavior Problems
time frame: Baseline, post-intervention assessment, and 1 month follow-up
description: Caregivers will complete the Child Behavioral Checklist for ages 1.5-5 years to report on child internalizing and externalizing concerns at pre-intervention, post-intervention, and follow-up. The CBCL has shown strong reliability and validity in large validation studies and is a widely used measure of child behavior.
arm group label: Sleep Well! Intervention
arm group type: Experimental
description: Participants in this condition will begin the Sleep Well! intervention after initiating baseline, daily diary, and actigraph procedures. Sleep Well! will be provided over approximately 6-8 weeks and will include 3 sessions. Intervention sessions will typically last about an hour, but session length may vary.
arm group label: Enhanced Usual Care
arm group type: Other
description: The enhanced usual care condition will occur between 6 and 8 weeks. At randomization to this condition, participants will be provided with an evidence-based sleep guidelines for young children from the CHOP Parent Family Education manual. Participants in this condition will also be able to consult with their primary care physician for management of child sleep. Consistent with usual care in the CHOP system, the primary care physician may manage the sleep concern or choose to make a referral to the CHOP sleep center or to other behavioral health services internal or external to the CHOP system. Of note, the CHOP Parent Family Education handouts provide contact information for the CHOP Sleep Center and direct readers to follow-up with their primary care provider for further guidance.
intervention type: Behavioral
intervention name: Sleep Well!
description: Sleep Well! is a brief, behavioral sleep intervention. The intervention was originally comprised of healthy sleep advice and tested in the context of a sleep health education campaign for impoverished children. Based on preliminary research regarding the need for sleep intervention in primary care, Investigators have expanded the intervention to more comprehensively address poor sleep health behaviors (e.g., use of electronics at bedtime; inconsistent and variable sleep schedules; lack of a bedtime routine) as well as insomnia (difficulty falling and staying asleep; the need for caregiver presence at bedtime) and insufficient sleep in toddlers and preschoolers who are living in disadvantaged contexts. Intervention components are based on effective pediatric behavioral sleep treatments.
arm group label: Sleep Well! Intervention
intervention type: Behavioral
intervention name: Sleep education
description: Sleep education for caregivers of toddlers and preschoolers is provided via a Parent Family Education handout available to families and clinicians in the CHOP primary care network. The handout contains evidence-based advice about healthy sleep in early childhood.
arm group label: Enhanced Usual Care
criteria: 
gender: All
minimum age: 1 Year
maximum age: 5 Years
healthy volunteers: No
last name: Ariel Williamson, PhD
role: Principal Investigator
affiliation: Children's Hospital of Philadelphia
facility: 
country: United States
url: http://babysleep.com
description: Created by the Pediatric Sleep Council, babysleep.com provides comprehensive and expert-based information on baby and toddler sleep that is freely available to the public.
citation: Meltzer LJ, Mindell JA. Systematic review and meta-analysis of behavioral interventions for pediatric insomnia. J Pediatr Psychol. 2014 Sep;39(8):932-48. doi: 10.1093/jpepsy/jsu041. Epub 2014 Jun 19. Erratum In: J Pediatr Psychol. 2015 Mar;40(2):262-5.
PMID: 24947271
citation: Mindell JA, Williamson AA. Benefits of a bedtime routine in young children: Sleep, development, and beyond. Sleep Med Rev. 2018 Aug;40:93-108. doi: 10.1016/j.smrv.2017.10.007. Epub 2017 Nov 6.
PMID: 29195725
citation: Quach J, Gold L, Arnup S, Sia KL, Wake M, Hiscock H. Sleep well--be well study: improving school transition by improving child sleep: a translational randomised trial. BMJ Open. 2013 Oct 28;3(10):e004009. doi: 10.1136/bmjopen-2013-004009.
PMID: 24165031
citation: Allen SL, Howlett MD, Coulombe JA, Corkum PV. ABCs of SLEEPING: A review of the evidence behind pediatric sleep practice recommendations. Sleep Med Rev. 2016 Oct;29:1-14. doi: 10.1016/j.smrv.2015.08.006. Epub 2015 Sep 1.
PMID: 26551999
citation: Williamson AA, Milaniak I, Watson B, Cicalese O, Fiks AG, Power TJ, Barg FK, Beidas RS, Mindell JA, Rendle KA. Early Childhood Sleep Intervention in Urban Primary Care: Caregiver and Clinician Perspectives. J Pediatr Psychol. 2020 Sep 1;45(8):933-945. doi: 10.1093/jpepsy/jsaa024.
PMID: 32430496
citation: Mindell JA, Sedmak R, Boyle JT, Butler R, Williamson AA. Sleep Well!: A Pilot Study of an Education Campaign to Improve Sleep of Socioeconomically Disadvantaged Children. J Clin Sleep Med. 2016 Dec 15;12(12):1593-1599. doi: 10.5664/jcsm.6338.
PMID: 27655459
responsible party type: Sponsor
mesh term: Dyssomnias
mesh term: Parasomnias
mesh term: Sleep Deprivation
sharing ipd: No