Impact of Bedtime Routines on Sleep and Development in Toddlers

NCT ID: NCT04592172

Last Updated: 2025-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-20
• Study Completion Date: 2022-11-04

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.

Conditions

Sleep; Sleep Disturbance; Child Development

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bedtime Routine Education

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.

Group Type: EXPERIMENTAL

Bedtime Routine Education

Intervention Type: BEHAVIORAL

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.

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 15 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Temple University

OTHER

Sponsor Role: collaborator

Simms/Mann Family Foundation

UNKNOWN

Sponsor Role: collaborator

CuddleBright Cares

UNKNOWN

Sponsor Role: collaborator

Johnson & Johnson Consumer Inc. (J&JCI)

INDUSTRY

Sponsor Role: collaborator

Saint Joseph's University, Philadelphia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Megan Heere, MD

Role: PRINCIPAL_INVESTIGATOR

Temple University

Locations

Temple Pediatrics

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

2020-02

Identifier Type: -

Identifier Source: org_study_id