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

NCT ID: NCT07132411

Last Updated: 2025-12-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2029-06-30

Brief Summary

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.

Conditions

Child Language; Language Delay; Developmental Milestones

Keywords

well-child care; primary care practices; home language environment; preventative intervention; language development; language promotion intervention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Talk With Me Baby Clinics

In TWMB clinics, TWMB will be delivered within usual WCC workflows for anticipatory guidance during the clinical encounter. TWMB is delivered by the primary clinician (i.e., pediatrician/family medicine physician; physician assistant; nurse practitioner) and/or a clinician and care team. TWMB targets key evidence-based language promotion strategies that previous research has shown to improve child language outcomes. TWMB training involves didactic and practice-based instruction (CME/CNE) that includes: (a) a brief review of the science behind why language promotion matters; (b) focused instruction (with video examples and modeling) on how to deliver components of TWMB, including the TWMB Checklist and Language Nutrition Prescription; and (c) live practice and role play with the trainer on delivering TWMB across child ages and families.

Group Type: EXPERIMENTAL

Patients in Talk With Me Baby Clinics

Intervention Type: BEHAVIORAL

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

Care-As-Usual Clinics

Providers/care teams will deliver care-as-usual WCC visits for all children. Parent-child participants in Control clinics will receive WCC anticipatory guidance care as usual. No treatment control is in line with the literature on randomized behavioral/educational interventions.

Group Type: ACTIVE_COMPARATOR

Patients in Care-As-Usual Clinics

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

NIH

Sponsor Role: collaborator

University of Kansas Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brenda J Salley, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

Emory University

Atlanta, Georgia, United States

Site Status: NOT_YET_RECRUITING

University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Brenda J Salley, PhD

Role: CONTACT

Phone: 913-945-7944

Email: bsalley@kumc.edu

Facility Contacts

Susan N Brasher, PhD, RN, CPNP, FAAN

Role: primary

Brenda J Salley, PhD

Role: primary

Megan Olalde, MS, RD, CCRP

Role: backup

Other Identifiers

5R01HD112446-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00151172

Identifier Type: -

Identifier Source: org_study_id