Clinical trial NCT03556462: Sleep Health Literacy in Head Start
Official title: Increasing Sleep Health Literacy: A Social Ecological Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2018-06-14
Enrollment: 538
Sex: ALL
Minimum age (years): 3
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Child Sleep Duration: Intervention vs. Control (Total)
timeFrame: 9 months
Secondary outcomes:
measure: Child Sleep Duration: >30 Minutes
timeFrame: 9 months
measure: Child sleep difficulties
timeFrame: 12 months
measure: Parent KASB (Knowledge/Attitudes/Self-Efficacy/Beliefs)
timeFrame: 12 months
measure: Child Sleep Duration: 1 Year Follow-Up
timeFrame: 12 months
measure: Classroom Climate
timeFrame: 9 months
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Kingsbridge Heights Community Center
state: New York
city: Brooklyn
country: United States
facility: Yeled v"Yalda Early Childhood Center, Inc.
state: New York
city: Hollis
country: United States
facility: Committee for Early Childhood Development D.D.C. incl
state: New York
city: Manhattan
country: United States
facility: East Harlem Council for Human Services, Inc.
state: New York
city: Olean
country: United States
facility: Cattaraugus and Wyoming Counties Project Head Start
state: New York
city: Schenectady
country: United States
facility: Agri-Business Child Development
state: New York
city: White Plains
country: United States
facility: Family Services of Westchester
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine
name: Karen Bonuck, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bonuck K, Collins-Anderson A, Schechter CB, Felt BT, Chervin RD. Effects of a Sleep Health Education Program for Children and Parents on Child Sleep Duration and Difficulties: A Stepped-Wedge Cluster Randomized Clinical Trial. JAMA Netw Open. 2022 Jul 1;5(7):e2223692. doi: 10.1001/jamanetworkopen.2022.23692.
citation: 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.