SleepNCT06455579
Bedtime Stories: A Sleep Health Education Program for Healthcare Providers
A study testing Bedtime Stories Sleep Health Education Program for community healthcare providers (BTS-HP) in people with Sleep and Health-Related Behavior, run by Boston Children's Hospital at 1 site in United States.
Trial summary
This is a pilot intervention of the Bedtime Stories Sleep Health Education Program for healthcare providers serving school aged children and their caregivers. The intervention uses a pre-post design across participants. 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 community healthcare providers (BTS-HP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Oct 2024to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Community Healthcare Provider (physicians, residents, registered nurses, nurse practitioners) at participating community healthcare centers in the Boston area
- Serve families with school-aged (4-10 years of age) children
- English fluency
Who cannot join
- Community healthcare providers that do not see school-aged children (4-10 years of age)
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
This is a pilot intervention of the Bedtime Stories Sleep Health Education Program for healthcare providers serving school aged children and their caregivers. The intervention uses a pre-post design across participants.
Read the detailed description
To date, there are no established sleep health education programs for healthcare providers. To address this gap, the investigators previously conducted semi-structured interviews with community-based healthcare providers to improve our knowledge and understanding of healthcare providers' attitudes and beliefs about sleep health, factors that may contribute to poor sleep health, and identify potential sleep health promotion strategies for low income, racial and ethnic minority children and their families. Data from those sessions helped to inform and refine content to develop a sleep health education program for community healthcare providers. The purpose of this protocol it assess the effectiveness of the Bedtime Stories Sleep Health Education Program in Community Healthcare Providers (BTS-HP).
Healthcare providers from participating community healthcare centers will be invited to participate. Once a healthcare provider expresses interest in participating, they will receive a REDCap link to provide their informed consent. The provider will then complete a short demographic questionnaire via REDCap. Once the healthcare provider consents and completes the short questionnaire, they will receive a secure link to the Bedtime Stories Sleep Health Education Program for Healthcare Providers (BTS-HP). The BTS-HP is an online sleep health education program supported by the Boston Children's Hospital Department of Education (CE Courses - BCH Education (childrenshospital.org). The provider will also receive access to an educational webinar on Melatonin. The provider can participate all modules and the webinar in one sitting or overtime. Once the provider completes the online modules, they will immediately receive an email with a REDCap link to complete their post-participation questionnaire.
- Conditions
- Sleep, Health-Related Behavior
- Being tested
- Bedtime Stories Sleep Health Education Program for community healthcare providers (BTS-HP)
- 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 community healthcare providers (BTS-HP)Behavioural
The sleep health education program includes 6 educational modules on different topics related to sleep health: (1) Basics of Sleep, 2) Sleep and Development, 3) Sleep Health, 4) Consequences of Deficient Sleep, 5) Sleep Health Disparities, and 6) Sleep Screening and Evaluation.
| Study group | Role | What they receive |
|---|---|---|
| Sleep Health Education Program for Healthcare Providers | Experimental | The BTS-HP is an online sleep health education program supported by the Boston Children's Hospital Department of Education (CE Courses - BCH Education (childrenshospital.org). The provider will also receive access to an educational webinar on Melatonin. The provider can participate all modules and the webinar in one sitting or overtime. Receives: Behavioral: Bedtime Stories Sleep Health Education Program for community healthcare providers (BTS-HP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Provider knowledge, perceptions, and practices of sleep health
Changes in self-reported knowledge, attitudes, confidence, intent to change practice (questions included in the post participation questionnaire). Retrospective pre-post survey.
The scale is named "Sleep Questions for Retrospective Pre-Post Survey". The minimum value is 10 and the maximum value is 55. A higher score indicates more confidence in sleep health knowledge (a better outcome).
Measured: 1-14 days
Secondary outcomes (4)
Provider Acceptability
Sample questions BTS-HP experience survey (e.g. questions: How was easy the training to use? How was this training in anticipatory guidance?
Measured: 1-14 days
Provider Feasibility (number of modules)
Monitor access and completion of modules by counting the number of modules accessed and/or completed for each provider through the online portal.
Measured: 1-14 days
Provider Feasibility (time spent)
Monitor access and completion of modules by measuring the time spent on each module for each provider through the online portal.
Measured: 1-14 days
Provider Feedback on Drafted Content
Feedback on their participation and their use of content, sleep health material.
Measured: 1-14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start9 Oct 2024
- Primary completion1 Jul 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Allan & Gill Gray Foundation
- 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
- NCT06455579
- Sponsor's protocol ID
- IRB-P00044533
- Status last verified
- Aug 2025
- First submitted
- 22 May 2024
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Owens JA. The practice of pediatric sleep medicine: results of a community survey. Pediatrics. 2001 Sep;108(3):E51. doi: 10.1542/peds.108.3.e51.
PubMed 11533369Owens 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 21546852Meltzer LJ, Mindell JA. Systematic review and meta-analysis of behavioral interventions for pediatric insomnia. J Pediatr Psychol. 2014 Sep;39(8):932-48. doi: 10.1093/jpepsy/jsu041. Epub 2014 Jun 19.
PubMed 24947271
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bedtime Stories: A Sleep Health Education Program for Healthcare Providers
- ClinicalTrials.gov ID
- NCT06455579
- Acronym / sponsor ID
- IRB-P00044533
- Conditions
- Sleep, Health-Related Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- Allan & Gill Gray Foundation
- Study start
- 9 Oct 2024 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 12 Jun 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.
This is a pilot intervention of the Bedtime Stories Sleep Health Education Program for healthcare providers serving school aged children and their caregivers. The intervention uses a pre-post design across participants.
Detailed description
To date, there are no established sleep health education programs for healthcare providers. To address this gap, the investigators previously conducted semi-structured interviews with community-based healthcare providers to improve our knowledge and understanding of healthcare providers' attitudes and beliefs about sleep health, factors that may contribute to poor sleep health, and identify potential sleep health promotion strategies for low income, racial and ethnic minority children and their families. Data from those sessions helped to inform and refine content to develop a sleep health education program for community healthcare providers. The purpose of this protocol it assess the effectiveness of the Bedtime Stories Sleep Health Education Program in Community Healthcare Providers (BTS-HP).
Healthcare providers from participating community healthcare centers will be invited to participate. Once a healthcare provider expresses interest in participating, they will receive a REDCap link to provide their informed consent. The provider will then complete a short demographic questionnaire via REDCap. Once the healthcare provider consents and completes the short questionnaire, they will receive a secure link to the Bedtime Stories Sleep Health Education Program for Healthcare Providers (BTS-HP). The BTS-HP is an online sleep health education program supported by the Boston Children's Hospital Department of Education (CE Courses - BCH Education (childrenshospital.org). The provider will also receive access to an educational webinar on Melatonin. The provider can participate all modules and the webinar in one sitting or overtime. Once the provider completes the online modules, they will immediately receive an email with a REDCap link to complete their post-participation questionnaire.
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 Healthcare Providers | Experimental | Behavioral: Bedtime Stories Sleep Health Education Program for community healthcare providers (BTS-HP)The BTS-HP is an online sleep health education program supported by the Boston Children's Hospital Department of Education (CE Courses - BCH Education (childrenshospital.org). The provider will also receive access to an educational webinar on Melatonin. The provider can participate all modules and the webinar in one sitting or overtime. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years old or over
- Community Healthcare Provider (physicians, residents, registered nurses, nurse practitioners) at participating community healthcare centers in the Boston area
- Serve families with school-aged (4-10 years of age) children
- English fluency
Key exclusion criteria (1 listed)
- Community healthcare providers that do not see school-aged children (4-10 years of age)
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 community healthcare providers (BTS-HP)The sleep health education program includes 6 educational modules on different topics related to sleep health: (1) Basics of Sleep, 2) Sleep and Development, 3) Sleep Health, 4) Consequences of Deficient Sleep, 5) Sleep Health Disparities, and 6) Sleep Screening and Evaluation. | Behavioural | Sleep Health Education Program for Healthcare Providers |
Primary outcome
Provider knowledge, perceptions, and practices of sleep health
Time frame: 1-14 days
Changes in self-reported knowledge, attitudes, confidence, intent to change practice (questions included in the post participation questionnaire). Retrospective pre-post survey. The scale is named "Sleep Questions for Retrospective Pre-Post Survey". The minimum value is 10 and the maximum value is 55. A higher score indicates more confidence in sleep health knowledge (a better outcome).
4 secondary outcomes
Provider Acceptability
Time frame: 1-14 days
Provider Feasibility (number of modules)
Time frame: 1-14 days
Provider Feasibility (time spent)
Time frame: 1-14 days
Provider Feedback on Drafted Content
Time frame: 1-14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Background: PubMed 11533369Owens JA. The practice of pediatric sleep medicine: results of a community survey. Pediatrics. 2001 Sep;108(3):E51. doi: 10.1542/peds.108.3.e51.
- 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.
- Background: PubMed 24947271Meltzer LJ, Mindell JA. Systematic review and meta-analysis of behavioral interventions for pediatric insomnia. J Pediatr Psychol. 2014 Sep;39(8):932-48. doi: 10.1093/jpepsy/jsu041. Epub 2014 Jun 19.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
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 community healthcare providers (BTS-HP) 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 4 inclusion and 1 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: finished, as of the sponsor's last update on 28 Aug 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Provider knowledge, perceptions, and practices of sleep health (time frame: 1-14 days). 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 NCT06455579, which also lists 3 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 28 Aug 2025; AzTrials last refreshed its copy on 8 Nov 2026.