Effects of Enriched Parent-Infant Interaction on Health in Early Life (BIGMIPH)

Early life experiences, such as those associated with stable attachment, supportive relationships, and nurturing environments, have profound effects on lifelong physical and mental health. However, children have very different levels of access to such experiences, depending on their family characteristics and associated risk and resilience factors. Low-cost interventions aimed at improving infant environments offer a promising avenue for reducing inequality in early experiences because they require minimal effort to implement. Previous work from the Music lab showed the promise of infant-directed vocalizations, especially music, for enriching parent-infant interaction. Such behaviors are cross-culturally universal, appear regularly in the context of infant care, and have robust effects on infant psychophysiology. In recently completed pilot work, it was found that a brief smartphone-based music intervention achieved high adherence and low attrition; led parents to increase their use of music in soothing their fussy infants; and improved infant mood, as reported via ecological momentary assessment (EMA). Together, these findings show the potential for enriched parent-infant interaction, particularly via infant-directed singing, to improve infant and parent health. Here, a Phase II randomized trial is proposed to explore such effects. Parent/infant dyads (N = 192, infant starting ages 0 to 4 months) will be randomly assigned to one of four conditions: (1) music with enrichment, where parents receive a smartphone-based intervention to learn to sing interactively with their infants, via the early childhood music program Music Together; (2) music with limited enrichment, where parents receive music recordings to listen to with their infants, but are not provided with enrichment activities; (3) enrichment with limited music, where parents receive books to read interactively with their infants, but are not provided with music activities; or (4) a no-treatment control. Throughout the 8-month study, a text-message-based EMA and a survey battery will be used to measure key health outcomes for both infants (distress and recovery, sleep quality, and mood) and parents (mood, mental health status, and parenting efficacy); potential moderators of such effects (demographics, family contextual factors, parent/infant attachment, and infant temperament); as well as parents' degree of engagement in the interventions. Effects will be analyzed both across the intervention groups and relative to the no-treatment control to determine the relative effects of each intervention. The results of this work will determine the effects of low-cost, low-effort early enrichment interventions on basic, everyday health outcomes for infants and parents, test the feasibility of app-based interventions and data collection tools (including in socio-economically disadvantaged families), and provide rich data on the daily lives (including mood, temperament, and sleep variables) of families with young infants. The findings will have particular relevance for underprivileged families and first-time parents, and will set the stage for larger-scale studies of early parent-infant enrichment.

Study Overview

• Status: Recruiting
• Conditions: Parenting Intervention
• Intervention / Treatment: Behavioral: Singing intervention; Behavioral: Music listening intervention; Behavioral: Book reading intervention

• Study Type: Interventional
• Enrollment (Estimated): 192
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Music Lab Lab coordinator; Phone Number: 1-844-362-9272; Email: musiclab@yale.edu
• Study Contact Backup: Name: Samuel Mehr; Phone Number: 1-844-362-9272; Email: sam@yale.edu

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Recruiting
      • Yale Child Study Center
      • Contact: Samuel Mehr; Phone Number: 844-362-9272; Email: sam@yale.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Investigators will recruit parents or primary caregivers:

• who are the infant's primary caregiver at least 50% of the time during a typical week
• who can communicate and complete surveys in English
• who have a smartphone
• whose infants are healthy.

Exclusion Criteria:

• Investigators will not restrict recruitment of caregivers by age, sex, or any other demographic characteristic.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Singing intervention (music with enrichment); The goal of this intervention is to improve the frequency and quality of active parent-infant interaction via infant-directed singing. Throughout the 20-week intervention period, parents will be offered a weekly, smartphone- based, music intervention program featuring video-recorded music classes specifically designed for parents with infants. The video classes, which are part of Music Together Wiggle & Sing curriculum, introduce new songs and demonstrate hands-on activities with the songs that parents can easily incorporate into their daily routines. The activities are highly interactive, emphasizing physical contact, gross-motor play, eye contact, cuddling, and rocking. Recordings of these songs will be also provided to supplement parents' learning in the instructional videos with audio-only content (e.g., for parents to use when viewing a video is not convenient). Parents will use the Music Together app and receive a weekly access code for a fresh set of intervention resources.	Behavioral: Singing intervention; The goal of this intervention is to improve the frequency and quality of active parent-infant interaction via infant-directed singing.
Active Comparator: Music listening intervention (music with limited enrichment); This intervention follows the same structure as the singing intervention but focuses on the use of passive music listening rather than live singing. On a weekly basis, parents will be provided with a carefully curated music playlist, along with tips on how to effectively incorporate recorded music into their daily lives. These weekly playlists will feature 10 music recordings suitable for everyday scenarios commonly experienced together by parents and infants (e.g., calming lullabies for naptime, exciting play songs for free play). The playlists are intended to serve as background music, thus creating a very different musical experience compared to that of the singing intervention. Each week, parents will receive a link to access a new playlist, along with an information sheet about the music and tips on how to use them. Parents will use Spotify to access the playlists on their smartphones and computers.	Behavioral: Music listening intervention; This intervention follows the same structure as the singing intervention but focuses on the use of passive music listening rather than live singing.
Active Comparator: Book reading intervention (enrichment with limited music); This intervention follows the same structure as the singing intervention, but without the musical elements, while emphasizing enriched parent-infant interaction in non-musical (or less-musical) contexts. Throughout the intervention period, parents will be provided with developmentally appropriate books, carefully selected to encourage increased parent interaction. Along with each book, a demonstration video analogous to the Wiggle and Sing videos used in the singing intervention will be offered. These videos demonstrate techniques to create a rich listening experience for young infants, such as using infant-directed speech and highlighting aspects of illustrations to engage the infant. In line with the singing intervention, the activities will be highly interactive, emphasizing the use of infant-directed speech and physical interactions with their infants.	Behavioral: Book reading intervention; This intervention follows the same structure as the singing intervention, but without the musical elements, while emphasizing enriched parent- infant interaction in non-musical (or less-musical) contexts.
No Intervention: No intervention; No intervention will be provided.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infant Mood	Infant mood measured by a pictorial scale from used in pilot work, measured via Ecological Momentary Assessment (EMA) self-report	post intervention (week 25-26)
Infant Mood	Infant mood measured by a pictorial scale from used in pilot work, measured via Ecological Momentary Assessment (EMA) self-report	week 31-32
Parent Mood	Parent mood measured by self-assessed valence, impact, and rationality; from the 3d Mind Model approach to mental state assessment via Ecological Momentary Assessment (EMA) self-report	post intervention (week 25-26)
Parent Mood	Parent mood measured by self-assessed valence, impact, and rationality; from the 3d Mind Model approach to mental state assessment via Ecological Momentary Assessment (EMA) self-report	week 31-32
Sleep quality	Measured by the number of night waking episodes that occurred the previous night, and the estimated duration of each episode assessed using the EMA self-report	post intervention (week 25-26)
Sleep quality	Measured by the number of night waking episodes that occurred the previous night, and the estimated duration of each episode assessed using the EMA self-report	week 31-32
Infant recovery from distress	Measured by the number of crying episodes that occurred within 3 hours of an ecological momentary assessment ping, and if so, the estimated duration of each episode, and the estimated time to recover from each episode via EMA self-report	post intervention (week 25-26)
Infant recovery from distress	Measured by the number of crying episodes that occurred within 3 hours of an ecological momentary assessment ping, and if so, the estimated duration of each episode, and the estimated time to recover from each episode via EMA self-report	week 31-32
Parenting efficacy	Measured by the Karitane Parenting Confidence Scale. It contains 15 items with a possible range of scores of 0-45. Higher scores indicate the parent is feeling more confident.	post intervention (week 25-26)
Parenting efficacy	Measured by the Karitane Parenting Confidence Scale. It contains 15 items with a possible range of scores of 0-45. Higher scores indicate the parent is feeling more confident.	week 31-32

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parent well-being- Edinburgh Postnatal Depression Scale	Measured using the Edinburgh Postnatal Depression Scale. It contains 10 items with total score range of 0-30 with scores 13 and above indicating depressive illness.	post intervention (week 25-26)
Parent well-being- Edinburgh Postnatal Depression Scale	Measured using the Edinburgh Postnatal Depression Scale. It contains 10 items with total score range of 0-30 with scores 13 and above indicating depressive illness.	week 31-32
Parent well-being- Patient Health Questionnaire (PHQ-9)	Measured using the Patient Health Questionnaire. Total score range 0-27. Higher scores indicate lower physical and mental wellbeing.	post intervention (week 25-26)
Parent well-being- Patient Health Questionnaire (PHQ-9)	Measured using the Patient Health Questionnaire. Total score range 0-27. Higher scores indicate lower physical and mental wellbeing.	week 31-32

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Samuel Mehr, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: January 31, 2024
• First Submitted That Met QC Criteria: January 31, 2024
• First Posted (Actual): February 8, 2024

Study Record Updates

• Last Update Posted (Actual): May 11, 2025
• Last Update Submitted That Met QC Criteria: May 6, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2000035858; 1R21HD113998-01 (U.S. NIH Grant/Contract: NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All de-identified data will be shared upon preprinting and/or publication of the results at the Open Science Framework, Zenodo, and other standard scientific data repositories.
• IPD Sharing Time Frame: Available indefinitely from the time of publication and/or the posting of a preprint.
• IPD Sharing Access Criteria: All resources will be open-access.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No