A Combined School- and Home-Based Sleep Promotion Program

NCT06131944 | Completed

• 2 other identifiers: Pro001252305P20GM130420
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sleep

Outcome Measures

Primary Outcomes (9)

• 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 (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)

• 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)

Secondary Outcomes (7)

• Child sleep - device-based duration

  Baseline (week 0) and post-intervention (week 5)

• Child sleep - device-based timing

  Baseline (week 0) and post-intervention (week 5)

• Child sleep - Bedtime Routines Questionnaire

  Baseline (week 0) and post-intervention (week 5)

• Child behavior

  Baseline (week 0) and post-intervention (week 5)

• Child inhibition

  Baseline (week 0) and post-intervention (week 5)

Study Arms (1)

Rested & Ready to Learn

EXPERIMENTAL

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

Interventions

Rested & Ready to Learn 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.

Rested & Ready to Learn

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of South Carolina: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

University of South Carolina

Columbia, South Carolina, 29208, United States

Location

Study Officials

• Sarah Burkart, PhD

  University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 11, 2023
• First Posted: November 15, 2023
• Study Start: March 26, 2024
• Primary Completion: June 28, 2024
• Study Completion: February 1, 2025
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)