Testing and Development of a Sleep Training Mobile Health Application

NCT02718196 | Withdrawn

• 1 other identifier: 1603017350
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sleep

Outcome Measures

Primary Outcomes (4)

• Change in average number of night wakings by Brief Infant Sleep Questionnaire (BISQ)

  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.

  study entry and 1 month

• Change in average number of night wakings by Brief Infant Sleep Questionnaire (BISQ)

  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: \_\_\_\_\_\_\_\_\_\_\_\_

  study entry and 3 months

• Perception of child's sleep problem- Brief Infant Sleep Questionnaire (BISQ)

  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

  study entry

• Perception of child's sleep problem- Brief Infant Sleep Questionnaire (BISQ)

  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?

  3 months

Study Arms (1)

Application Users

EXPERIMENTAL

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

Interventions

Sleep Training smartphone application BEHAVIORAL

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

Application Users

Eligibility Criteria

• Age: 6 Months - 24 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Yale University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2016
• First Posted: March 24, 2016
• Study Start: July 1, 2020
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: November 23, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share