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

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the treatment Enriched Parent-Infant Interaction?

Research on similar treatments like Parent-Child Interaction Therapy (PCIT) shows positive effects on improving parent and child behaviors, especially when parents receive responsive coaching. Additionally, a home-based adaptation of PCIT for at-risk infants showed significant improvements in parent-infant interactions and infant behavior problems. ^{1 2 3 4 5}

Is Parent-Infant Interaction Therapy safe for humans?

Parent-Infant Interaction Therapy, also known as Parent-Child Interaction Therapy (PCIT), has been widely studied and is considered safe for humans. It is a well-established program used to improve parent-child relationships and reduce children's disruptive behaviors, with no significant safety concerns reported in the research. ^{6 7 8 9 10}

How does the Enriched Parent-Infant Interaction treatment differ from other treatments for parent-infant interaction issues?

The Enriched Parent-Infant Interaction treatment is unique because it focuses on enhancing the quality of interactions between parents and infants, emphasizing warmth, sensitivity, and support for learning and autonomy. Unlike standard care, this treatment involves structured, home-based interventions that have shown to improve infant compliance and reduce behavior problems, particularly in high-risk families. ^{6 11 12 13 14}

Research Team

Samuel Mehr

Principal Investigator

Yale University

Eligibility Criteria

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.

Investigators will recruit parents or primary caregivers who have a smartphone

Exclusion Criteria

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Home-Based Preventive Parenting Intervention for at-Risk Infants and Their Families: An Open Trial. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Feasibility of a Preventive Parenting Intervention for Very Preterm Children at 18 Months Corrected Age: A Randomized Pilot Trial. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

A Community Mental Health Implementation of Parent-Child Interaction Therapy (PCIT). [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Behavioral outcomes of Parent-Child Interaction Therapy and Triple P-Positive Parenting Program: a review and meta-analysis. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Assessing the Key to Effective Coaching in Parent-Child Interaction Therapy: The Therapist-Parent Interaction Coding System. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Behavioral Parent Training in Infancy: A Window of Opportunity for High-Risk Families. [2019]

7. England pubmed.ncbi.nlm.nih.gov

A Statewide Randomized Controlled Trial to Compare Three Models for Implementing Parent Child Interaction Therapy. [2023]

8. Ireland 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. [2020]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Evidence-Based Treatment in Practice: PCIT Research on Addressing Individual Differences and Diversity Through the Lens of 20 Years of Service. [2023]

10. Finland pubmed.ncbi.nlm.nih.gov

[Theraplay--interactive therapy between parent and child in juvenile mental problems]. [2011]

11. United States 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. [2015]

12. United States pubmed.ncbi.nlm.nih.gov

Introduction to the Parent-Child Interaction Assessment. [2004]

13. Ireland pubmed.ncbi.nlm.nih.gov

Influences of a dedicated parental training program on parent-child interaction in preterm infants. [2015]

14. United States pubmed.ncbi.nlm.nih.gov

GETTING READY: RESULTS OF A RANDOMIZED TRIAL OF A RELATIONSHIP-FOCUSED INTERVENTION ON THE PARENT-INFANT RELATIONSHIP IN RURAL EARLY HEAD START. [2021]