Testing and Development of a Sleep Training Mobile Health Application

NCT ID: NCT02718196

Last Updated: 2020-11-23

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-31
• Study Completion Date: 2021-01-31

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.

Conditions

Sleep

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Application Users

English-speaking parents of children ages 6-24 months who are interested in starting sleep training within the next month.

Group Type: EXPERIMENTAL

Sleep Training smartphone application

Intervention Type: 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

Interventions

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

Intervention Type: BEHAVIORAL

Eligibility 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).

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 24 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

1603017350

Identifier Type: -

Identifier Source: org_study_id