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

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clinicaltrials.gov/study/NCT06248125
Is a
‌
Clinical study
0

Clinical Study attributes

NCT Number
NCT062481250
Trial Recruitment Size
1920
Trial Sponsor
Yale University
Yale University
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Clinical Trial Start Date
July 1, 2024
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Primary Completion Date
June 30, 2026
0
Study Completion Date
June 30, 2026
0
Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Basic Science0
Intervention Type
Behavioral0
Interventional Trial Phase
Not Applicable0
Participating Facility
‌
Yale Child Study Center
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Official Name
Effects of Enriched Parent-Infant Interaction on Health in Early Life0
Last Updated
February 8, 2024
0
Allocation Type
Randomized0
Intervention Model
Parallel Assignment0
Masking Type
Double0
Masked Party
Outcomes Assessor0
Participant0

Other attributes

Intervention Treatment
Music listening intervention0
Singing intervention0
Book reading intervention0
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. 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.

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