MedPath

Testing and Development of a Sleep Training Mobile Health Application

Not Applicable
Withdrawn
Conditions
Sleep
Interventions
Behavioral: Sleep Training smartphone application
Registration Number
NCT02718196
Lead Sponsor
Yale University
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.

Recruitment & Eligibility

Status
WITHDRAWN
Sex
All
Target Recruitment
Not specified
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
Read More
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).
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Application UsersSleep Training smartphone applicationEnglish-speaking parents of children ages 6-24 months who are interested in starting sleep training within the next month.
Primary Outcome Measures
NameTimeMethod
Perception of child's sleep problem- Brief Infant Sleep Questionnaire (BISQ)3 months

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. The question is: Do you consider your child's sleep as a problem?

Change in average number of night wakings by Brief Infant Sleep Questionnaire (BISQ)study entry and 3 months

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. The question is: Average number of night wakings per night: ____________

Secondary Outcome Measures
NameTimeMethod
© Copyright 2025. All Rights Reserved by MedPath