Sleep Health Education for Caregivers

Overseen By Judith Owens, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Boston Children's Hospital

Disqualifiers: Moving, Not living with child

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

75 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the Bedtime Stories Sleep Health Education Program for Caregivers (BTS-C), which uses a mobile app to help caregivers of school-aged children improve sleep habits. The researchers aim to determine if the program is practical and useful, particularly for families in low-income or historically marginalized communities where such resources are limited. This trial targets caregivers who live with and care for children ages 5-11 in the Boston area and are comfortable using English. Participants will engage with interactive content, including videos and messages, over six weeks to learn about healthy sleep practices. As an unphased trial, this study offers caregivers a unique opportunity to contribute to research that could enhance sleep health education for diverse communities.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Bedtime Stories Sleep Health Education Program is safe for caregivers?

Research has shown that the Bedtime Stories Sleep Health Education Program for Caregivers (BTS-C) is generally easy for users to handle. This program uses a mobile app to send personalized sleep health tips to caregivers. Although detailed safety data remains limited, similar sleep programs for caregivers have reported no negative effects. These programs often improve sleep patterns for both caregivers and children without causing harm. As an educational program delivered through a mobile app, it is considered low-risk for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Bedtime Stories Sleep Health Education Program for Caregivers (BTS-C) because it offers a fresh approach to improving sleep health through interactive and personalized learning. Unlike traditional methods that might rely on general sleep hygiene advice, BTS-C uses an innovative mobile app featuring avatar-based interactive modules tailored to caregivers' specific goals and expectations. This personalized and engaging format, combined with targeted messages for adopting better sleep practices, aims to make learning more effective and enjoyable, potentially leading to better outcomes for caregivers.

What evidence suggests that the Bedtime Stories Sleep Health Education Program is effective for improving sleep behavior in caregivers?

Research has shown that improving children's sleep habits can significantly enhance their sleep, especially when caregivers identify sleep problems. In this trial, participants will use the Bedtime Stories Sleep Health Education Program for Caregivers (BTS-C), a mobile app designed to enhance sleep habits through personalized, interactive learning. Early results suggest that focused sleep advice can be effective, particularly when tailored to caregivers' specific needs. This program aims to provide accessible and practical support for families in underserved and low-income communities. Although direct data on BTS-C's effectiveness is limited, the method relies on proven sleep education strategies. ^{1 2 4 6 7}

Who Is on the Research Team?

Judith Owens, MD

Principal Investigator

Boston Children's Hospital

Are You a Good Fit for This Trial?

This trial is for caregivers of school-aged children (5-11 years) who are fluent in English and receive care at participating community healthcare centers in the Boston area. It focuses on those from historically marginalized or low-income communities.

Inclusion Criteria

I am fluent in English.

I care for a child aged 5-11 who is treated at a Boston area healthcare center.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in the Bedtime Stories Sleep Health Education Program using a mobile application over 6 weeks

6 weeks

Asynchronous online modules

Follow-up

Participants are monitored for changes in sleep health knowledge, perceptions, and practices, as well as child sleep health and caregiver stress

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Bedtime Stories Sleep Health Education Program for Caregivers (BTS-C)

Trial Overview The Bedtime Stories Sleep Health Education Program for Caregivers (BTS-C) is being tested to see if it can improve sleep behavior through tailored messaging via mobile health technology.

How Is the Trial Designed?

Group I: Sleep Health Education Program for Caregivers Experimental Treatment 1 Intervention

The BTS-C is an online sleep health education program that is located on a mobile application. The BTS-C utilizes asynchronous avatar-based interactive learning and educational content and videos that are tailored to the caregivers' goals and expectations, paired with targeting messages for change surrounding principles of sleep health practices. The modules will be completed over the course of 6 weeks.

Who Is Running the Clinical Trial?

Boston Children's Hospital

Lead Sponsor

Trials

801

Recruited

5,584,000+

Citations

1. trial.medpath.com trial.medpath.com/clinical-trial/84b5c06972a5b716/nct06618040-tailored-sleep-health-messaging-caregivers

Tailored Sleep Health Messaging for Caregivers - MedPath To address this significant gap, this project seeks to examine the feasibility, acceptability, and usability of the Bedtime Stories Sleep Health Education ...

2. withpower.com withpower.com/trial/phase-sleep-9-2024-9f208

Sleep Health Education for Caregivers Trial Overview The Bedtime Stories Sleep Health Education Program for Caregivers (BTS-C) is being tested to see if it can improve sleep behavior through ...

3. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT04536766

Impact of Bed Provision and Sleep Education | ... The Beds for Kids program provides beds, bedding, and written healthy sleep education to families living at or below 100% of the federal poverty line and ...

4. ctv.veeva.com ctv.veeva.com/study/bedtime-stories-a-sleep-health-education-program-for-healthcare-providers

A Sleep Health Education Program for Healthcare Providers The purpose of this protocol it assess the effectiveness of the Bedtime Stories Sleep Health Education Program in Community Healthcare Providers ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8974371/

Sleep Well! An adapted behavioral sleep intervention ... Empirical reviews show that behavioral sleep interventions significantly improve early childhood sleep, including caregiver-perceived child sleep problems and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11903974/

The Use of Technology and Telehealth to Improve ... Caregivers in both programs reported improvements in their child's bedtime resistance and anxiety, sleep onset delay, and caregiver quality of life. However, no ...

7. clinicaltrials.gov clinicaltrials.gov/ProvidedDocs/44/NCT03392844/Prot_SAP_000.pdf

Beds for Kids Program: Impact on Child Sleep and Family ... study data. To maintain patient safety, validated questionnaires of child behavior (CBCL) and caregiver mood (CES-D-R) will be scored and ...