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NCT06248125 · ClinicalTrials.gov registry record · NA

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

A NA study of Parenting Intervention, sponsored by Yale University.

Recruiting
Registry status
NA
Development phase
192
Enrollment target
1
Study location

NCT06248125: Recruiting NA study of Parenting Intervention, sponsored by Yale University.

NCT06248125 is a NA study of Parenting Intervention that is actively recruiting participants, run by Yale University. The registered enrollment target is 192 participants, below the 410-participant average among 4 other Parenting Intervention trials with a reported enrollment target (53% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06248125, a NA study of Parenting Intervention, is actively recruiting participants, sponsored by Yale University.

RECRUITING
Registry status
NA
Development phase
192 participants
Enrollment target
1
Study location

Study 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. Thro

Primary Outcome

Infant mood measured by a pictorial scale from used in pilot work, measured via Ecological Momentary Assessment (EMA) self-report

Conditions Studied

Interventions

  • BEHAVIORAL Singing intervention
  • BEHAVIORAL Music listening intervention
  • BEHAVIORAL Book reading intervention

Study Locations (1)

Connecticut

  • Yale Child Study Center - New Haven

Trial Details

FieldValue
Enrollment Target 192 participants
Start Date 2025-02-25
Est. Completion 2026-06-30
Phase NA
Yale University

1,492 total trials

What NCT06248125 shows while recruiting

NCT06248125 is an interventional study that assigns participants to a tested intervention. The registered 192 participants enrollment target is mid-sized for trials with a published cap, below the 410-participant average among 4 other Parenting Intervention trials with a reported enrollment target (53% lower).

The record links to 1 condition, with Parenting Intervention appearing as the primary indexed condition, and to 3 interventions - of which Singing intervention is the first listed.

NCT06248125 reports a single indexed study location in Connecticut.

Frequently Asked Questions

What is clinical trial NCT06248125 about?

NCT06248125 is a clinical study titled "Effects of Enriched Parent-Infant Interaction on Health in Early Life". 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 character...

What is the current status of trial NCT06248125?

This trial is currently recruiting. It is a NA study. The enrollment target is 192 participants. The study started on 2025-02-25. Estimated completion is 2026-06-30.

What conditions does trial NCT06248125 study?

This clinical trial studies the following conditions: Parenting Intervention.

What interventions are being tested in trial NCT06248125?

The interventions under investigation include: Singing intervention (BEHAVIORAL), Music listening intervention (BEHAVIORAL), Book reading intervention (BEHAVIORAL).

Who is sponsoring clinical trial NCT06248125?

This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06248125 being conducted?

This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT06248125, the US trial registry maintained by the National Library of Medicine. NCT06248125 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.