Bedtime Stories: Tailored Sleep Health Messaging for Caregivers

To date, there are very few established sleep health education models targeting caregivers of school-aged children from historically marginalized and/or low income communities. To address this significant gap, this project seeks to examine the feasibility, acceptability, and usability of the Bedtime Stories Sleep Health Education Program to improve sleep behavior. Bedtime Stories is a multi-stakeholder (health care providers, school-aged children, and caregivers of school-aged children) and a multi-component program. The caregiver component of the program utilizes mobile health technology with targeted and tailored sleep health messaging for caregivers of school-aged children. Addressing these aims will help to mitigate gaps in the delivery of health care services to caregivers and families in low income and historically marginalized communities, where services and interventions are scant.

Study Overview

• Status: Recruiting
• Conditions: Sleep; Health-Related Behavior
• Intervention / Treatment: Behavioral: Bedtime Stories Sleep Health Education Program for Caregivers (BTS-C)

Detailed Description

Healthy sleep practices are a fundamental component of sleep education interventions designed to prevent sleep problems from developing (Masten et al., 2006) and aide in managing existing sleep disorders such as insomnia in children (Moore et al., 2007). Although poor sleep is linked to a host of negative outcomes, sleep health may also be viewed in a positive light, i.e., "sleep wellness" that places the emphasis on the benefits of good sleep and its importance to overall health maintenance and improvement. Indeed, both the positive and negative aspects of sleep are highly relevant with regards to developing sleep health educational programs, while providing concrete targets for health promotion, wellness and prevention. Fostering healthy sleep habits in children and adolescents builds the foundation for healthy sleep habits in adulthood (Galland et al., 2010). A major challenge to identifying sleep concerns in children is that identification often relies on parent reported concerns, professional clinical judgment, and the presence of symptomatology that changes with age. The early diagnosis of sleep concerns is a key factor to enable access to interventions that improve sleep health. To address this critical gap requires targeted interventions tailored to healthcare providers, particularly those serving communities and populations most in need.

Interventions for caregivers focused on sleep health, including sleep health practice, building and supporting routines, and consistent sleep schedules are integral features to sleep. Settings to promote healthy sleep practices including well-child visits. The well-child visit is an opportunity to educate parents about normal sleep in children and provide strategies to prevent sleep problems from either developing, or if problems already exist from becoming chronic. Community health centers which serve both children and adults, afford unique opportunities to incorporate screening and the prevention of sleep disorders; and deliver coordinated health messages to parents and children in order to effect positive behavioral change within the entire family.

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Grace Y Wang, BS; Phone Number: 617-919-6212; Email: grace.wang@childrens.harvard.edu
• Study Contact Backup: Name: Judith Owens, MD; Email: judith.owens@childrens.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Boston Children's Hospital
      • Contact: Grace Y Wang; Phone Number: 617-919-6212; Email: Grace.Wang@childrens.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 18 years old or over
• Caregivers of school-aged children (5-11 years of age) that receive care at participating community healthcare centers in the Boston area
• English fluency

Exclusion Criteria:

• Planning on moving within the next 3 months
• Does not live in the home with the child

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Sleep Health Education Program for Caregivers; 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.

Behavioral: Bedtime Stories Sleep Health Education Program for Caregivers (BTS-C); The BTS-C includes 6 educational modules on different topics related to sleep health: principles of healthy sleep practices include sleep routines, the sleep environment, considerations for screen time, timing of sleep and activities surrounding sleep, expectations for healthy sleep and sleep duration. Caregivers will also receive a combination of tailored messages or prompts to explore progress, identify strategies for change, and goal setting.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knowledge, Perceptions, and Practices	Using the parent Knowledge, Attitudes, Self-Efficacy, and Beliefs scale (adapted questionnaire), 19-item questionnaire; minimum score is 19 and maximum score is 95. A higher score means better sleep habits.	Follow Up, after 8 weeks
Feasibility, acceptability, and usability	Using the Brief Feedback questionnaire (BFQ), 15-item questionnaire; total score	Follow Up, after 8 weeks
Assessment of Child Sleep	Using a sleep diary (1-week; sleep duration, total sleep time) and the Fitbit Inspire 3 (sleep duration, sleep efficiency, regulatory of sleep time)	1 week baseline, 1 week follow up, entire study
Child Sleep Health	Using the Child Sleep Habits Questionnaire: 22-item parent report; Bedtime resistance, sleep onset delay, sleep duration, sleep anxiety, night wakings, parasomnias, sleep disordered breathing, daytime sleepiness; total score	Baseline (at week 0), Follow Up (after 8 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child Sleep Environment	Using the Children's Adolescents' Sleep Environment Scale (CASES): 13-item parent report; total score	Baseline (at week 0)
Child Sleep Disturbance Impairments	Using the PROMIS: 8-item parent report, total score; and the disturbance 8-item parent report, total score; impairment	Baseline (at week 0), Follow Up (after 8 weeks)
Assessment of parent/caregiver sleep	Using the Pittsburgh Sleep Quality Index (PSQI), 19-item questionnaire: sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, use of sleeping medication, daytime dysfunction, total score; and the Fitbit Inspire 3: Baseline and follow up; sleep duration, sleep efficiency, regulatory of sleep time	Baseline (at week 0), Follow Up (after 8 weeks), Entire Study (8 weeks)
Caregiver Stress	Using the Parent Stress Index-Short Form (PSI), 36-item questionnaire: parent distress, parent-child dysfunctional interaction, difficult child; total score	Baseline (at week 0), Follow Up (after 8 weeks)

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Investigators: Principal Investigator: Judith Owens, MD, Boston Children's Hospital

Publications and helpful links

General Publications

• Owens JA, Jones C. Parental knowledge of healthy sleep in young children: results of a primary care clinic survey. J Dev Behav Pediatr. 2011 Jul-Aug;32(6):447-53. doi: 10.1097/DBP.0b013e31821bd20b.
• Mindell JA, Bartle A, Wahab NA, Ahn Y, Ramamurthy MB, Huong HT, Kohyama J, Ruangdaraganon N, Sekartini R, Teng A, Goh DY. Sleep education in medical school curriculum: a glimpse across countries. Sleep Med. 2011 Oct;12(9):928-31. doi: 10.1016/j.sleep.2011.07.001. Epub 2011 Sep 16.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2025
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 30, 2026

Study Registration Dates

• First Submitted: August 14, 2024
• First Submitted That Met QC Criteria: September 25, 2024
• First Posted (Actual): October 1, 2024

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 12, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior; Health Behavior; Health Care Facilities Workforce and Services; Health Personnel; Caregivers
• Other Study ID Numbers: IRB-P00047237

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No