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

NCT07132411 | Recruiting DMC

• 2 other identifiers: STUDY001511725R01HD112446-02
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 2

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.

Conditions

Child Language; Language Delay; Developmental Milestones

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Change in parent language-promotion behavior

  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.

  Child age 1, 6, 12, and 18 months old

• Child total language

  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.

  Child age 24 months old

• Child receptive language

  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.

  Child age 24 months old

• Child expressive language

  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.

  Child age 24 months old

Secondary Outcomes (9)

• Change in parent language promotion knowledge

  Child age 1, 12, and 24 months old

• Change in Child vocalizations and verbalizations

  Child age 1, 6, 12, and 18 months old

• Change in child receptive vocabulary

  Child age 12, 18, and 24 months old

• Change in child expressive vocabulary

  Child age 12, 18, and 24 months old

• Parent contingent responding scores for a subset of the sample

  Child age 18 months old

Other Outcomes (4)

• Moderator: Family strengths and parent resources

  Child age 1 month old

• Mediator: Parent language promotion knowledge

  Child age 1 month old

• Mediator: Home language environment for child outcomes

  Child age 1, 6, 12, and 18 months old

Study Arms (2)

Talk With Me Baby Clinics

EXPERIMENTAL

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.

Behavioral: Patients in Talk With Me Baby Clinics

Care-As-Usual Clinics

ACTIVE COMPARATOR

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.

Behavioral: Patients in Care-As-Usual Clinics

Interventions

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.

Talk With Me Baby Clinics

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.

Care-As-Usual Clinics

Eligibility Criteria

• Age: 1 Day - 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (2)

Emory University

Atlanta, Georgia, 30322, United States

NOT YET RECRUITING

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

RECRUITING

MeSH Terms

Conditions

Language Development Disorders

Condition Hierarchy (Ancestors)

Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Brenda J Salley, PhD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brenda J Salley, PhD

CONTACT

913-945-7944; bsalley@kumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A pragmatic type 1 hybrid effectiveness-implementation cluster randomized controlled trial

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: August 20, 2025
• Study Start: February 5, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

US (2)