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

Parenting Intervention Clinical Trial

— BIGMIPH  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06248125
• Other study ID #: 2000035858
• Secondary ID: 1R21HD113998-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: June 30, 2026

Study information

• Verified date: January 2024
• Source: Yale University
• Contact: Music Lab Lab coordinator
• Phone: 1-844-362-9272
• Email: musiclab[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 192
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Parenting Intervention

Intervention

Behavioral:
• Singing intervention
The goal of this intervention is to improve the frequency and quality of active parent-infant interaction via infant-directed singing.
• Music listening intervention
This intervention follows the same structure as the singing intervention but focuses on the use of passive music listening rather than live singing.
• Book reading intervention
This intervention follows the same structure as the singing intervention, but without the musical elements, while emphasizing enriched parent- infant interaction in non-musical (or less-musical) contexts.

Locations

Country	Name	City	State
United States	Yale Child Study Center	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infant Mood	Infant mood measured by a pictorial scale from used in pilot work, measured via Ecological Momentary Assessment (EMA) self-report	post intervention (week 25-26)
Primary	Infant Mood	Infant mood measured by a pictorial scale from used in pilot work, measured via Ecological Momentary Assessment (EMA) self-report	week 31-32
Primary	Parent Mood	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	post intervention (week 25-26)
Primary	Parent Mood	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	week 31-32
Primary	Sleep quality	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	post intervention (week 25-26)
Primary	Sleep quality	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	week 31-32
Primary	Infant recovery from distress	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	post intervention (week 25-26)
Primary	Infant recovery from distress	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	week 31-32
Primary	Parenting efficacy	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.	post intervention (week 25-26)
Primary	Parenting efficacy	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.	week 31-32
Secondary	Parent well-being- Edinburgh Postnatal Depression Scale	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.	post intervention (week 25-26)
Secondary	Parent well-being- Edinburgh Postnatal Depression Scale	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.	week 31-32
Secondary	Parent well-being- Patient Health Questionnaire (PHQ-9)	Measured using the Patient Health Questionnaire. Total score range 0-27. Higher scores indicate lower physical and mental wellbeing.	post intervention (week 25-26)
Secondary	Parent well-being- Patient Health Questionnaire (PHQ-9)	Measured using the Patient Health Questionnaire. Total score range 0-27. Higher scores indicate lower physical and mental wellbeing.	week 31-32