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Testing and Development of a Sleep Training Mobile Health Application

Testing and Development of a Sleep Training Mobile Health Application to Address Sleep Problems in the First Two Years of Life

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02718196
Enrollment
0
Registered
2016-03-24
Start date
2020-07-31
Completion date
2021-01-31
Last updated
2020-11-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep

Brief summary

The specific aims of this study are : 1) To pilot test the alpha build prototype of the sleep training smartphone application using a sample of parents looking for sleep training advice online. 1a) To assess the efficacy of the application in helping parents with the sleep training process 1b) To assess the 'workability' of the application 2) Use feedback to guide the next round of development with the goal of building out the applications functionality and increasing usability.

Detailed description

Problems with bedtime and night-wakings are common in early childhood. Behavioral interventions to address these sleep problems are commonly referred to as sleep training and are effective but difficult for some parents to perform. The investigators have developed a prototype of a novel smartphone application designed to assist parents throughout this process. The smartphone application first collects basic information from the parents, including: first name of child, number of caregivers participating in bedtime, tolerance of caregivers for crying, and basic information about timing of sleep and wake, as well as information about the usual order of events at bedtime. At each step, a brief (2-3 paragraph) is provided to explain the rationale for the next step, as well as concrete advice on how to succeed. It then walks parents through proven techniques to improve sleep in children in a stepwise fashion.

Interventions

BEHAVIORALSleep Training smartphone application

Every evening the application provides a list of the planned bedtime activities as well as the recommended bedtime. The steps are 1) positive bedtime routine 2) bedtime fading 3)addressing nocturnal feeding 4) extinction protocol

Sponsors

Yale University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Months to 24 Months
Healthy volunteers
Yes

Inclusion criteria

* english speaking * parent of child age 6-24 months * target child sleeping in crib in his or her own room (not the same room as the parents or a sibling) * actively looking to sleep train their child * own an iOS or Android smartphone

Exclusion criteria

* bedsharing/cosleeping with child * target child has a known developmental delay * target child has a significant health issue affecting his/her sleep (failure to thrive, congenital heart disease, etc).

Design outcomes

Primary

MeasureTime frameDescription
Change in average number of night wakings by Brief Infant Sleep Questionnaire (BISQ)study entry and 1 monthThe question is: Average number of night wakings per night: \_\_\_\_\_\_\_\_\_\_\_\_ Brief Infant Sleep Questionnaire (BISQ)This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency.
Perception of child's sleep problem- Brief Infant Sleep Questionnaire (BISQ)study entryBrief Infant Sleep Questionnaire (BISQ)This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Do you consider your child's sleep as a problem? □ A very serious problem □ A small problem □ Not a problem at all

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026