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Testing and Development of a Sleep Training Mobile Health Application

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ClinicalTrials.gov Identifier: NCT02718196
Recruitment Status : Withdrawn (App stopped development before minimum viable product created)
First Posted : March 24, 2016
Last Update Posted : November 23, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Sleep Behavioral: Sleep Training smartphone application Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Testing and Development of a Sleep Training Mobile Health Application to Address Sleep Problems in the First Two Years of Life
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

Arm Intervention/treatment
Experimental: Application Users
English-speaking parents of children ages 6-24 months who are interested in starting sleep training within the next month.
Behavioral: Sleep 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




Primary Outcome Measures :
  1. Change in average number of night wakings by Brief Infant Sleep Questionnaire (BISQ) [ Time Frame: study entry and 1 month ]

    The 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.


  2. Change in average number of night wakings by Brief Infant Sleep Questionnaire (BISQ) [ Time Frame: 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: ____________

  3. Perception of child's sleep problem- Brief Infant Sleep Questionnaire (BISQ) [ Time Frame: study entry ]

    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?

    □ A very serious problem □ A small problem □ Not a problem at all


  4. Perception of child's sleep problem- Brief Infant Sleep Questionnaire (BISQ) [ Time Frame: 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?



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Ages Eligible for Study:   6 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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).
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02718196    
Other Study ID Numbers: 1603017350
First Posted: March 24, 2016    Key Record Dates
Last Update Posted: November 23, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No