SleepNCT06618040
Bedtime Stories: Tailored Sleep Health Messaging for Caregivers
A study testing Bedtime Stories Sleep Health Education Program for Caregivers (BTS-C) in people with Sleep and Health-Related Behavior, run by Boston Children's Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep, Health-Related Behavior
- What is being tested?
- Bedtime Stories Sleep Health Education Program for Caregivers (BTS-C)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2025to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Planning on moving within the next 3 months
- Does not live in the home with the child
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Judith Owens, MD contact
United States1 site, 1 recruiting
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Grace Y Wang, 617-919-6212, Grace.Wang@childrens.harvard.edu
About this study
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.
Read the 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.
- Conditions
- Sleep, Health-Related Behavior
- Being tested
- Bedtime Stories Sleep Health Education Program for Caregivers (BTS-C)
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bedtime Stories Sleep Health Education Program for Caregivers (BTS-C)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Bedtime Stories Sleep Health Education Program for Caregivers (BTS-C) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Follow Up, after 8 weeks
Feasibility, acceptability, and usability
Using the Brief Feedback questionnaire (BFQ), 15-item questionnaire; total score
Measured: 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)
Measured: 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
Measured: Baseline (at week 0), Follow Up (after 8 weeks)
Secondary outcomes (4)
Child Sleep Environment
Using the Children's Adolescents' Sleep Environment Scale (CASES): 13-item parent report; total score
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline (at week 0), Follow Up (after 8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start1 Apr 2025
- Primary completionApr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Judith Owens, Boston Children's Hospital
- Investigators
- Judith Owens, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06618040
- Sponsor's protocol ID
- IRB-P00047237
- Status last verified
- Mar 2026
- First submitted
- 14 Aug 2024
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21924951Owens 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.
PubMed 21546852
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bedtime Stories: Tailored Sleep Health Messaging for Caregivers
- ClinicalTrials.gov ID
- NCT06618040
- Acronym / sponsor ID
- IRB-P00047237
- Conditions
- Sleep, Health-Related Behavior
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sleep Health Education Program for Caregivers | Experimental | Behavioral: Bedtime Stories Sleep Health Education Program for Caregivers (BTS-C)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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Planning on moving within the next 3 months
- Does not live in the home with the child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Sleep Health Education Program for Caregivers |
Primary outcome
Knowledge, Perceptions, and Practices
Time frame: Follow Up, after 8 weeks
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.
Feasibility, acceptability, and usability
Time frame: Follow Up, after 8 weeks
Using the Brief Feedback questionnaire (BFQ), 15-item questionnaire; total score
Assessment of Child Sleep
Time frame: 1 week baseline, 1 week follow up, entire study
Using a sleep diary (1-week; sleep duration, total sleep time) and the Fitbit Inspire 3 (sleep duration, sleep efficiency, regulatory of sleep time)
Child Sleep Health
Time frame: Baseline (at week 0), Follow Up (after 8 weeks)
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
4 secondary outcomes
Child Sleep Environment
Time frame: Baseline (at week 0)
Child Sleep Disturbance Impairments
Time frame: Baseline (at week 0), Follow Up (after 8 weeks)
Assessment of parent/caregiver sleep
Time frame: Baseline (at week 0), Follow Up (after 8 weeks), Entire Study (8 weeks)
Caregiver Stress
Time frame: Baseline (at week 0), Follow Up (after 8 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Background: PubMed 21924951Mindell 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.
- Background: PubMed 21546852Owens 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.
- Individual participant dataSharing planned: No
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Healthy Adult Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Judith Owens, MD contact
Judith Owens, MD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bedtime Stories Sleep Health Education Program for Caregivers (BTS-C) in people with Sleep and Health-Related Behavior, run by Boston Children's Hospital 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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 16 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Grace Y Wang, BS (617-919-6212, grace.wang@childrens.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge, Perceptions, and Practices (time frame: Follow Up, after 8 weeks). The study lists 4 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 NCT06618040, which also lists 2 linked publications.
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 16 Mar 2026.