Impact of Bedtime Routines on Sleep and Development in Toddlers

Completed · Not applicable

Conditions studied: Sleep, Sleep Disturbance, Child Development

In brief

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.

Key facts

Study ID

NCT04592172

Run by

Saint Joseph's University, Philadelphia

People needed

100

Starts

2020-11-20

Expected to finish

2022-11-04

Last updated by the study team

2025-08-13

Who can join

Age: 1 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Temple Pediatrics — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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