Impact of Bedtime Routines on Sleep and Development in Toddlers

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.

Conditions

• Sleep
• Sleep Disturbance
• Child Development

Interventions

BEHAVIORAL

Bedtime Routine Education

The intervention aims to promote healthy sleep and improved developmental outcomes in infants. Individualized bedtime routine education, including such activities as a bath, teeth-brushing, reading stories, singing songs, and cuddling will be implemented by research assistants at the 12-month well-child visit. Reinforcement of the bedtime routine education will be implemented at the 15-month visit. Each individualized bedtime routine will incorporate 3-5 steps and a bedtime routine chart depicting those steps will be created and provided to the families. Families will receive materials for their bedtime routines, including a CuddleBright kit, 1-2 additional bedtime books, toothbrush/toothpaste , and the created bedtime chart. On top of that, families will also receive a children's book provided by Reach Out and Read through the study period.

Sponsors & Collaborators

• Temple University

  collaborator OTHER

• Simms/Mann Family Foundation

  collaborator UNKNOWN

• CuddleBright Cares

  collaborator UNKNOWN

• Johnson & Johnson Consumer Inc. (J&JCI)

  collaborator INDUSTRY

• Saint Joseph's University, Philadelphia

  lead OTHER

Principal Investigators

• Megan Heere, MD · Temple University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

12 Months

Max Age

15 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-11-20

Primary Completion

2022-11-04

Completion

2022-11-04

Countries

• United States

Study Locations