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NCT Number: NCT07132411

Talk With Me Baby: Leveraging Well-Child Care to Enhance the Early Home Language Environment

Language-rich interactions with a parent or caregiver can serve as a protective factor for young children, by supporting their language development and other positive long-term outcomes, but existing interventions have not had the necessary reach to families who need this information the most. This study utilizes the primary care setting as a low cost, scalable way to deliver language promotion intervention. Specifically, we will test the effectiveness and explore implementation of language promotion intervention (Talk With Me Baby) that embeds within anticipatory guidance during pediatric well-child care to boost early language development and optimize health, academic, and economic outcomes.

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Key information

Conditions

Child Language Communication Disorders Developmental Milestones Language Delay Language Development Disorders Language Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

1 day–2 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emory University, Atlanta, Georgia, United States

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About this study

The quality of early language interactions with parents and caregivers in early childhood has long-term implications for a child's social, economic, and physical heath. Differences in the home language environment (HLE) are well established and cross all sociodemographic characteristics. Although several decades of research have identified evidence-based strategies that enhance the HLE and improve child outcomes, they have failed to reduce population-level differences in child language development and long-term outcomes. The study utilizes Talk With Me Baby (TWMB) as a novel tool to increase language building interactions between parent/caregiver and child. Because TWMB is delivered in the primary care setting (which reaches up to 98% of families with infants and toddlers), it is scalable, low-cost, and universal. With TWMB, healthcare providers can embed evidence-based language promotion into their well-child care (WCC) anticipatory guidance for all children age 0-3 years. TWMB builds on decades of well-controlled language intervention efficacy trials and has been deployed clinically for 8+ years. This study is a type 1 hybrid effectiveness implementation trial to measure the impact of TWMB on gains in the HLE and subsequent child language outcomes. The trial is both randomized and controlled across 2 sites: a TWMB intervention group (8 clinics) and a care-as-usual control group (8 clinics). In TWMB clinics, providers and care teams will be trained to deliver TWMB during all 2-24 month WCC visits. Across TWMB and control clinics, we will enroll 25 parent-child dyads in each clinic (n=400 total) prior to their 2-month WCC visit and follow them through their 24-month WCC visit.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for Participants:

  • Child must be enrolled prior to attending their 2-month WCC visit, age 1 month (+/- 30 days)
  • Full term (>=37 weeks gestation)
  • Singleton birth
  • Home language of English and/or Spanish
  • Child must receive WCC at a participating clinic

Exclusion criteria

for Participants:

  • Child with a severe congenital disorder that would affect neurodevelopmental outcomes, or hearing impairment that could affect participation
  • Parent does not live with or spend >=2 days/week with the child
  • Family does not plan to continue services at the clinic

Inclusion criteria

for Clinics:

  • A primary care practice (family medicine or pediatric model) that delivers WCC for children from 0-36 months old
  • A minimum of 30% Medicaid/uninsured visits/year
  • A minimum of 300 unique 0 to 36-month-old patients/year

Treatment and study plan

Patients in Talk With Me Baby Clinics

Behavioral

Parent-child participants in TWMB clinics will attend their regular WCC visits (scheduled per routine clinic processes) following the AAP Periodicity Schedule.

Patients in Care-As-Usual Clinics

Behavioral

Parent-child participants in Care-As-Usual clinics will attend their regular WCC visits (scheduled per routine clinic processes) following the AAP Periodicity Schedule. Measures will be completed at five time points.

Primary outcomes

  1. Change in parent language-promotion behavior

    Time frame: Child age 1, 6, 12, and 18 months old

    Change in parent language-promotion behavior (as measured by Language Environment Analysis [LENA] Conversational Turn Count) at each assessment time point (child age 1, 6, 12, and 18 months old) for parent-child dyads in TWMB clinics, compared to care-as-usual clinics.

  2. Child total language

    Time frame: Child age 24 months old

    Child language (as measured by the Preschool Language Scale-5 [PLS-5/PLS-5 Spanish] for Total Language) at child age 24 months old for parent-child dyads in TWMB clinics, compared to care-as-usual clinics.

  3. Child receptive language

    Time frame: Child age 24 months old

    Child receptive language (as measured by the Preschool Language Scale-5 [PLS-5/PLS-5 Spanish] for Receptive Language) at child age 24 months old for parent-child dyads in TWMB clinics, compared to care-as-usual clinics.

  4. Child expressive language

    Time frame: Child age 24 months old

    Child expressive language (as measured by the Preschool Language Scale-5 [PLS-5/PLS-5 Spanish] for Expressive Language) at child age 24 months old for parent-child dyads in TWMB clinics, compared to care-as-usual clinics.

Secondary outcomes

  1. Change in parent language promotion knowledge

    Time frame: Child age 1, 12, and 24 months old

    Parent language promotion knowledge (as measured using the Survey of Parent Expectations & Knowledge [SPEAK] total score) at each child age 1, 12, and 24 months old for parent-child dyads in TWMB clinics, compared to care-as-usual clinics.

  2. Change in Child vocalizations and verbalizations

    Time frame: Child age 1, 6, 12, and 18 months old

    Change in child vocalizations and verbalizations (as measured by Language Environment Analysis [LENA] Child Vocalization Count percentile scores) at child age 1, 6, 12, and 18 months old for children in TWMB clinics, compared to care-as-usual clinics.

  3. Change in child receptive vocabulary

    Time frame: Child age 12, 18, and 24 months old

    Change in child receptive vocabulary (as measured by MacArthur-Bates Communicative Development Inventories [MBCDI] Short Form and Spanish Inventario Short Form I/II) at child age 12, 18, and 24 months for children in TWMB clinics, compared to care-as-usual clinics.

  4. Change in child expressive vocabulary

    Time frame: Child age 12, 18, and 24 months old

    Change in child expressive vocabulary (as measured by MacArthur-Bates Communicative Development Inventories [MBCDI] Short Form and Spanish Inventario Short Form I/II) at child age 12, 18, and 24 months for children in TWMB clinics, compared to care-as-usual clinics.

  5. Parent contingent responding scores for a subset of the sample

    Time frame: Child age 18 months old

    Parent contingent responding scores (as measured by behavioral coding of home video recordings during daily routines) at child age 18 months for children in TWMB clinics, compared to care-as-usual clinics.

  6. Parent contingent verbal scaffolding scores for a subset of the sample

    Time frame: Child age 18 months old

    Parent verbal scaffolding scores (as measured by behavioral coding of home video recordings during daily routines) at child age 18 months for children in TWMB clinics, compared to care-as-usual clinics.

  7. Feasibility of intervention for treatment arm only

    Time frame: Upon study completion, approximately 2 years

    Feasibility of intervention (as assessed by the Feasibility of Intervention Measure [FIM]at post-intervention. The study team also plans to conduct interviews with the clinics with the highest and lowest FIM scores to identify facilitators and barriers to implementation.

  8. Acceptability of intervention for treatment arm only

    Time frame: Upon study completion, approximately 2 years

    Acceptability of intervention (as assessed by the Acceptability of Intervention Measure [AIM]) at post-intervention. The study team also plans to conduct interviews with the clinics with the highest and lowest AIM scores to identify facilitators and barriers to implementation.

  9. Appropriateness of intervention for treatment arm only

    Time frame: Upon study completion, approximately 2 years

    Appropriateness of intervention (as assessed by the Intervention Appropriateness Measure [IAM]) at post-intervention. The study team also plans to conduct interviews with the clinics with the highest and lowest IAM scores to identify facilitators and barriers to implementation.

Other outcomes

  1. Moderator: Family strengths and parent resources

    Time frame: Child age 1 month old

    Family strengths and parent resources (as measured using the Healthy Families Parenting Inventory (HFPI) total score) at baseline.

  2. Mediator: Parent language promotion knowledge

    Time frame: Child age 1 month old

    Parent language promotion knowledge (as measured using the Survey of Parent Expectations & Knowledge [SPEAK] total score) at baseline.

  3. Mediator: Home language environment for child outcomes

    Time frame: Child age 1, 6, 12, and 18 months old

    Home language environment (HLE) as measured using Conversational Turns [CT percentile score] at each child age 1, 6, 12, and 18 months old.

  4. Mediator: Dosage of parent input for child outcomes

    Time frame: Child age 1, 6, 12, and 18 months old

    Dosage of parent language input as measured using LENA Adult Word Count [AWC percentile score] at each child age 1, 6, 12, and 18 months old.

Study contacts

Contact information is provided by the study sponsor or research team.

Brenda J Salley, PhD

CONTACT

[email protected]

913-945-7944

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Collaborators

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

Registry information

Acronym: TWMB

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Aug 20, 2025
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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