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Completed

NCT Number: NCT04592172

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.

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Key information

Conditions

Sleep Child Development Mental Disorders Nervous System Diseases Parasomnias Sleep Disturbance Sleep Wake Disorders

Age range

12 month–15 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Temple Pediatrics

Philadelphia, Pennsylvania, 19140, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bedtime Routine Education

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.

Primary outcomes

  1. Change in sleep outcomes - bedtime routines

    Time frame: 12-month, 15-month, and 24-month visits

    At the 12-month, 15-month, and 24-month visits, caregivers will report on bedtime routine frequency (the number of nights their child followed the same bedtime routine) from the well-validated and widely used Brief Infant Sleep Questionnaire-Revised (Short Form) (BISQ-R).

  2. Sleep outcomes - patterns and problems

    Time frame: 15-month and 24-month visits

    At 15-month and 24-month visits, caregivers will complete the well-validated and widely used Brief Infant Sleep Questionnaire-Revised (Short Form) (BISQ-R) to report on toddler sleep over the last two weeks. 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).

Secondary outcomes

  1. Socio-emotional outcomes

    Time frame: 15-month and 24-month visits

    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.

  2. Parent stress

    Time frame: 15-month and 24-month visits

    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.

  3. Treatment acceptability

    Time frame: 15-month and 24-month visits

    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.

  4. Treatment feasibility

    Time frame: 12-month and 15-month visits

    The study team will track the number of treatment sessions completed (maximum = 2, 1 session at 12-month visit and 1 session at 15-month visit) for caregivers randomized to the bedtime routine education arm.

Sponsors and collaborators

Lead sponsor

Saint Joseph's University, Philadelphia

Other

Collaborators

  • CuddleBright Cares
  • Johnson & Johnson Consumer Inc. (J&JCI)
  • Simms/Mann Family Foundation
  • Temple University

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 19, 2020
Registry last updated
Aug 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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