NCT06455579

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2024

Completed
21 days until next milestone

First Posted

Study publicly available on registry

June 12, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

October 9, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

August 28, 2025

Status Verified

August 1, 2025

Enrollment Period

9 months

First QC Date

May 22, 2024

Last Update Submit

August 22, 2025

Conditions

SleepHealth-Related Behavior

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Provider Acceptability

    1-14 days

  • Provider Feasibility (number of modules)

    1-14 days

  • Provider Feasibility (time spent)

    1-14 days

  • Provider Feedback on Drafted Content

    1-14 days

Study Arms (1)

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.

Behavioral: Bedtime Stories Sleep Health Education Program for community healthcare providers (BTS-HP)

Interventions

Bedtime Stories Sleep Health Education Program for community healthcare providers (BTS-HP)BEHAVIORAL

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.

Sleep Health Education Program for Healthcare Providers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Community healthcare providers that do not see school-aged children (4-10 years of age)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (3)

  • 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.

    PMID: 11533369BACKGROUND

  • 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: 21546852BACKGROUND

  • 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.

    PMID: 24947271BACKGROUND

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Judith Owens, MD

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR

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

May 22, 2024

First Posted

June 12, 2024

Study Start

October 9, 2024

Primary Completion

July 1, 2025

Study Completion

July 1, 2025

Last Updated

August 28, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)