Rested & Ready to Learn for Sleep

Overseen By E. Rebekah Siceloff, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of South Carolina

Disqualifiers: Medical condition impairing participation

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 17

80 Participants Needed

Trial Summary

What is the purpose of this trial?

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

This trial is for young children who are about to start kindergarten. It's designed to see if a sleep program at school and home can help them rest better. The specific eligibility criteria aren't provided, so we assume it's open to kids of this age group without restrictions mentioned.

Inclusion Criteria

My child's guardian can complete English questionnaires.

My child is between 4 and 6 years old.

My child is enrolled in a 4-year-old kindergarten program.

Exclusion Criteria

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

Up to 6 weeks

Intervention

Participants receive the Rested & Ready to Learn sleep promotion program, including text messaging to parents, home activities, and classroom lessons

4 weeks

Weekly sessions

Post-intervention

Assessment of intervention acceptability and feasibility through surveys and interviews

5 weeks

Weekly assessments

Follow-up

Participants are monitored for long-term effects on sleep and behavior

12 weeks

Follow-up assessments at week 17

Treatment Details

Interventions

• Rested & Ready to Learn

Trial Overview The 'Rested & Ready to Learn' program is being tested in this study. It's a pilot randomized controlled trial, which means by chance, some kids will get the sleep promotion program and others won't, allowing researchers to compare outcomes.

Participant Groups

Group I: Rested & Ready to Learn Experimental Treatment 1 Intervention

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.

Group II: Control Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of South Carolina

Lead Sponsor

Trials

233

Recruited

122,000+

National Institute of General Medical Sciences (NIGMS)

Collaborator

Trials

315

Recruited

251,000+