Effects of Enriched Parent-Infant Interaction on Health in Early Life
Public ClinicalTrials.gov record NCT06248125. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT06248125
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 216 participants
Conditions and interventions
Conditions
Interventions
- Singing intervention Behavioral
- Music listening intervention Behavioral
- Book reading intervention Behavioral
Behavioral
Eligibility (public fields only)
- Age range
- Not listed
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 24, 2025
- Primary completion
- May 31, 2026
- Completion
- May 31, 2026
- Last update posted
- Jun 21, 2026
2025 – 2026
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Yale Child Study Center | New Haven | Connecticut | 06520 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06248125, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 21, 2026 · Synced Sep 5, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06248125 live on ClinicalTrials.gov.