Bedtime Stories: Tailored Sleep Health Messaging for Caregivers

NCT06618040 | Recruiting

• 1 other identifier: IRB-P00047237
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sleep; Health-Related Behavior

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Child Sleep Environment

  Baseline (at week 0)

• Child Sleep Disturbance Impairments

  Baseline (at week 0), Follow Up (after 8 weeks)

• Assessment of parent/caregiver sleep

  Baseline (at week 0), Follow Up (after 8 weeks), Entire Study (8 weeks)

• Caregiver Stress

  Baseline (at week 0), Follow Up (after 8 weeks)

Study Arms (1)

Sleep Health Education Program for Caregivers

EXPERIMENTAL

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)

Interventions

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

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.

Sleep Health Education Program for Caregivers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Related Publications (2)

• 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.

  PMID: 21924951 BACKGROUND

• 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.

  PMID: 21546852 BACKGROUND

MeSH Terms

Conditions

Health Behavior

Interventions

Caregivers

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Health Personnel; Health Care Facilities Workforce and Services

Study Officials

• Judith Owens, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Grace Y Wang, BS

CONTACT

617-919-6212; grace.wang@childrens.harvard.edu

Judith Owens, MD

CONTACT

judith.owens@childrens.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology

Study Record Dates

• First Submitted: August 14, 2024
• First Posted: October 1, 2024
• Study Start: April 1, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 30, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)