Recruitment

Recruitment Status
Enrolling by invitation
Estimated Enrollment
Same as current

Summary

Conditions
  • Child Development
  • Sleep
  • Sleep Disturbance
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: 100 caregiver-infant dyads (infants ages 12.0 to 14.9 months) will be recruited from Temple Pediatric Care Outpatient Pediatric officeMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Younger than 1215 years
Gender
Both males and females

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. I...

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.

Tracking Information

NCT #
NCT04592172
Collaborators
  • Temple University
  • Simms/Mann Family Foundation
  • CuddleBright Cares
  • Johnson & Johnson Consumer Inc. (J&JCI)
Investigators
Principal Investigator: Megan Heere, MD Temple University