Sleep Health Literacy in Head Start (SLEEP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03556462|
Recruitment Status : Active, not recruiting
First Posted : June 14, 2018
Last Update Posted : August 6, 2021
|Condition or disease||Intervention/treatment||Phase|
|Sleep||Other: Sleep Health Education||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||538 participants|
|Intervention Model:||Crossover Assignment|
|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.|
|Masking:||None (Open Label)|
|Official Title:||Increasing Sleep Health Literacy: A Social Ecological Approach|
|Actual Study Start Date :||May 21, 2018|
|Actual Primary Completion Date :||October 30, 2019|
|Estimated Study Completion Date :||February 3, 2022|
Experimental: 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
Other: Sleep Health Education
Parents and children receive sleep health education
No Intervention: Control Period
No Intervention, but data collection
- Child Sleep Duration: Intervention vs. Control (Total) [ Time Frame: 9 months ]
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
- Child Sleep Duration: >30 Minutes [ Time Frame: 9 months ]Hypothesis: Intervention group will sleep >= 30 minutes longer than Controls difference in duration between Intervention vs. Control periods
- Child sleep difficulties [ Time Frame: 12 months ]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.
- Parent KASB (Knowledge/Attitudes/Self-Efficacy/Beliefs) [ Time Frame: 12 months ]
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.
- Child Sleep Duration: 1 Year Follow-Up [ Time Frame: 12 months ]Hypothesis: Intervention group will sleep >= 15 minutes longer than Controls at 1 Year Follow-Up
- Classroom Climate [ Time Frame: 9 months ]
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03556462
|United States, New York|
|Kingsbridge Heights Community Center|
|Bronx, New York, United States, 10463|
|Yeled v"Yalda Early Childhood Center, Inc.|
|Brooklyn, New York, United States, 11218|
|Committee for Early Childhood Development D.D.C. incl|
|Hollis, New York, United States, 11423|
|East Harlem Council for Human Services, Inc.|
|Manhattan, New York, United States, 10035|
|Cattaraugus and Wyoming Counties Project Head Start|
|Olean, New York, United States, 14760|
|Agri-Business Child Development|
|Schenectady, New York, United States, 12308|
|Family Services of Westchester|
|White Plains, New York, United States, 10603|
|Principal Investigator:||Karen Bonuck, PhD||Albert Einstein College of Medicine|