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SleepNCT06131944

A Combined School- and Home-Based Sleep Promotion Program

A study testing Rested & Ready to Learn in people with Sleep, run by University of South Carolina at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 4 to 6 yearsHealthy volunteers can take part
Conditions the study is for
Sleep
What is being tested?
Rested & Ready to Learn
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
1 siteUnited States
Study dates
26 Mar 2024to 1 Feb 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 6 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of South Carolina

    Columbia, South Carolina, 29208

Other trials in United States

About this study

Official title: Prevention Strategies to Enhance Young Children's Sleep Development - Part 1

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.

Read the detailed description

This single group pilot study will test a combined school- and home-based sleep promotion intervention designed to improve young children's sleep and classroom behavior. All participants will receive the intervention. 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 pilot randomized controlled trial.

Conditions
Sleep
Being tested
Rested & Ready to Learn

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rested & Ready to LearnBehavioural

    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.

Study groups in NCT06131944
Study groupRoleWhat they receive
Rested & Ready to LearnExperimentalAll 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.
Receives: Behavioral: Rested & Ready to Learn

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Trial-related feasibility - recruitment capability

    Recruitment capability will be measured by the proportion of eligible children who enroll at baseline.

    Measured: Through recruitment period, up to 6 weeks

  2. 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.

    Measured: Weekly through study completion (weeks 1-5)

  3. 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.

    Measured: Weekly through study completion (weeks 1-4)

  4. Intervention-related feasibility - rate of attendance

    Children's attendance at school during intervention sessions will be provided by class records.

    Measured: Weekly through study completion (weeks 1-4)

  5. 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.

    Measured: Weekly through study completion (weeks 1-4)

  6. 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.

    Measured: Weekly through study completion (weeks 1-4)

  7. Intervention-related feasibility - data collection completion rates

    Data collection completion rates will be calculated to understand the feasibility of data collection protocols.

    Measured: Weekly through study completion (weeks 1-4)

  8. 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.

    Measured: Post-intervention (week 5-7)

  9. 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.

    Measured: Weekly through study completion (weeks 1-4), post-intervention (week 5-7)

Secondary outcomes (7)

  1. Child sleep - device-based duration

    Objective nocturnal sleep duration will be assessed using Axivity AX3 accelerometers worn on the non-dominant wrist for 7 days. Raw accelerometry data will be processed with open-source software, GGIR.

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

  2. Child sleep - device-based timing

    Objective sleep timing will be assessed using Axivity AX3 accelerometers worn on the non-dominant wrist for 7 days. Raw accelerometry data will be processed with open-source software, GGIR.

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

  3. Child sleep - Bedtime Routines Questionnaire

    Parents will complete the Bedtime Routines Questionnaire which contains 31 items on a 5-point Likert scale. This questionnaire results in two subscales - bedtime routine consistency and routine behaviors and environment. Higher scores indicate more consistent bedtime routines.

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

  4. Child behavior

    Parents and teachers will complete the Child Self-Regulation and Behavior Questionnaire (CSBQ, ~10 min) which contains 34 items describing children's typical self-regulation and social behaviors in the home (parent version) and classroom (teacher version). Respondents describe what the child's behavior is like on a five-point scale ranging from "Not true" to "Very true." The CSBQ provides the following subscales: self-regulation, sociability, externalizing problems, internalizing problems, and prosocial behavior. The CSBQ is valid and reliable in children ages 3-6 years.

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

  5. Child inhibition

    Inhibition (i.e., the ability to control behavioral impulses) will be assessed with the Go/No-Go task in which children are asked to identify fish and avoid sharks shown on the screen on an iPad as part of the freely accessible Early Years Toolbox. An impulse control score is calculated (% Go Accuracy x % No-Go Accuracy), which reflects the child's ability to withhold their response in the context of the strength of that typical (pre-potent) response.

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

  6. Child working memory

    Working memory (i.e., amount of information that can be coordinated in the mind) will be assessed with the Mr. Ant task in which children will recall and identify the location of colorful stickers on Mr. Ant's body on an iPad as part of the freely accessible Early Years Toolbox. For the Mr Ant task, scores are calculated using a point score calculated as: beginning from level 1, one point for each consecutive level in which at least two of the three trials were performed accurately, plus 1/3 of a point for all correct trials thereafter.

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

  7. Child cognitive flexibility

    Cognitive flexibility (i.e., the ability to control and redirect attention) will be assessed with the Card Sorting task in which children will sort cards by color and then shape on an iPad as part of the freely accessible Early Years Toolbox. For the Card Sorting task, investigators tend to review the accuracy of Block 1 (pre-switch) and Block 2 (post-switch). Since a post-switch accuracy score intends to index the extent to which a child could successfully switch from one sorting rule to the next, investigators will swap the two scores if the post-switch accuracy is larger than the pre-switch accuracy. This ensures that final post-switch scores (Block 2 + Block 3) reflects the child's ability to successfully switch between sorting rules.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Nov 2023
  2. Study start26 Mar 2024
  3. Primary completion28 Jun 2024
  4. Study completion1 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06131944
Sponsor's protocol ID
Pro00125230
Other IDs
5P20GM130420
Status last verified
May 2025
First submitted
11 Oct 2023
Last updated
14 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Rested & Ready to Learn in people with Sleep, run by University of South Carolina at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Trial-related feasibility - recruitment capability (time frame: Through recruitment period, up to 6 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06131944.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.

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