A Combined School- and Home-Based Sleep Promotion Program

NCT ID: NCT06131944

Last Updated: 2025-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-26

Study Completion Date

2025-02-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Sleep

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Rested & Ready to Learn

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of General Medical Sciences (NIGMS)

NIH

Sponsor Role collaborator

University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

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Sarah Burkart

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sarah Burkart, PhD

Role: PRINCIPAL_INVESTIGATOR

University of South Carolina

Locations

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University of South Carolina

Columbia, South Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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5P20GM130420

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00125230

Identifier Type: -

Identifier Source: org_study_id

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