Community Partnership for Healthy Sleep: Sleep Well, Bee Well Part 2
NCT ID: NCT05130229
Last Updated: 2023-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
98 participants
INTERVENTIONAL
2022-03-08
2022-10-31
Brief Summary
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Detailed Description
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A total of 44 families of 1-2.5 year-old healthy children and EHS teachers from both childcare centers will be enrolled. The program teaches early childhood educators about healthy sleep for young children and will train them to be confident facilitators of educational conversations about sleep with parents.
The following specific aims will be addressed with this study: (1) Determine the feasibility of SWBW among 44 families of 1-2.5-year-old healthy children and EHS teachers from both childcare centers; (1a) refine and standardize the SWBW intervention materials (videos, handouts, activities); (1b) determine the feasibility (acceptability, demand, implementation, practicality, adaptation, integration, expansion, and limited-efficacy testing) of the SWBW intervention, study design and recruitment goals; (2) Evaluate the preliminary efficacy of SWBW in 22 intervention and 22 wait-list control parent-child dyads on (2a) toddlers' sleep health (duration, timing, continuity), bedtime routines and parent and EHS teacher sleep knowledge and (2b) toddler's social-emotional health, bedtime routines, parent well-being and parent-teacher engagement. The results from this pilot study will provide support for a future larger-scale cluster-randomized trial that will be fully powered to test the effects of the SWBW program in multiple EHS programs enrolled in the New England Head Start Association.
Parent questionnaires and sleep characteristics of children (actigraphy and parent report) will be collected at three timepoints- Time 1, 2, and 3. Time 1 is the first Baseline Data Collection for the Waitlist Control Group and Intervention Group, and these data will be collected prior to either group starting the 3-week SWBW intervention. Between Time 1 and Time 2, the Intervention Group will receive the 3-week SWBW intervention at the childcare center. Time 2 data collection for both groups will occur during the week following the completion of the intervention received by the Intervention Group. Time 2 data will serve as post-intervention data for the Intervention Group. Time 2 data will also be compared to the first baseline data collected during Time 1 to account for the Waitlist Control Group's waiting time and be used as secondary baseline pre-intervention data for the Waitlist Control Group. Lastly, Time 3 is the Post-Intervention Data Collection for the Waitlist Control Group and will be examined to assess the sustainability of the intervention in the Intervention Group.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Sleep Well Bee Well
Sleep program to help toddlers sleep better
Sleep Well Bee Well
Sleep program to help toddlers sleep better
Wait-list Control
The wait-listed group will begin the intervention after the intervention group
Sleep Well Bee Well
Sleep program to help toddlers sleep better
Interventions
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Sleep Well Bee Well
Sleep program to help toddlers sleep better
Eligibility Criteria
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Inclusion Criteria
* Fluent in English/Spanish
* Parents of 12-36 month old children
\- Attending either LuLac or West Haven Child Development Center program
Exclusion Criteria
* Travel across 2 or more time zones in the 2 weeks prior to enrollment
* Engaged in concurrent behavioral management for sleep concerns by either primary care providers or sleep specialist.
* Other diagnosed health problem known to be associated with sleep problems (e.g. cerebral palsy, genetic disease, Down's syndrome).
* Must be over 18 years old
* Speak English or Spanish
18 Years
ALL
Yes
Sponsors
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National Institute of Nursing Research (NINR)
NIH
Yale University
OTHER
Responsible Party
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Principal Investigators
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Monica Ordway, PhD
Role: PRINCIPAL_INVESTIGATOR
Associate Professor of Nursing
Locations
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Lulac Head Start, Inc.
New Haven, Connecticut, United States
West Haven Child Development Center
West Haven, Connecticut, United States
Countries
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Other Identifiers
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2000026375
Identifier Type: -
Identifier Source: org_study_id