Actively Recruiting

Phase Not Applicable
All Genders
Healthy Volunteers
ID06248125

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

Led by Yale University · Updated on 2025-05-11

192

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

Y

Yale University

Lead Sponsor

E

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are exploring how enriched parent-infant interactions through music and reading may influence early life physical and mental health. This study focuses on infants aged 0 to 4 months and examines how low-cost, easy-to-use interventions like infant-directed singing, passive music listening, and book reading can support infant mood, sleep quality, and parental well-being. The study is a Phase II randomized trial aiming to understand how these interventions affect families, especially those who are socio-economically disadvantaged or first-time parents. Participants will be randomly assigned to one of four groups: a singing intervention where parents engage in weekly smartphone-based music classes with their infants; a music listening group receiving curated playlists for passive listening; a book reading group provided with interactive reading materials and videos; or a no-intervention control group. The singing intervention involves active engagement with songs and movements, while the other groups focus on either passive music exposure or enriched reading activities, all delivered via smartphone apps over 20 weeks. During the 8-month study, families will participate in text message surveys and complete questionnaires to track infant distress recovery, mood, and sleep quality, along with parent mood, mental health, and parenting confidence. Data will also be collected on family context and parent-infant attachment. Researchers will analyze these health outcomes and engagement levels to assess the effects of each intervention compared to no treatment. The study includes follow-up assessments at weeks 25-26 and 31-32 to monitor lasting impacts.

CONDITIONS

Brief Title

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

Who Can Participate

All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Parent or primary caregiver who cares for the infant at least 50% of the time during a typical week
  • Able to communicate and complete surveys in English
  • Has a smartphone
  • Infant is healthy
Not Eligible

You will not qualify if you...

  • No restrictions based on caregiver age, sex, or other demographic characteristics

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or remote screening)

Outpatient Treatment

Duration - 20 weeks

Participants receive one of four behavioral interventions involving parent-infant interactions: singing, music listening, book reading, or no intervention. These interventions aim to enrich parent-infant interaction through weekly smartphone-based programs with videos, playlists, or books.

Weekly remote engagement via smartphone-based resources

Follow-up

Duration - 6 to 12 weeks after intervention

Participants are assessed for infant mood, parent mood, sleep quality, infant recovery from distress, parenting efficacy, and parent well-being after the intervention period to understand lasting effects.

2 visits (post intervention at weeks 25-26 and follow-up at weeks 31-32)

Trial Site Locations

Total: 1 location

1

Yale Child Study Center

New Haven, Connecticut, United States, 06520

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Research Team

M

Music Lab Lab coordinator

S

Samuel Mehr

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

4

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