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

Overview

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.

Detailed description

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.

Interventions

• Behavioral Patients in Talk With Me Baby Clinics
  Parent-child participants in TWMB clinics will attend their regular WCC visits (scheduled per routine clinic processes) following the AAP Periodicity Schedule.
• Behavioral Patients in Care-As-Usual Clinics
  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 outcome measures

• Change in parent language-promotion behavior [Time frame: Child age 1, 6, 12, and 18 months old]
• Child total language [Time frame: Child age 24 months old]
• Child receptive language [Time frame: Child age 24 months old]
• Child expressive language [Time frame: Child age 24 months old]

Secondary outcome measures (9)

• Change in parent language promotion knowledge [Time frame: Child age 1, 12, and 24 months old]
• Change in Child vocalizations and verbalizations [Time frame: Child age 1, 6, 12, and 18 months old]
• Change in child receptive vocabulary [Time frame: Child age 12, 18, and 24 months old]
• Change in child expressive vocabulary [Time frame: Child age 12, 18, and 24 months old]
• Parent contingent responding scores for a subset of the sample [Time frame: Child age 18 months old]
• Parent contingent verbal scaffolding scores for a subset of the sample [Time frame: Child age 18 months old]
• Feasibility of intervention for treatment arm only [Time frame: Upon study completion, approximately 2 years]
• Acceptability of intervention for treatment arm only [Time frame: Upon study completion, approximately 2 years]
• Appropriateness of intervention for treatment arm only [Time frame: Upon study completion, approximately 2 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 2 centers

• Emory University — Atlanta
• University of Kansas Medical Center — Kansas City

Identifiers

NCT: NCT07132411 · STUDY00151172 · 5R01HD112446-02

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗