Association of Digital Aid Use With Infant Sleep and Maternal Mental Health

Recruiting

• Conditions: Infant Development; Maternal Behavior

• Registration Number: NCT06593236
• Lead Sponsor: University of Massachusetts, Worcester

Brief Summary

The goal of this study is to better understand the use of the Huckleberry app, a pediatric sleep guidance app and the impacts on infant sleep and maternal mental health.

Detailed Description

This study aims to understand the impact of the Huckleberry app, a scalable low-cost solution to problematic child sleep patterns, on pediatric sleep and maternal mental health, especially in the Medicaid population.

A secondary aim for this study is to determine if Medicaid Accountable Care Organizations (ACO) goals are improved according to stakeholder interviews.

Study Timeline

• Study First Submitted: 2024-09-09
• Study First Submitted QC: 2024-09-09
• Study First Posted: 2024-09-19
• Status Verified: 2024-10
• Study Start: 2024-10-08
• Last Update Submitted: 2024-10-24
• Last Update Posted: 2024-10-26
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

• Is at least 18 years old
• Has a child between the age of 0-12 months
• Receives healthcare through UMass Memorial Health
• Is a part of the Medicaid Accountable Care Organizations (ACO) population

Exclusion Criteria

• Lacks capacity to consent
• Does not understand English
• Does not have internet access on their smartphone or at home
• If the infant is in Department of Children and Families (DCF) custody or is admitted into the Neonatal Intensive Care Unit (NICU)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Infant sleep quality	Baseline and 3 months	Infant sleep quality will be assessed using the Brief Infant Sleep Questionnaire (BISQ) and will measure the quality and frequency of infant sleep. The BISQ will be delivered to participants at the baseline and endpoint of enrollment.
Maternal mental health	Baseline and 3 months	Maternal mental health will be assessed using the Depression, Anxiety \& Stress Scale (DASS21) and will assess maternal mental health. The DASS21 will be delivered to participants at the baseline and endpoint of enrollment.
Maternal bonding assessment	Baseline and 3 months	Maternal bonding will be assessed using the Postpartum Bonding Assessment (PBQ) and will measure maternal-infant bonding. The PBQ will be delivered to participants at baseline and endpoint of enrollment.
Infant and parent sleep practices	Baseline and 3 months.	Infant and parent sleep practices will be assessed using the Infant Sleep Practices Questionnaire. This will be a tool in assessing sleep practices. This questionnaire will be delivered to participants at baseline and endpoint of enrollment.

Trial Locations

Locations (1)

UMass Chan Medical School; 🇺🇸 Worcester, Massachusetts, United States