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

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

RECRUITING

Clinical Phase

NA

Total Enrollment

192 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-25

Study Completion Date

2026-06-30

Brief Summary

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

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy of Family Programs for Improving Child and Family Health and Development

NCT03367845

Behavior, Infant

ACTIVE_NOT_RECRUITING NA

The Effects on Children and Parents of Educating Parents About Ways to Play With Babies

NCT05259423

Infant Development Developmental Delay

COMPLETED NA

Parent-child Interactions, Child Developmental Health, and Health System Costs at 6 Months Corrected Age

NCT03357458

Preterm Birth Prematurity Infant,Premature +4 more

COMPLETED NA

The Healthy Child Development Program Study

NCT04622969

Child Behavior Child Health Child, Preschool +1 more

COMPLETED NA

Purposeful Parenting: Enhanced Anticipatory Guidance for the First Year of Life

NCT02428465

Parenting

COMPLETED NA

Detailed Description

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

Conditions

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

Parenting Intervention

Study Design

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

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Singing intervention

Intervention Type BEHAVIORAL

The goal of this intervention is to improve the frequency and quality of active parent-infant interaction via infant-directed singing.

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.

Group Type ACTIVE_COMPARATOR

Music listening intervention

Intervention Type BEHAVIORAL

This intervention follows the same structure as the singing intervention but focuses on the use of passive music listening rather than live singing.

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.

Group Type ACTIVE_COMPARATOR

Book reading intervention

Intervention Type BEHAVIORAL

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 will be provided.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Singing intervention

The goal of this intervention is to improve the frequency and quality of active parent-infant interaction via infant-directed singing.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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

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.