Parenting InterventionBIGMIPHNCT06248125
Effects of Enriched Parent-Infant Interaction on Health in Early Life
A study testing Singing intervention, Music listening intervention and Book reading intervention in people with Parenting Intervention, run by Yale University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Parenting Intervention
- What is being tested?
- Singing intervention, Music listening intervention and Book reading intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Feb 2025to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Investigators will not restrict recruitment of caregivers by age, sex, or any other demographic characteristic.
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale Child Study Center
New Haven, Connecticut, 06520
About this study
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.
- Conditions
- Parenting Intervention
- Being tested
- Singing intervention, Music listening intervention, Book reading intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Singing interventionBehavioural
The goal of this intervention is to improve the frequency and quality of active parent-infant interaction via infant-directed singing.
Music listening interventionBehavioural
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 interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Singing intervention (music with enrichment) | Experimental | The goal of this intervention is to improve the frequency and quality of active parent-infant interaction via infant-directed singing. Throughout the 20-week intervention period, parents will be offered a weekly, smartphone- based, music intervention program featuring video-recorded music classes specifically designed for parents with infants. The video classes, which are part of Music Together Wiggle \& Sing curriculum, introduce new songs and demonstrate hands-on activities with the songs that parents can easily incorporate into their daily routines. The activities are highly interactive, emphasizing physical contact, gross-motor play, eye contact, cuddling, and rocking. Recordings of these songs will be also provided to supplement parents' learning in the instructional videos with audio-only content (e.g., for parents to use when viewing a video is not convenient). Parents will use the Music Together app and receive a weekly access code for a fresh set of intervention resources. Receives: Behavioral: Singing intervention |
| Music listening intervention (music with limited enrichment) | Active comparator | This intervention follows the same structure as the singing intervention but focuses on the use of passive music listening rather than live singing. On a weekly basis, parents will be provided with a carefully curated music playlist, along with tips on how to effectively incorporate recorded music into their daily lives. These weekly playlists will feature 10 music recordings suitable for everyday scenarios commonly experienced together by parents and infants (e.g., calming lullabies for naptime, exciting play songs for free play). The playlists are intended to serve as background music, thus creating a very different musical experience compared to that of the singing intervention. Each week, parents will receive a link to access a new playlist, along with an information sheet about the music and tips on how to use them. Parents will use Spotify to access the playlists on their smartphones and computers. Receives: Behavioral: Music listening intervention |
| Book reading intervention (enrichment with limited music) | Active comparator | 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. Throughout the intervention period, parents will be provided with developmentally appropriate books, carefully selected to encourage increased parent interaction. Along with each book, a demonstration video analogous to the Wiggle and Sing videos used in the singing intervention will be offered. These videos demonstrate techniques to create a rich listening experience for young infants, such as using infant-directed speech and highlighting aspects of illustrations to engage the infant. In line with the singing intervention, the activities will be highly interactive, emphasizing the use of infant-directed speech and physical interactions with their infants. Receives: Behavioral: Book reading intervention |
| No intervention | No intervention | No intervention will be provided. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infant Mood
Infant mood measured by a pictorial scale from used in pilot work, measured via Ecological Momentary Assessment (EMA) self-report
Measured: post intervention (week 25-26)
Infant Mood
Infant mood measured by a pictorial scale from used in pilot work, measured via Ecological Momentary Assessment (EMA) self-report
Measured: week 31-32
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
Measured: post intervention (week 25-26)
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
Measured: week 31-32
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
Measured: post intervention (week 25-26)
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
Measured: week 31-32
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
Measured: post intervention (week 25-26)
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
Measured: week 31-32
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.
Measured: post intervention (week 25-26)
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.
Measured: week 31-32
Secondary outcomes (4)
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.
Measured: post intervention (week 25-26)
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.
Measured: week 31-32
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.
Measured: post intervention (week 25-26)
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.
Measured: week 31-32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start25 Feb 2025
- Primary completion1 Jun 2026
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parenting InterventionStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Samuel Mehr, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06248125
- Sponsor's protocol ID
- 2000035858
- Other IDs
- 1R21HD113998-01
- Acronym
- BIGMIPH
- Status last verified
- Jun 2026
- First submitted
- 31 Jan 2024
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All de-identified data will be shared upon preprinting and/or publication of the results at the Open Science Framework, Zenodo, and other standard scientific data repositories.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Enriched Parent-Infant Interaction on Health in Early Life
- ClinicalTrials.gov ID
- NCT06248125
- Acronym / sponsor ID
- BIGMIPH / 2000035858
- Conditions
- Parenting Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 25 Feb 2025 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 8 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Singing intervention (music with enrichment) | Experimental | Behavioral: Singing interventionThe goal of this intervention is to improve the frequency and quality of active parent-infant interaction via infant-directed singing. Throughout the 20-week intervention period, parents will be offered a weekly, smartphone- based, music intervention program featuring video-recorded music classes specifically designed for parents with infants. The video classes, which are part of Music Together Wiggle \& Sing curriculum, introduce new songs and demonstrate hands-on activities with the songs that parents can easily incorporate into their daily routines. The activities are highly interactive, emphasizing physical contact, gross-motor play, eye contact, cuddling, and rocking. Recordings of these songs will be also provided to supplement parents' learning in the instructional videos with audio-only content (e.g., for parents to use when viewing a video is not convenient). Parents will use the Music Together app and receive a weekly access code for a fresh set of intervention resources. |
| Music listening intervention (music with limited enrichment) | Active comparator | Behavioral: Music listening interventionThis intervention follows the same structure as the singing intervention but focuses on the use of passive music listening rather than live singing. On a weekly basis, parents will be provided with a carefully curated music playlist, along with tips on how to effectively incorporate recorded music into their daily lives. These weekly playlists will feature 10 music recordings suitable for everyday scenarios commonly experienced together by parents and infants (e.g., calming lullabies for naptime, exciting play songs for free play). The playlists are intended to serve as background music, thus creating a very different musical experience compared to that of the singing intervention. Each week, parents will receive a link to access a new playlist, along with an information sheet about the music and tips on how to use them. Parents will use Spotify to access the playlists on their smartphones and computers. |
| Book reading intervention (enrichment with limited music) | Active comparator | Behavioral: Book reading interventionThis 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. Throughout the intervention period, parents will be provided with developmentally appropriate books, carefully selected to encourage increased parent interaction. Along with each book, a demonstration video analogous to the Wiggle and Sing videos used in the singing intervention will be offered. These videos demonstrate techniques to create a rich listening experience for young infants, such as using infant-directed speech and highlighting aspects of illustrations to engage the infant. In line with the singing intervention, the activities will be highly interactive, emphasizing the use of infant-directed speech and physical interactions with their infants. |
| No intervention | No intervention | –No intervention will be provided. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- Investigators will not restrict recruitment of caregivers by age, sex, or any other demographic characteristic.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Singing interventionThe goal of this intervention is to improve the frequency and quality of active parent-infant interaction via infant-directed singing. | Behavioural | Singing intervention (music with enrichment) |
| Music listening interventionThis intervention follows the same structure as the singing intervention but focuses on the use of passive music listening rather than live singing. | Behavioural | Music listening intervention (music with limited enrichment) |
| Book reading interventionThis 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. | Behavioural | Book reading intervention (enrichment with limited music) |
Primary outcome
Infant Mood
Time frame: post intervention (week 25-26)
Infant mood measured by a pictorial scale from used in pilot work, measured via Ecological Momentary Assessment (EMA) self-report
Infant Mood
Time frame: week 31-32
Infant mood measured by a pictorial scale from used in pilot work, measured via Ecological Momentary Assessment (EMA) self-report
Parent Mood
Time frame: post intervention (week 25-26)
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
Parent Mood
Time frame: week 31-32
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
Sleep quality
Time frame: post intervention (week 25-26)
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
Sleep quality
Time frame: week 31-32
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
Infant recovery from distress
Time frame: post intervention (week 25-26)
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
Infant recovery from distress
Time frame: week 31-32
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
Parenting efficacy
Time frame: post intervention (week 25-26)
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.
Parenting efficacy
Time frame: week 31-32
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.
4 secondary outcomes
Parent well-being- Edinburgh Postnatal Depression Scale
Time frame: post intervention (week 25-26)
Parent well-being- Edinburgh Postnatal Depression Scale
Time frame: week 31-32
Parent well-being- Patient Health Questionnaire (PHQ-9)
Time frame: post intervention (week 25-26)
Parent well-being- Patient Health Questionnaire (PHQ-9)
Time frame: week 31-32
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: Yes. All de-identified data will be shared upon preprinting and/or publication of the results at the Open Science Framework, Zenodo, and other standard scientific data repositories.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel Mehr principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Singing intervention, Music listening intervention and Book reading intervention in people with Parenting Intervention, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infant Mood (time frame: post intervention (week 25-26)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.