Clinical trial NCT05130229: Community Partnership for Healthy Sleep: Sleep Well, Bee Well Part 2
Official title: Community Partnership for Healthy Sleep: Sleep Well, Bee Well Part 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Sleep
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2021-11-23
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Using a pragmatic cluster randomized trial, this study aims to examine the feasibility, and acceptability of a 3-week behavioral sleep intervention, Sleep Well, Bee Well (SWBW), and to test the preliminary efficacy of SWBW compared to a wait-list control with children ages 1-2.5 years old at two Early Head Start (EHS) centers on toddler sleep characteristics and parent wellbeing.

Detailed description: The first phase of this study is under another study (please see NCT03045874). For this study (Phase II), a pilot pragmatic cluster randomized trial to test the feasibility and preliminary efficacy of SWBW in improving sleep health in children ages 1-2.5 years attending two Early Head Start (EHS) programs will be studied.

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.

Eligibility criteria: Inclusion Criteria for parent:

* Primary caregiver of toddler (e.g. mom, dad, aunt, grandparent)
* Fluent in English/Spanish
* Parents of 12-36 month old children

Inclusion Criteria for Toddler:

- Attending either LuLac or West Haven Child Development Center program

Exclusion Criteria for Toddler:

* Diagnosed with sleep apnea
* 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).

Inclusion / Exclusion Criteria for EHS Teacher:

* Must be over 18 years old
* Speak English or Spanish

Primary outcomes:
measure: Change in Children's bedtime
timeFrame: 21 days
measure: Change in Bedtime Variability
timeFrame: 21 days
measure: Change in Children's sleep duration
timeFrame: 21 days
measure: Change in Children's Sleep Duration Variability
timeFrame: 21 days
measure: Change in Bedtime Routine
timeFrame: 21 days
measure: Change in Bedtime Routine
timeFrame: 12 days
measure: Change in Children's Bedtime Routine
timeFrame: 21 days
measure: Change in Parent reported sleep characteristics
timeFrame: 21 days
Secondary outcomes:
measure: Change in Toddler social-emotional health
timeFrame: 21 days
measure: Change in Parenting stress
timeFrame: 21 days
measure: Change in Depressive symptoms among parents
timeFrame: 21 days
measure: Change in Self-report of parental self-efficacy
timeFrame: 21 days
measure: Change in Parental knowledge and beliefs about children's sleep
timeFrame: 21 days
Other outcomes:
measure: Intervention feasibility and acceptability
timeFrame: 21 days
measure: Children's nap timing
timeFrame: 21 days
measure: Change in Self-report of parents' sleep disturbance
timeFrame: 21 days
measure: Change in Self-report of parents' hopefulness
timeFrame: 21 days
measure: Sleep Diary
timeFrame: 21 days
measure: Change in Parental Physical and Mental Health
timeFrame: 21 days
measure: Change in Parent-Teacher Involvement
timeFrame: 21 days
Locations:
city: New Haven
country: United States
facility: Lulac Head Start, Inc.
state: Connecticut
city: West Haven
country: United States
facility: West Haven Child Development Center
state: Connecticut
Study officials:
affiliation: Associate Professor of Nursing
name: Monica Ordway, PhD
role: PRINCIPAL_INVESTIGATOR
References: