Sleep Health Literacy in Head Start

NCT ID: NCT03556462

Last Updated: 2022-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 538 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-21
• Study Completion Date: 2022-02-03

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.

Conditions

Sleep

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Sleep Health Education

Intervention Type: OTHER

Parents and children receive sleep health education

Control Period

No Intervention, but data collection

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Sleep Health Education

Parents and children receive sleep health education

Intervention Type: OTHER

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 3 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Albert Einstein College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Karen Bonuck

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karen Bonuck, PhD

Role: PRINCIPAL_INVESTIGATOR

Albert Einstein College of Medicine

Locations

Yeled v"Yalda Early Childhood Center, Inc.

Brooklyn, New York, United States

Committee for Early Childhood Development D.D.C. incl

Hollis, New York, United States

East Harlem Council for Human Services, Inc.

Manhattan, New York, United States

Cattaraugus and Wyoming Counties Project Head Start

Olean, New York, United States

Agri-Business Child Development

Schenectady, New York, United States

Kingsbridge Heights Community Center

The Bronx, New York, United States

Family Services of Westchester

White Plains, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 35881396 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31318273 (View on PubMed)

Other Identifiers

R01HD082129

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2014-3031

Identifier Type: -

Identifier Source: org_study_id