Clinical trial NCT03447665: Infant Behavioral Sleep Intervention: Comparative Efficacy
Official title: Infant Behavioral Sleep Intervention: Comparative Efficacy Across Two Approaches "The Sleeping Baby Study"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Keywords: Infant behavioral sleep intervention
Infant sleep
Pediatric insomnia
Infant night wakings
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Purdue University
name: Saint-Joseph University
First posted: 2018-02-27
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Families are randomly assigned to one of three groups: control, bedtime only (intervention), or all night (intervention).
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Infant has disruptive night wakings (wakes 1x or more/night, 5+ nights per wk; caregiver intervenes at night wakings)
* Infant is placed in bed asleep in a crib/bassinet or similar at bedtime at least five nights per week
* Parent/caregiver goal is for the infant to fall asleep independently at bedtime and/or return to sleep independently during the night
* Parent/caregiver goal is for the infant to sleep in crib or similar
* Parent/caregiver lives in the home with the infant, is typically at home at the time of the infant's typical bedtime at least 5 nights a week, and is primary caregiver at bedtime and during the night.
* The family must have in-home private wireless access that they are willing to share with the study team (necessary for streaming video)
* Families lives in Indianapolis, Indiana or surrounding areas (within 50 miles of Indiana University School of Medicine)

Exclusion Criteria:

* Infant has a chronic major medical condition that affects sleep
* Infant has a major developmental condition (e.g. Down syndrome)
* Family is already receiving professional help for the infant's sleep problems
* Infant snores 5+ nights per week (in which case a sleep study will be recommended; families could participate in the study following a negative sleep study.)
* Infant has chronic skin conditions (e.g. eczema) that would prohibit wearing an actigraph on the leg

Primary outcomes:
measure: Infant sleep (subjective)
timeFrame: Change in score from baseline (day 2, prior to the start of intervention) to post-intervention (day 16)
Secondary outcomes:
measure: Infant sleep (objective): wake after sleep onset
timeFrame: Average per night from nights 1-3 (baseline) compared to average from nights 15-17 (2 weeks later; after intervention)
measure: Infant sleep (subjective): wake after sleep onset
timeFrame: Average per night from nights 1-3 (baseline) compared to average from nights 15-17 (2 weeks later; after intervention)
measure: Infant sleep (objective): longest sleep period
timeFrame: Average per night from nights 1-3 (baseline) compared to average from nights 15-17 (2 weeks later; after intervention)
measure: Infant sleep (subjective): longest sleep period
timeFrame: Average per night from nights 1-3 (baseline) compared to average from nights 15-17 (2 weeks later; after intervention)
measure: Parental stress
timeFrame: Average from nights 1-3 (baseline) compared to average from nights 15-17 (2 weeks later; after intervention)
measure: Parental mood
timeFrame: Baseline (day 2, prior to the start of intervention) compared to post-intervention (day 16)
measure: Parental sleep
timeFrame: Baseline (day 2, prior to the start of intervention) compared to post-intervention (day 16)
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
Study officials:
References: