NCT03556462

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
538

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2018

Completed
3 days until next milestone

Study Start

First participant enrolled

May 21, 2018

Completed
24 days until next milestone

First Posted

Study publicly available on registry

June 14, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2019

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 3, 2022

Completed
Last Updated

March 17, 2022

Status Verified

March 1, 2022

Enrollment Period

1.4 years

First QC Date

May 18, 2018

Last Update Submit

March 16, 2022

Conditions

Sleep

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Child Sleep Duration: >30 Minutes

    9 months

  • Child sleep difficulties

    12 months

  • Parent KASB (Knowledge/Attitudes/Self-Efficacy/Beliefs)

    12 months

  • Child Sleep Duration: 1 Year Follow-Up

    12 months

  • Classroom Climate

    9 months

Study Arms (2)

Sleep Health Interventions

EXPERIMENTAL

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

Other: Sleep Health Education

Control Period

NO INTERVENTION

No Intervention, but data collection

Interventions

Sleep Health EducationOTHER

Parents and children receive sleep health education

Sleep Health Interventions

Eligibility Criteria

Age3 Years - 3 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Attends 3-year old Head Start class at site for 2018-2019 school year
  • English or Spanish
  • Family affirms that plans are for child to remain at site for duration of school year (per screener item)
  • Respondent affirms that they are regularly involved in the child's bedtime routine (per screener item)

You may not qualify if:

  • Child not age-eligible (see above)
  • Family not language eligible (see above)
  • Family not planning to remain for duration of 2018-19 school year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Yeled v"Yalda Early Childhood Center, Inc.

Brooklyn, New York, 11218, United States

Location

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

Hollis, New York, 11423, United States

Location

East Harlem Council for Human Services, Inc.

Manhattan, New York, 10035, United States

Location

Cattaraugus and Wyoming Counties Project Head Start

Olean, New York, 14760, United States

Location

Agri-Business Child Development

Schenectady, New York, 12308, United States

Location

Kingsbridge Heights Community Center

The Bronx, New York, 10463, United States

Location

Family Services of Westchester

White Plains, New York, 10603, United States

Location

Related Publications (2)

  • 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.

    PMID: 35881396DERIVED

  • 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.

    PMID: 31318273DERIVED

Study Officials

  • Karen Bonuck, PhD

    Albert Einstein College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 18, 2018

First Posted

June 14, 2018

Study Start

May 21, 2018

Primary Completion

October 30, 2019

Study Completion

February 3, 2022

Last Updated

March 17, 2022

Record last verified: 2022-03

Locations

US(7)