Bedtime Stories: Tailored Sleep Health Messaging for Caregivers
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBoston Children's Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Planning on moving within the next 3 months
Does not live in the home with the child
Trial design
Design model
Single group
Treatments tested in this trial
Bedtime Stories Sleep Health Education Program for Caregivers (BTS-C)
BehavioralThe 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.
Treatment groups
75 Participants
are divided into 1 treatment groupGroup A: Sleep Health Education Program for CaregiversExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Knowledge, Perceptions, and Practices
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 weeks2
Feasibility, acceptability, and usability
Using the Brief Feedback questionnaire (BFQ), 15-item questionnaire; total score
Time frame
Follow Up, after 8 weeks3
Assessment of Child Sleep
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
1 week baseline, 1 week follow up, entire study4
Child Sleep Health
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), Follow Up (after 8 weeks)Secondary outcomes
1
Child Sleep Environment
Using the Children's Adolescents' Sleep Environment Scale (CASES): 13-item parent report; total score
Time frame
Baseline (at week 0)2
Child Sleep Disturbance Impairments
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)3
Assessment of parent/caregiver sleep
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), Entire Study (8 weeks)4
Caregiver Stress
Using the Parent Stress Index-Short Form (PSI), 36-item questionnaire: parent distress, parent-child dysfunctional interaction, difficult child; total score
Time frame
Baseline (at week 0), Follow Up (after 8 weeks)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov