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NCT Number: NCT06593236

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Infant Development Maternal Behavior

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

UMass Chan Medical School

Worcester, Massachusetts, 01655, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Collaborators

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

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
Nov 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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