Rested & Ready to Learn: Pilot RCT

Last updated: March 11, 2025
Sponsor: University of South Carolina
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Rested & Ready to Learn

Clinical Study ID

NCT06882005
Pro00138759
5P20GM130420
  • Ages 4-6
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The goal of this pilot randomized controlled trial is to test the feasibility, acceptability, and preliminary signal of effect of a combined school- and home-based sleep promotion program for young children prior to the kindergarten transition.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

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

Study Design

Total Participants: 80
Treatment Group(s): 1
Primary Treatment: Rested & Ready to Learn
Phase:
Study Start date:
February 12, 2025
Estimated Completion Date:
March 30, 2026

Study Description

This pilot randomized controlled study will test a combined school- and home-based sleep promotion intervention designed to improve young children's sleep and classroom behavior. Classrooms will be randomized to either the intervention or waitlist control group. 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 fully powered randomized controlled trial.

Connect with a study center

  • University of South Carolina

    Columbia, South Carolina 29208
    United States

    Active - Recruiting

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