Sleep Health Literacy in Head Start

Sleep Clinical Trial

— SLEEP  

Official title:

Increasing Sleep Health Literacy: A Social Ecological Approach

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03556462
• Other study ID #: 2014-3031
• Secondary ID: R01HD082129
• Status: Completed
• Phase: N/A
• Start date: May 21, 2018
• Est. completion date: February 3, 2022

Study information

• Verified date: March 2022
• Source: Albert Einstein College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 538
• Est. completion date: February 3, 2022
• Est. primary completion date: October 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 3 Years

Eligibility

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

Related Conditions & MeSH terms

• Sleep

Intervention

Other:
• Sleep Health Education
Parents and children receive sleep health education

Locations

Country	Name	City	State
United States	Kingsbridge Heights Community Center	Bronx	New York
United States	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	Family Services of Westchester	White Plains	New York

Sponsors (3)

Lead Sponsor	Collaborator
Albert Einstein College of Medicine	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Child Sleep Duration: Intervention vs. Control (Total)	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	9 months
Secondary	Child Sleep Duration: >30 Minutes	Hypothesis: Intervention group will sleep >= 30 minutes longer than Controls difference in duration between Intervention vs. Control periods	9 months
Secondary	Child sleep difficulties	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.	12 months
Secondary	Parent KASB (Knowledge/Attitudes/Self-Efficacy/Beliefs)	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.	12 months
Secondary	Child Sleep Duration: 1 Year Follow-Up	Hypothesis: Intervention group will sleep >= 15 minutes longer than Controls at 1 Year Follow-Up	12 months
Secondary	Classroom Climate	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.	9 months