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Sleep Health Literacy in Head Start (SLEEP)

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ClinicalTrials.gov Identifier: NCT03556462
Recruitment Status : Active, not recruiting
First Posted : June 14, 2018
Last Update Posted : August 6, 2021
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Karen Bonuck, Albert Einstein College of Medicine

Tracking Information
First Submitted Date  ICMJE May 18, 2018
First Posted Date  ICMJE June 14, 2018
Last Update Posted Date August 6, 2021
Actual Study Start Date  ICMJE May 21, 2018
Actual Primary Completion Date October 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 13, 2018)
Child Sleep Duration: Intervention vs. Control (Total) [ Time Frame: 9 months ]
The primary outcome is differences between Intervention vs. Control periods (per stepped wedge design) weeknight sleep: Sunday-Thursday bedtimes and Monday-Friday wake-times. Agency staff will distribute and collect sleep logs from parent participants at 5 points: 1 week pre/post the 2 "cross-overs" and at final follow-up. Analyses will be based upon weeknight (Sun-Thurs) sleep duration from sleep logs, assessed in minutes. Hypothesis: longer sleep duration for Intervention vs. Control periods
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 13, 2018)
  • Child Sleep Duration: >30 Minutes [ Time Frame: 9 months ]
    Hypothesis: Intervention group will sleep >= 30 minutes longer than Controls difference in duration between Intervention vs. Control periods
  • Child sleep difficulties [ Time Frame: 12 months ]
    Tayside Children's Sleep Questionnaire- This simple 10-item tool detects 'settling' difficulties (e.g., getting to/staying asleep) in 1-5 year olds. Nine items, scored on a 5-point scale, refer to the past 3 months: a score of > 8/36 indicates a mild/moderate settling difficulty. The last (yes/no) item asks if the child has a sleep problem. hypothesize: a) lower mean Tayside scores for Intervention vs. Control periods, b) a lesser likelihood of Intervention vs. Control scores above the criterion indicative of mild/moderate difficulties (> 8/36) and c) lower rates of parents reporting a sleep problem (Yes/No) in Intervention vs. Control periods.
  • Parent KASB (Knowledge/Attitudes/Self-Efficacy/Beliefs) [ Time Frame: 12 months ]
    Parents rate agreement with items on a 5-point scale. Knowledge items (n=12); Attitude items (n=5); Self-efficacy items (n=7) and Belief items (n=2) query the value of a regular bedtime and bedtime routine. There is one multiple-choice item about how much sleep a preschooler needs. Hypotheses: a) higher KASB total scores for Intervention vs. Control phases, and b) higher scores for each of the Knowledge, Attitudes, Self-Efficacy, and Behavior domains for Intervention vs. Control phases. As descriptive data, repeat analyses will be conducted for pre/post the ECSEP within each agency.
  • Child Sleep Duration: 1 Year Follow-Up [ Time Frame: 12 months ]
    Hypothesis: Intervention group will sleep >= 15 minutes longer than Controls at 1 Year Follow-Up
  • Classroom Climate [ Time Frame: 9 months ]
    Investigators will collect a measure of classroom climate, reflecting teacher-child interactions: ● Classroom Climate- the Classroom Assessment Scoring System (CLASSTM) is an evidence-based tool developed by the NIH. Data are collected quarterly by certified observers. We will analyze CLASS data for: Positive Climate, Negative Climate, and Behavior Management. Scores range from 1-7: Low (1-2), Medium (3-4) and High (5-7). It is hypothesized that CLASS scores (or their equivalent) for Positive Climate, Negative Climate, and Behavior Management will differ significantly for Intervention vs. Control periods at the classroom, site, and agency levels.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sleep Health Literacy in Head Start
Official Title  ICMJE Increasing Sleep Health Literacy: A Social Ecological Approach
Brief Summary Conduct Sleep Health Literacy RCT- Using a stepped wedge randomized design, investigators will enroll 540 parent-child dyads from 7 Head Start agencies in New York. Agencies cross-over from control to intervention. Outcomes are a) child sleep duration, b) parent knowledge, attitudes, self-efficacy and behavior, c) child sleep difficulty and d) classroom climate. Invesetigators will compare intervention vs. control data across agencies and pre/post data within agency, with parental health literacy as a moderator. Investigators will collect process and fidelity data.
Detailed Description Abstract: Inadequate and/or poor quality sleep in early childhood impairs social-emotional and cognitive function (via effects on the developing brain), and markedly increases obesity risk (via hormonal and endocrine effects). Short sleep duration, behavioral sleep problems and sleep-disordered breathing peak at 20%-50%, during the preschool years (ages 3-5). Healthy sleep habits increase sleep duration and prevent behavioral sleep problems. Awareness of sleep-disordered breathing symptoms leads to timely treatment for it. Despite ample data on sleep problems "…much less work has been done on effective strategies to promote sleep as a healthy behavior (CDC 2013)". This study's overarching goal is to empower families of preschool children with the knowledge and skills needed for healthy sleep, and to recognize a sleep problem. It builds on work in Head Start, an early childhood education (ECE) program for disadvantaged preschool children and their families: The team's Early Childhood Sleep Education Program (ECSEP™) educates Head Start teachers, children, and parents about healthy sleep in a way they can process and understand. In a randomized controlled trial, the children in the ECSEP group slept 30 minutes longer/night. As well, our UCLA Health Care Institute's structured approach to low literacy health training in Head Start (to reduce ER visits, obesity, etc.) has reached >100,000 families. The proposed study will implement a Social-Ecological web of multi-level interventions to reinforce the ECSEP, and to promote healthy sleep throughout ECE. Within Head Start, the team will create new delivery platforms (print & video, family visits) that 'amplify' the ECSEP. Beyond Head Start, the team will educate communities, and partner with stakeholders on strategies designed to embed 'sleep health literacy' in ECE policy. This project will: 1) Adapt sleep education material into additional multi-media formats, and; apply the Health Care Institute model to train Head Start staff to mount interventions and collect data. 2) Enroll 540 parent-child dyads from 7 Head Start agencies in New York in a stepped wedge randomized controlled trial. Investigators will analyze trial effects on primary outcomes: a) child sleep duration, b) parent knowledge, attitudes, self-efficacy and behavior, and c) child sleep difficulties. 3) Assess the feasibility of screening and guidance for sleep problems (vs. sleep health) for a future efficacy study. Secondary outcomes are: classroom behaviors, policy change, and process data. Poor sleep in early development has ramifications for years to come, perhaps through adulthood. Head Start serves low-income, mainly racial-ethnic minority families, in whom sleep health disparities are greatest-- but are modifiable. This study joins together proven methods of delivering health literacy (Health Care Institute) and sleep health (ECSEP) programs in Head Start. Intervening at every level of the Social-Ecological model maximizes the study's reach and sustainability. Integrating sleep health literacy into ECE nationwide could ultimately benefit upwards of 4 million children. The potential impact upon human health is far-reaching.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
Stepped wedge cluster RCT Participating agencies (n=7) were randomly assigned to 'wedge 1' or 'wedge 2': Wedge 1 agencies will begin the intervention in Fall 2018 and Wedge 2 agencies will begin the intervention in Spring 2019.
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Sleep
Intervention  ICMJE Other: Sleep Health Education
Parents and children receive sleep health education
Study Arms  ICMJE
  • Experimental: Sleep Health Interventions

    Sleep Health Interventions:

    Parents- a) invited to 1 hour workshop about healthy sleep, b) invited to attend a brief (app. 20 minute) Sleep Health Flipchart education either 1-on-1 or in a small group.

    Children: exposed to 2 week 40min/day healthy sleep curriculum in the classroom.Agency: Video and print material

    Intervention: Other: Sleep Health Education
  • No Intervention: Control Period
    No Intervention, but data collection
Publications * Bonuck K, Collins-Anderson A, Ashkinaze J, Karasz A, Schwartz A. Environmental Scan of Sleep Health in Early Childhood Programs. Behav Sleep Med. 2020 Sep-Oct;18(5):598-610. doi: 10.1080/15402002.2019.1640222. Epub 2019 Jul 18.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 4, 2019)
538
Original Estimated Enrollment  ICMJE
 (submitted: June 13, 2018)
540
Estimated Study Completion Date  ICMJE February 3, 2022
Actual Primary Completion Date October 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Attends 3-year old Head Start class at site for 2018-2019 school year
  2. English or Spanish
  3. Family affirms that plans are for child to remain at site for duration of school year (per screener item)
  4. Respondent affirms that they are regularly involved in the child's bedtime routine (per screener item)

Exclusion Criteria:

  • Child not age-eligible (see above)
  • Family not language eligible (see above)
  • Family not planning to remain for duration of 2018-19 school year
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 3 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03556462
Other Study ID Numbers  ICMJE 2014-3031
R01HD082129 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Karen Bonuck, Albert Einstein College of Medicine
Study Sponsor  ICMJE Albert Einstein College of Medicine
Collaborators  ICMJE
  • National Institutes of Health (NIH)
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators  ICMJE
Principal Investigator: Karen Bonuck, PhD Albert Einstein College of Medicine
PRS Account Albert Einstein College of Medicine
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP