A Combined School- and Home-Based Sleep Promotion Program

Sleep Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06131944
• Other study ID #: Pro00125230
• Secondary ID: 5P20GM130420
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 26, 2024
• Est. completion date: December 1, 2024

Study information

• Verified date: May 2024
• Source: University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: December 1, 2024
• Est. primary completion date: June 28, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Sleep

Intervention

Behavioral:
• Rested & Ready to Learn
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.

Locations

Country	Name	City	State
United States	University of South Carolina	Columbia	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of South Carolina	National Institute of General Medical Sciences (NIGMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Trial-related feasibility - recruitment capability	Recruitment capability will be measured by the proportion of eligible children who enroll at baseline.	Through recruitment period, up to 6 weeks
Primary	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.	Weekly through study completion (weeks 1-5)
Primary	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.	Weekly through study completion (weeks 1-4)
Primary	Intervention-related feasibility - rate of attendance	Children's attendance at school during intervention sessions will be provided by class records.	Weekly through study completion (weeks 1-4)
Primary	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.	Weekly through study completion (weeks 1-4)
Primary	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.	Weekly through study completion (weeks 1-4)
Primary	Intervention-related feasibility - data collection completion rates	Data collection completion rates will be calculated to understand the feasibility of data collection protocols.	Weekly through study completion (weeks 1-4)
Primary	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.	Post-intervention (week 5-7)
Primary	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.	Weekly through study completion (weeks 1-4), post-intervention (week 5-7)
Secondary	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.	Baseline (week 0) and post-intervention (week 5)
Secondary	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.	Baseline (week 0) and post-intervention (week 5)
Secondary	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.	Baseline (week 0) and post-intervention (week 5)
Secondary	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.	Baseline (week 0) and post-intervention (week 5)
Secondary	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.	Baseline (week 0) and post-intervention (week 5)
Secondary	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.	Baseline (week 0) and post-intervention (week 5)
Secondary	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.	Baseline (week 0) and post-intervention (week 5)