Clinical trial NCT06882005: Rested & Ready to Learn
Official title: Prevention Strategies to Enhance Young Children's Sleep Development - Part 2
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Sleep
Lead sponsor: University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2025-03-18
Enrollment: 80
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Trial-related feasibility - recruitment capability
timeFrame: Through recruitment period, up to 6 weeks
measure: Trial-related feasibility - retention
timeFrame: Weekly through study completion (weeks 1-5)
measure: Intervention-related feasibility - intervention fidelity
timeFrame: Weekly through study completion (weeks 1-4)
measure: Intervention-related feasibility - rate of attendance
timeFrame: Weekly through study completion (weeks 1-4)
measure: Intervention-related feasibility - participant adherence to intervention (home)
timeFrame: Weekly through study completion (weeks 1-4)
measure: Intervention-related feasibility - participant adherence to intervention (school)
timeFrame: Weekly through study completion (weeks 1-4)
measure: Intervention-related feasibility - data collection completion rates
timeFrame: Weekly through study completion (weeks 1-4)
measure: Intervention-related feasibility - data collection feasibility
timeFrame: Post-intervention (week 5-9)
measure: Acceptability
timeFrame: Weekly through study completion (weeks 1-4), post-intervention (week 5-9)
Secondary outcomes:
measure: Child sleep - device-based duration
timeFrame: Baseline (week 0), post-intervention (week 5), follow up (week 17)
measure: Child sleep - device-based timing
timeFrame: Baseline (week 0), post-intervention (week 5), follow up (week 17)
measure: Child sleep - Bedtime Routines Questionnaire
timeFrame: Baseline (week 0), post-intervention (week 5), follow up (week 17)
measure: Child behavior
timeFrame: Baseline (week 0), post-intervention (week 5), follow up (week 17)
measure: Child inhibition
timeFrame: Baseline (week 0) and post-intervention (week 5)
measure: Child working memory
timeFrame: Baseline (week 0) and post-intervention (week 5)
measure: Child cognitive flexibility
timeFrame: Baseline (week 0) and post-intervention (week 5)
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of South Carolina
state: South Carolina
Study officials:
References: