Impact of Bedtime Routines on Sleep and Development in Toddlers

Saint Joseph's University, Philadelphia

Status: Completed

Conditions: Child Development; Sleep Disturbance; Sleep

Treatments: Behavioral: Bedtime Routine Education

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04592172

2020-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 12 to 15 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Bedtime Routine Education

Experimental group

Description:

50 families will be randomly assigned to receive the bedtime routine intervention, 3 Cs for Bedtime ZZZs delivered by research assistants at the 12-month and 15-month well-child visits, in additional to receiving usual clinical care. The intervention will take approximately 30-45 minutes to implement at each study visit. Research assistants will be trained and supervised by board-certified Behavioral Sleep Medicine providers. This intervention focuses on developing an individualized bedtime routine, including such activities as a bath, teeth-brushing, reading stories, singing songs, and cuddling, based on parent's preferences. Families will receive appropriate materials for their bedtime routine, including a CuddleBright kit, bedtime books, toothbrush/toothpaste, and the created bedtime chart to take home.

Treatment:

Behavioral: Bedtime Routine Education

Control group

No Intervention group

Description:

50 families will be randomly assigned to control group (usual care).