Clinical trial NCT04592172: Impact of Bedtime Routines on Sleep and Development in Toddlers
Official title: Impact of Bedtime Routines on Sleep and Development in Toddlers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Sleep Disturbance
Child Development
Lead sponsor: Saint Joseph's University, Philadelphia
Sponsor class: OTHER
Collaborators: name: Temple University
name: Simms/Mann Family Foundation
name: CuddleBright Cares
name: Johnson & Johnson Consumer Inc. (J&JCI)
First posted: 2020-10-19
Enrollment: 100
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 100 caregiver-infant dyads (infants ages 12.0 to 14.9 months) will be recruited from Temple Pediatric Care Outpatient Pediatric office with follow-up visits at approximately 15 and 24 months of age.
Primary purpose: TREATMENT

Brief summary: Investigators will recruit up to 100 families (children aged 12.0 to 14.9 months and their primary caregivers) at their scheduled 12-month well child care infant visit at Temple Pediatric Care. The purpose of this randomized controlled trial is to examine the impact of implementation of a bedtime routine program, Connect, Calm, \& Comfort: 3 Cs for Bedtime ZZZs, to promote better sleep and improve developmental outcomes in toddlers from primarily low-income families.

Detailed description: A bedtime routine is a key factor in the promotion of not only healthy sleep, but also potentially of broad development and wellbeing in early childhood. A bedtime routine, in and of itself, embodies the characteristics of nurturing care and early child stimulation especially for at-risk children. It is consistent with the Lancet Early Childhood Series Steering Committee emphasizing the need for nurturing care, which includes adequate health, nutrition, security and safety, responsive caregiving, and early learning opportunities, to help young children (ages 0-5 years) reach their full developmental potential, and to build a strong foundation for subsequent development, health, and wellbeing. Common, adaptive components of a bedtime routine can contribute to an array of positive developmental outcomes beyond improved sleep, inclusive of language development, literacy, child emotional and behavioral regulation, parent-child attachment, and family functioning, among other outcomes. Although studies have been conducted on the relationship between bedtime routines and sleep, there have been few studies looking at bedtime routines and other developmental outcomes.

Eligibility criteria: Inclusion Criteria:

* Presenting to a well child visit
* Child between 12.0 to 14.9 months of age
* English-speaking
* Caregiver is legal guardian of infant
* Caregiver is primary caregiver of infant

Exclusion Criteria:

* Non-English speaking
* Absence of primary caregiver at both the 12-month and 15-month well-child visit

Primary outcomes:
measure: Change in sleep outcomes
timeFrame: 15-month and 24-month visits
Secondary outcomes:
measure: Developmental outcomes
timeFrame: 15-month and 24-month visits
measure: Socio-emotional outcomes
timeFrame: 15-month and 24-month visits
measure: Parent stress
timeFrame: 15-month and 24-month visits
measure: Treatment acceptability
timeFrame: 15-month and 24-month visits
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Temple Pediatrics
state: Pennsylvania
Study officials:
affiliation: Temple University
name: Megan Heere, MD
role: PRINCIPAL_INVESTIGATOR
References: