Impact of Bedtime Routines on Sleep and Development in Toddlers

NCT04592172 | Completed

• 1 other identifier: 2020-02
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep; Sleep Disturbance; Child Development

Outcome Measures

Primary Outcomes (2)

• Change in sleep outcomes - bedtime routines

  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).

  12-month, 15-month, and 24-month visits

• Sleep outcomes - patterns and problems

  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).

  15-month and 24-month visits

Secondary Outcomes (4)

• Socio-emotional outcomes

  15-month and 24-month visits

• Parent stress

  15-month and 24-month visits

• Treatment acceptability

  15-month and 24-month visits

• Treatment feasibility

  12-month and 15-month visits

Study Arms (2)

Bedtime Routine Education

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

Interventions

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.

Bedtime Routine Education

Eligibility Criteria

• Age: 12 Months - 15 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Non-English speaking
• Absence of primary caregiver at both the 12-month and 15-month well-child visit

Sponsors & Collaborators

• Saint Joseph's University, Philadelphia: lead
• Temple University: collaborator
• Simms/Mann Family Foundation: collaborator
• CuddleBright Cares: collaborator
• Johnson & Johnson Consumer Inc. (J&JCI): collaborator

Study Sites (1)

Temple Pediatrics

Philadelphia, Pennsylvania, 19140, United States

Location

MeSH Terms

Conditions

Parasomnias

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Megan Heere, MD

  Temple University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 100 caregiver-infant dyads (infants ages 12.0 to 14.9 months) will be recruited from Temple Pediatric Care Outpatient Pediatric office with follow-up visits at approximately 15 and 24 months of age.

Study Record Dates

• First Submitted: September 4, 2020
• First Posted: October 19, 2020
• Study Start: November 20, 2020
• Primary Completion: November 4, 2022
• Study Completion: November 4, 2022
• Last Updated: August 13, 2025

Record last verified: 2022-11

Locations

US (1)