Parent-Infant Interaction for Parenting Intervention

(BIGMIPH Trial)

Overseen By Music Lab Lab coordinator

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Disqualifiers: Non-English speakers, No smartphone, Unhealthy infants

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

192 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different types of parent-infant interactions, such as the Enriched Parent-Infant Interaction, can improve health outcomes for both babies and their parents. It examines whether activities like singing, listening to music, or reading can positively affect infant mood, sleep, and parent mental health. The trial includes four groups: singing with music activities, music listening, reading with limited music, and no intervention. Parents who are the main caregivers of healthy babies, have smartphones, and can complete surveys in English may be suitable for this trial. As an unphased trial, this study offers a unique opportunity to contribute to understanding how everyday activities can enhance family well-being.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on parent-infant interactions and does not mention medication requirements.

Is there any evidence suggesting that this trial's interventions are likely to be safe?

Research has shown that singing to infants can improve emotional health. Studies have found that singing lifts an infant's mood and encourages positive interactions between parents and children. No harmful effects were reported, indicating it is well-tolerated.

For the music listening intervention, evidence also points to positive results. Music programs help infants develop self-control skills without any negative effects, suggesting the intervention is safe.

Lastly, the book reading intervention has shown promise in supporting early skills in infants. It helps build a strong foundation for development and has no reported adverse effects, indicating it is a safe and beneficial activity for parents and infants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Parent-Infant Interaction for Parenting Intervention because it explores diverse methods to enhance parent-infant bonding and early development. Unlike traditional parenting programs or interventions that may focus solely on educational content, this trial uniquely incorporates enriched activities like music and book reading to foster interaction. The singing intervention, for example, actively engages parents and infants in music-based activities, enhancing physical contact and communication. Meanwhile, the music listening and book reading interventions provide structured yet flexible approaches to integrate enriching experiences into daily routines. These innovative techniques aim to improve the quality of parent-infant interactions, potentially leading to better developmental outcomes for infants.

What evidence suggests that this trial's interventions could be effective for improving parent-infant interaction?

This trial will compare different interventions to enhance parent-infant interaction. Research has shown that music positively affects babies' moods and their interactions with parents. In this trial, some participants will engage in a singing intervention. Studies have found that when parents sing to their babies, it can make the babies happier and improve their connection with their parents. Another group will participate in a music listening intervention, which also offers similar benefits, enhancing parent-baby interactions. Additionally, a book reading intervention will be tested, as studies have shown it can strengthen parent-baby bonds by encouraging shared time. Overall, these activities suggest that both music and reading can improve early interactions between parents and babies and make babies happier. ^{1 2 6 7 8}

Who Is on the Research Team?

Samuel Mehr

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for parent-infant pairs, with infants aged 0 to 4 months. It's especially relevant for first-time parents and underprivileged families. Participants should be willing to engage in activities like singing, music listening, or book reading with their infant and use an app for intervention guidance.

Inclusion Criteria

I am the main caregiver for my infant at least half of the week.

Investigators will recruit parents or primary caregivers whose infants are healthy.

I am a parent or caregiver who speaks and understands English well.

Exclusion Criteria

My caregiver can be of any age, sex, or background.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Parents and infants participate in one of four conditions: music with enrichment, music with limited enrichment, enrichment with limited music, or no-treatment control. The intervention includes smartphone-based music programs, music playlists, or book reading activities.

20 weeks

Post-intervention Assessment

Assessment of primary and secondary outcomes such as parenting efficacy, infant mood, and sleep quality using various scales and ecological momentary assessment.

6 weeks

Follow-up

Participants are monitored for long-term effects on health outcomes for both infants and parents.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Enriched Parent-Infant Interaction

Trial Overview

The study tests how different low-effort enrichment activities affect the health of both infants and parents. Parents are randomly placed into one of four groups: interactive singing, passive music listening, interactive book reading, or no treatment control group.

How Is the Trial Designed?

Group I: Singing intervention (music with enrichment) Experimental Treatment 1 Intervention

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.

Group II: No intervention Active Control 1 Intervention

No intervention will be provided.

Group III: Music listening intervention (music with limited enrichment) Active Control 1 Intervention

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.

Group IV: Book reading intervention (enrichment with limited music) Active Control 1 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. 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.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

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

Collaborator

Trials

2,103

Recruited

2,760,000+

Published Research Related to This Trial

A meta-analysis of 24 studies showed that both Parent-Child Interaction Therapy (PCIT) and Triple P-Positive Parenting Program effectively reduce child behavior and parenting problems, with PCIT demonstrating large effect sizes in parent-reported outcomes.

PCIT and an enhanced version of Triple P were particularly effective in improving observed child behaviors, suggesting that the choice of intervention may depend on specific goals and contexts in parenting support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral outcomes of Parent-Child Interaction Therapy and Triple P-Positive Parenting Program: a review and meta-analysis. Thomas, R., Zimmer-Gembeck, MJ.[2022]

Clinicians trained using the Cascading Model (CM) were more likely to complete their training and reported higher satisfaction and better learning experiences compared to those in other training models.

Supervisors in the Learning Collaborative (LC) condition reported greater knowledge and satisfaction, while Distance Education (DE) produced comparable results in terms of treatment implementation and clinician satisfaction, suggesting that different training methods can be effective in various contexts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Statewide Randomized Controlled Trial to Compare Three Models for Implementing Parent Child Interaction Therapy. Herschell, AD., Kolko, DJ., Scudder, AT., et al.[2023]

The Mother-Infant Transaction program (MITP) significantly reduced postpartum depression in mothers of preterm infants one month after discharge and increased breastfeeding duration at 9 months, indicating its efficacy in supporting maternal mental health and breastfeeding practices.

However, the intervention did not show significant improvements in total parenting stress or perceived infant communication skills at 12 months, suggesting that while MITP has benefits, it may not address all aspects of parenting challenges for mothers of preterm infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of early mother-infant intervention on outcomes in mothers and moderately and late preterm infants at age 1 year: a randomized controlled trial. Ravn, IH., Smith, L., Smeby, NA., et al.[2015]

The Therapist-Parent Interaction Coding System (TPICS) effectively captures various coaching techniques used by therapists during Parent-Child Interaction Therapy (PCIT), based on an analysis of 61 video-recorded sessions.

The study found that responsive coaching techniques, such as providing praise, helped improve parents' skills between sessions, while directive coaching methods did not show the same effect, indicating the importance of tailored feedback in enhancing parenting behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the Key to Effective Coaching in Parent-Child Interaction Therapy: The Therapist-Parent Interaction Coding System. Barnett, ML., Niec, LN., Acevedo-Polakovich, ID.[2021]

This study aims to synthesize parental views on parent-child interaction therapy, which is crucial for improving communication skills in children, highlighting the importance of caregiver engagement in the intervention's success.

The research will involve a systematic review of qualitative studies, ensuring a comprehensive understanding of parents' experiences and perceptions, which will inform best practices and policies for implementing this therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stage 1 Registered Report: The experiences and perceptions of parent-child interaction therapy for parents of young children with communication difficulties: A qualitative evidence synthesis protocol. O'Toole, C., Lyons, R., Ó'Doibhlín, D., et al.[2020]

Parent-child interaction therapy, particularly through methods like Theraplay, effectively prevents and addresses children's mental health issues by enhancing parental sensitivity and positive guidance.

Key features that boost the therapy's effectiveness include the simultaneous involvement of both parents, the use of video observation, and fostering a positive collaborative relationship between parents and therapists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Theraplay--interactive therapy between parent and child in juvenile mental problems]. Mäkelä, J., Salo, S.[2011]

A brief home-based adaptation of Parent-child Interaction Therapy (PCIT) significantly improved infant compliance and reduced behavior problems in infants from high-risk families, as observed at a 6-month follow-up.

Mothers who participated in the intervention exhibited more positive and fewer negative interactions with their infants during play, suggesting enhanced parenting behaviors, although there was no significant change in parenting stress levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral Parent Training in Infancy: A Window of Opportunity for High-Risk Families. Bagner, DM., Coxe, S., Hungerford, GM., et al.[2019]

An additional parenting intervention for very preterm born toddlers, consisting of 4-6 home visits, was found to be feasible and well-received by parents, with high satisfaction reported.

The intervention showed positive outcomes, particularly in areas like motor development and parent-child interaction, with effect sizes ranging from small to large across various developmental measures at 24 months corrected age.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a Preventive Parenting Intervention for Very Preterm Children at 18 Months Corrected Age: A Randomized Pilot Trial. Flierman, M., Koldewijn, K., Meijssen, D., et al.[2018]

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