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

NCT ID: NCT06593236

Last Updated: 2025-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-08

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Infant Development Maternal Behavior

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Infant Sleep Maternal Mental Health

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Huckleberry Labs, Inc.

UNKNOWN

Sponsor Role collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

University of Massachusetts, Worcester

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Nisha Fahey

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Nisha Fahey, DO

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

UMass Chan Medical School

Worcester, Massachusetts, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1U54HL143541

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20242782

Identifier Type: -

Identifier Source: org_study_id