Clinical trial NCT06618040: Bedtime Stories: Tailored Sleep Health Messaging for Caregivers
Official title: Bedtime Stories: Tailored Sleep Health Messaging for Caregivers
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sleep
Health-Related Behavior
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2024-10-01
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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 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.

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

Primary outcomes:
measure: Knowledge, Perceptions, and Practices
timeFrame: Follow Up, after 8 weeks
measure: Feasibility, acceptability, and usability
timeFrame: Follow Up, after 8 weeks
measure: Assessment of Child Sleep
timeFrame: 1 week baseline, 1 week follow up, entire study
measure: Child Sleep Health
timeFrame: Baseline (at week 0), Follow Up (after 8 weeks)
Secondary outcomes:
measure: Child Sleep Environment
timeFrame: Baseline (at week 0)
measure: Child Sleep Disturbance Impairments
timeFrame: Baseline (at week 0), Follow Up (after 8 weeks)
measure: Assessment of parent/caregiver sleep
timeFrame: Baseline (at week 0), Follow Up (after 8 weeks), Entire Study (8 weeks)
measure: Caregiver Stress
timeFrame: Baseline (at week 0), Follow Up (after 8 weeks)
Other outcomes:
Locations:
Study officials:
affiliation: Boston Children's Hospital
name: Judith Owens, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.