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

November 12, 2025 updated by: Nisha Fahey, University of Massachusetts, Worcester
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.

Study Overview

Status

Active, not recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • UMass Chan Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants will receive healthcare in the UMass Memorial Health System and must be a part of the Medicaid Accountable Care Organizations (ACO). Participants will be a birthing parent of a child aged 0-12 months.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infant sleep quality
Time Frame: 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.
Baseline and 3 months
Maternal mental health
Time Frame: 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.
Baseline and 3 months
Maternal bonding assessment
Time Frame: 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.
Baseline and 3 months
Infant and parent sleep practices
Time Frame: 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.
Baseline and 3 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Massachusetts, Worcester

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)
Huckleberry Labs, Inc.

Investigators

  • Principal Investigator: Nisha Fahey, DO, Assistant Professor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 8, 2024

Primary Completion (Actual)

August 29, 2025

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

September 9, 2024

First Submitted That Met QC Criteria

September 9, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Estimated)

November 14, 2025

Last Update Submitted That Met QC Criteria

November 12, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 20242782
  • 1U54HL143541 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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