Infant Behavioral Sleep Intervention: Comparative Efficacy

Insomnia Clinical Trial

Official title: Infant Behavioral Sleep Intervention: Comparative Efficacy Across Two Approaches "The Sleeping Baby Study"

Status Completed

Clinical Trial Summary

While frequent night awakenings in newborns are common and expected, an estimated 20-30% of older infants and toddlers have frequent problematic night wakings requiring parental intervention throughout the night. Standard infant behavioral sleep intervention approaches, which require parental intervention throughout the night, are effective but often difficult for families to implement. The aim of this study is to compare the efficacy of two infant behavioral sleep interventions with a no treatment condition, on infant sleep and family functioning. Healthy infants between the ages of 6 and 18 months with night wakings will be randomized into one of three conditions: Entire night intervention, bedtime only intervention, or no treatment.

Clinical Trial Description

Study Design: Randomized controlled trial (RCT). Approximately thirty participants will be randomized to a control condition or one of two intervention conditions.

Participants: Participants are healthy infants between the ages of 6 and 18 months who wake during the night, and their parents. Parents must be willing to engage in infant behavioral sleep intervention.

Study Procedure: Participant recruitment strategies include direct referrals from community primary care providers (PCP)s, signs posted in medical offices, and social media posts. Participants will be screened and consented via phone. Team members will conduct three home visits with participating families to install videorecording device and actigraphy and take a sleep history (Visit 1); teach families the intervention (Visit 2); and remove monitoring equipment and offer intervention to families in the control condition (Visit 3). Parents will be asked to complete daily sleep logs and three sets of surveys using REDCap.

Intervention: The intervention consists of an infant behavioral sleep protocol. For both intervention conditions an interventionist will collaborate with the family to design a tailored sleep schedule and bedtime routine. The interventionist will then teach the family a behavioral approach, which involves placing the infant in his/her crib awake, and leaving the room. The behavioral approach will be individually tailored for each family (e.g., periodic checks). The two intervention conditions differ in regards to the timing of the intervention. In the all night condition, which represents a standard intervention approach, parents are asked to implement the behavioral protocol at bedtime and at subsequent night wakings. In the bedtime only condition, parents are asked to implement the behavioral protocol at bedtime only, and to soothe their infant back to sleep following night wakings.

Measures: Infant sleep will be assessed via parent-report (sleep diary and validated measure); actigraphy; and videosomnography. Parent sleep, parent mood, and infant mood will be assessed via validated parental-report survey measures.

Collaborators on this study include: AJ Schwichtenberg, Purdue University; Jodi Mindell, Saint Joseph University. ;

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

• NCT number: NCT03447665
• Study type: Interventional
• Source: Indiana University
• Status: Completed
• Phase: N/A
• Start date: February 1, 2018
• Completion date: April 10, 2019