A Combined School- and Home-Based Sleep Promotion Program

Prevention Strategies to Enhance Young Children's Sleep Development - Part 1

The goal of this single group trial is to test the feasibility and acceptability of a combined school- and home-based sleep promotion program for young children prior to the kindergarten transition.

Study Overview

• Status: Completed
• Conditions: Sleep
• Intervention / Treatment: Behavioral: Rested & Ready to Learn

Detailed Description

This single group pilot study will test a combined school- and home-based sleep promotion intervention designed to improve young children's sleep and classroom behavior. All participants will receive the intervention. Intervention content will be delivered via text message to parents' phones and in the classroom. The primary aim of this study is to assess the feasibility and acceptability of the intervention. The secondary aim is to assess the preliminary signal of effect on children's sleep and classroom behavior. Findings from this study will inform any necessary intervention modifications prior to a pilot randomized controlled trial.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Columbia, South Carolina, United States, 29208
      • University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Child between the ages of 4-6 years
• Currently enrolled in a participating school's 4-year-old kindergarten (4K) classroom
• Parent/guardian willing to complete questionnaires in English
• Parent/guardian must have access to a mobile phone with texting capability

Exclusion Criteria:

• Parent or child has a medical condition that impairs their ability to participate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Rested & Ready to Learn; All participants will receive the four-week Rested & Ready to Learn sleep promotion program which includes text messaging to parents, home activities for parents and children to complete together, and brief classroom lessons.

Behavioral: Rested & Ready to Learn; The intervention arm targets improving young children's sleep by providing parents with sleep education and activities to do at home with their child. Classroom teachers will also deliver a brief lesson aligned with intervention topics to reinforce key messaging in the classroom. The sleep intervention will focus on the benefits of sleep (physical health, social-emotional health, classroom participation/learning), creating and sticking to a bedtime routine, screen use before bed, and developmentally appropriate sleep behavior.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trial-related feasibility - recruitment capability	Recruitment capability will be measured by the proportion of eligible children who enroll at baseline.	Through recruitment period, up to 6 weeks
Trial-related feasibility - retention	Retention will be measured by the proportion of enrolled children who remain in the study through the length of the intervention. Reasons for dropout will also be assessed.	Weekly through study completion (weeks 1-5)
Intervention-related feasibility - intervention fidelity	Intervention fidelity, the delivery of the intervention as originally planned, will be assessed via teacher report. Intervention fidelity will be assessed with a study-specific questionnaire to assess if all classroom components were delivered as planned.	Weekly through study completion (weeks 1-4)
Intervention-related feasibility - rate of attendance	Children's attendance at school during intervention sessions will be provided by class records.	Weekly through study completion (weeks 1-4)
Intervention-related feasibility - participant adherence to intervention (school)	School-based adherence will be assessed by a teacher-completed survey which will indicate whether or not they implemented the intervention each week.	Weekly through study completion (weeks 1-4)
Intervention-related feasibility - data collection completion rates	Data collection completion rates will be calculated to understand the feasibility of data collection protocols.	Weekly through study completion (weeks 1-4)
Intervention-related feasibility - data collection feasibility	Feasibility of data collection procedures will be assessed with qualitative feedback from parents during semi-structured interviews following the study.	Post-intervention (week 5-7)
Acceptability	Acceptability of the intervention conditions is defined as participants' perception that the intervention is satisfactory and will be assessed with short weekly questionnaires for parents and teachers. Overall acceptability will be assessed with an exit-survey consisting of Likert-scale items and open-ended responses to understand likes/dislikes, content, logistics, and feedback for future iterations. Likert-style questions will have response options ranging from 1-5 with greater scores representing higher acceptability.	Weekly through study completion (weeks 1-4), post-intervention (week 5-7)
Intervention-related feasibility - participant adherence to intervention (home)	Adherence to the home-based component will rely on link usage data to assess parent engagement with the online materials. Investigators will extract information related to the number of parents who click links from weekly material and number of parents who do not open links.	Weekly through study completion (weeks 1-4)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child sleep - device-based duration	Objective nocturnal sleep duration will be assessed using Axivity AX3 accelerometers worn on the non-dominant wrist for 7 days. Raw accelerometry data will be processed with open-source software, GGIR.	Baseline (week 0) and post-intervention (week 5)
Child sleep - device-based timing	Objective sleep timing will be assessed using Axivity AX3 accelerometers worn on the non-dominant wrist for 7 days. Raw accelerometry data will be processed with open-source software, GGIR.	Baseline (week 0) and post-intervention (week 5)
Child sleep - Bedtime Routines Questionnaire	Parents will complete the Bedtime Routines Questionnaire which contains 31 items on a 5-point Likert scale. This questionnaire results in two subscales - bedtime routine consistency and routine behaviors and environment. Higher scores indicate more consistent bedtime routines.	Baseline (week 0) and post-intervention (week 5)
Child behavior	Parents and teachers will complete the Child Self-Regulation and Behavior Questionnaire (CSBQ, ~10 min) which contains 34 items describing children's typical self-regulation and social behaviors in the home (parent version) and classroom (teacher version). Respondents describe what the child's behavior is like on a five-point scale ranging from "Not true" to "Very true." The CSBQ provides the following subscales: self-regulation, sociability, externalizing problems, internalizing problems, and prosocial behavior. The CSBQ is valid and reliable in children ages 3-6 years.	Baseline (week 0) and post-intervention (week 5)
Child inhibition	Inhibition (i.e., the ability to control behavioral impulses) will be assessed with the Go/No-Go task in which children are asked to identify fish and avoid sharks shown on the screen on an iPad as part of the freely accessible Early Years Toolbox. An impulse control score is calculated (% Go Accuracy x % No-Go Accuracy), which reflects the child's ability to withhold their response in the context of the strength of that typical (pre-potent) response.	Baseline (week 0) and post-intervention (week 5)
Child working memory	Working memory (i.e., amount of information that can be coordinated in the mind) will be assessed with the Mr. Ant task in which children will recall and identify the location of colorful stickers on Mr. Ant's body on an iPad as part of the freely accessible Early Years Toolbox. For the Mr Ant task, scores are calculated using a point score calculated as: beginning from level 1, one point for each consecutive level in which at least two of the three trials were performed accurately, plus 1/3 of a point for all correct trials thereafter.	Baseline (week 0) and post-intervention (week 5)
Child cognitive flexibility	Cognitive flexibility (i.e., the ability to control and redirect attention) will be assessed with the Card Sorting task in which children will sort cards by color and then shape on an iPad as part of the freely accessible Early Years Toolbox. For the Card Sorting task, investigators tend to review the accuracy of Block 1 (pre-switch) and Block 2 (post-switch). Since a post-switch accuracy score intends to index the extent to which a child could successfully switch from one sorting rule to the next, investigators will swap the two scores if the post-switch accuracy is larger than the pre-switch accuracy. This ensures that final post-switch scores (Block 2 + Block 3) reflects the child's ability to successfully switch between sorting rules.	Baseline (week 0) and post-intervention (week 5)

Collaborators and Investigators

• Sponsor: University of South Carolina
• Collaborators: National Institute of General Medical Sciences (NIGMS)
• Investigators: Principal Investigator: Sarah Burkart, PhD, University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2024
• Primary Completion (Actual): June 28, 2024
• Study Completion (Actual): February 1, 2025

Study Registration Dates

• First Submitted: October 11, 2023
• First Submitted That Met QC Criteria: November 12, 2023
• First Posted (Actual): November 15, 2023

Study Record Updates

• Last Update Posted (Actual): May 14, 2025
• Last Update Submitted That Met QC Criteria: May 9, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: Pro00125230; 5P20GM130420 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No