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Recruiting NCT06618040

Bedtime Stories: Tailored Sleep Health Messaging for Caregivers

No phase Interventional Sleep Health-Related Behavior

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Bedtime Stories Sleep Health Education Program for Caregivers (BTS-C).
Who it may be relevant to
Registry conditions: Sleep, Health-Related Behavior. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Behavioral 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.

Primary outcome measures

  • Knowledge, Perceptions, and Practices [Time frame: Follow Up, after 8 weeks]
  • Feasibility, acceptability, and usability [Time frame: Follow Up, after 8 weeks]
  • Assessment of Child Sleep [Time frame: 1 week baseline, 1 week follow up, entire study]
  • Child Sleep Health [Time frame: Baseline (at week 0), Follow Up (after 8 weeks)]
Secondary outcome measures (4)
  • 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)]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

United States · 1 center
  • Boston Children's Hospital — Boston

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. PMID 21924951
  • 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

Identifiers

NCT: NCT06618040 · IRB-P00047237

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗