Clinical trial NCT06248125: Effects of Enriched Parent-Infant Interaction on Health in Early Life
Official title: Effects of Enriched Parent-Infant Interaction on Health in Early Life
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parenting Intervention
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2024-02-08
Enrollment: 192
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Infant Mood
timeFrame: post intervention (week 25-26)
measure: Infant Mood
timeFrame: week 31-32
measure: Parent Mood
timeFrame: post intervention (week 25-26)
measure: Parent Mood
timeFrame: week 31-32
measure: Sleep quality
timeFrame: post intervention (week 25-26)
measure: Sleep quality
timeFrame: week 31-32
measure: Infant recovery from distress
timeFrame: post intervention (week 25-26)
measure: Infant recovery from distress
timeFrame: week 31-32
measure: Parenting efficacy
timeFrame: post intervention (week 25-26)
measure: Parenting efficacy
timeFrame: week 31-32
Secondary outcomes:
measure: Parent well-being- Edinburgh Postnatal Depression Scale
timeFrame: post intervention (week 25-26)
measure: Parent well-being- Edinburgh Postnatal Depression Scale
timeFrame: week 31-32
measure: Parent well-being- Patient Health Questionnaire (PHQ-9)
timeFrame: post intervention (week 25-26)
measure: Parent well-being- Patient Health Questionnaire (PHQ-9)
timeFrame: week 31-32
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Child Study Center
state: Connecticut
Study officials:
affiliation: Yale University
name: Samuel Mehr
role: PRINCIPAL_INVESTIGATOR
References: