Boston Children's Hospital
Boston, Massachusetts, 02115, United States
Location status: Recruiting
NCT Number: NCT06618040
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02115, United States
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Follow Up, after 8 weeks
Using the parent Knowledge, Attitudes, Self-Efficacy, and Beliefs scale (adapted questionnaire), 19-item questionnaire; minimum score is 19 and maximum score is 95. A higher score means better sleep habits.
Time frame: Follow Up, after 8 weeks
Using the Brief Feedback questionnaire (BFQ), 15-item questionnaire; total score
Time frame: 1 week baseline, 1 week follow up, entire study
Using a sleep diary (1-week; sleep duration, total sleep time) and the Fitbit Inspire 3 (sleep duration, sleep efficiency, regulatory of sleep time)
Time frame: Baseline (at week 0), Follow Up (after 8 weeks)
Using the Child Sleep Habits Questionnaire: 22-item parent report; Bedtime resistance, sleep onset delay, sleep duration, sleep anxiety, night wakings, parasomnias, sleep disordered breathing, daytime sleepiness; total score
Time frame: Baseline (at week 0)
Using the Children's Adolescents' Sleep Environment Scale (CASES): 13-item parent report; total score
Time frame: Baseline (at week 0), Follow Up (after 8 weeks)
Using the PROMIS: 8-item parent report, total score; and the disturbance 8-item parent report, total score; impairment
Time frame: Baseline (at week 0), Follow Up (after 8 weeks), Entire Study (8 weeks)
Using the Pittsburgh Sleep Quality Index (PSQI), 19-item questionnaire: sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, use of sleeping medication, daytime dysfunction, total score; and the Fitbit Inspire 3: Baseline and follow up; sleep duration, sleep efficiency, regulatory of sleep time
Time frame: Baseline (at week 0), Follow Up (after 8 weeks)
Using the Parent Stress Index-Short Form (PSI), 36-item questionnaire: parent distress, parent-child dysfunctional interaction, difficult child; total score
Contact information is provided by the study sponsor or research team.
Boston Children's Hospital
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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