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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06455579
Other study ID # IRB-P00044533
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 2024
Est. completion date November 2024

Study information

Verified date June 2024
Source Boston Children's Hospital
Contact Grace Y Wang, BS
Phone 617-919-6212
Email grace.wang@childrens.harvard.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 75
Est. completion date November 2024
Est. primary completion date November 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Community healthcare providers that do not see school-aged children (4-10 years of age)

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Boston Children's Hospital Allan & Gill Gray Foundation

References & Publications (3)

Meltzer 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. Erratum In: J Pediatr Psychol. 2015 Mar;40(2):262-5. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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).
1-14 days
Secondary 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? 1-14 days
Secondary 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. 1-14 days
Secondary 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. 1-14 days
Secondary Provider Feedback on Drafted Content Feedback on their participation and their use of content, sleep health material. 1-14 days
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