Rested & Ready to Learn

University of South Carolina

Status: Active, not recruiting

Conditions: Sleep

Treatments: Behavioral: Rested & Ready to Learn

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06882005

5P20GM130420 (U.S. NIH Grant/Contract)

Pro00138759

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 4 to 6 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Rested & Ready to Learn

Experimental group

Description:

The Rested \& Ready to Learn sleep promotion program includes text messaging to parents, home activities for parents and children to complete together, and brief classroom lessons.

Treatment:

Behavioral: Rested & Ready to Learn

Control

No Intervention group

Description:

The control group will not receive any intervention. They will be placed on a waitlist and will receive the Rested \& Ready to Learn intervention once all assessments are complete.