Impact of Bedtime Routines on Sleep and Development in Toddlers

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.

Study Overview

• Status: Completed
• Conditions: Sleep; Sleep Disturbance; Child Development
• Intervention / Treatment: Behavioral: Bedtime Routine Education

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple Pediatrics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
No Intervention: Control group; 50 families will be randomly assigned to control group (usual care).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in sleep outcomes	Caregivers will report on their toddlers sleep in the previous 2 weeks at baseline (12 months of age) and at 15-months and 24-months, using the well-validated and widely used Brief Infant Sleep Questionnaire-Revised (Short Form) (BISQ-R). The BISQ-R contains items related to the child sleep environment (e.g., sleep space, location, and arrangement) and patterns (e.g., bedtime, sleep onset latency, night awakening frequency and duration, wake time). Items also assess caregiver-perceived child sleep problems (e.g., overall sleep problem severity, bedtime resistance severity). The BISQ-R has 3 subscales, Infant Sleep, Parent Behavior, and Parent Perception. Scores range from 0-100, with higher scores denoting better sleep.	15-month and 24-month visits

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Developmental outcomes	The Ages & Stages Questionnaires (ASQ) is an age-specific, reliable and well-validated measure to predict developmental outcomes. Caregivers will report on their infant/child's communication and personal-social skills. Each domain consists of 6 questions and each question is scored with 10 points for "yes," 5 for "sometimes," and 0 for "no," yielding scores ranging from 0 to 60 for each domain. Lower scores denote potential developmental concerns.	15-month and 24-month visits
Socio-emotional outcomes	The Brief Infant-Toddler Social and Emotional Assessment (BITSEA) is a screener derived from the longer ITSEA. It is a parent questionnaire that assesses the social-emotional development of children ranging in age from 12 to 36 months. Caregivers will rate each statement that best describes the child's behavior in the past month, with scores ranging from 0 to 84. Higher scores denote possible social-emotional/ behavioral concerns.	15-month and 24-month visits
Parent stress	The Parenting Stress Index (PSI) Short form is a 36-items reliable measure to assess total parenting stress with high internal consistency. It consists of three subscales: parental distress, parent-child dysfunctional interaction, and difficult child. Statements on this measure are rated on a 5-point Likert scale from strongly agree to strongly disagree, with scores ranging from 36 to 180. Higher scores denote higher level of stress in parent-child relationship.	15-month and 24-month visits
Treatment acceptability	Caregivers randomized to the bedtime routine education arm will complete the treatment acceptability/bedtime routine evaluation form. Caregivers will rate 7 statements related to the perceived helpfulness/efficacy and acceptability of the intervention using a 5-point Likert scale from strongly disagree to strongly agree, with total scores ranging from 0 to 35. Higher scores indicate higher perceived helpfulness and acceptability of the intervention.	15-month and 24-month visits

Collaborators and Investigators

• Sponsor: Saint Joseph's University, Philadelphia
• Collaborators: Johnson & Johnson Consumer Inc. (J&JCI); Temple University; Simms/Mann Family Foundation; CuddleBright Cares
• Investigators: Principal Investigator: Megan Heere, MD, Temple University

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2020
• Primary Completion (Actual): November 4, 2022
• Study Completion (Actual): November 4, 2022

Study Registration Dates

• First Submitted: September 4, 2020
• First Submitted That Met QC Criteria: October 16, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Actual): November 9, 2022
• Last Update Submitted That Met QC Criteria: November 7, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Wake Disorders; Dyssomnias; Parasomnias
• Other Study ID Numbers: 2020-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No