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

NCT06593236 | Active Not Recruiting DMC

• 2 other identifiers: 202427821U54HL143541
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Infant Development; Maternal Behavior

Keywords

Infant Sleep; Maternal Mental Health

Outcome Measures

Primary Outcomes (4)

• Infant sleep quality

  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

  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

  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

  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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• Huckleberry Labs, Inc.: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

UMass Chan Medical School

Worcester, Massachusetts, 01655, United States

Location

Study Officials

• Nisha Fahey, DO

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 9, 2024
• First Posted: September 19, 2024
• Study Start: October 8, 2024
• Primary Completion: August 29, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 14, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)