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

Not Applicable

Recruiting

• Conditions: Parenting Intervention

• Registration Number: NCT06248125
• Lead Sponsor: Yale University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-31
• Study First Submitted QC: 2024-01-31
• Study First Posted: 2024-02-08
• Study Start: 2025-02-25
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-11
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 192

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Sleep quality	week 31-32	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
Infant Mood	week 31-32	Infant mood measured by a pictorial scale from used in pilot work, measured via Ecological Momentary Assessment (EMA) self-report
Infant recovery from distress	week 31-32	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
Parent Mood	week 31-32	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
Parenting efficacy	week 31-32	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.

Secondary Outcome Measures

Name	Time	Method
Parent well-being- Patient Health Questionnaire (PHQ-9)	week 31-32	Measured using the Patient Health Questionnaire. Total score range 0-27. Higher scores indicate lower physical and mental wellbeing.
Parent well-being- Edinburgh Postnatal Depression Scale	week 31-32	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.

Trial Locations

Locations (1)

Yale Child Study Center; 🇺🇸 New Haven, Connecticut, United States