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

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
University of Kansas Medical Center
Study ID
NCT07132411
Status
Recruiting

Conditions

  • Child Language
  • Developmental Milestones
  • Language Delay

Eligibility Criteria

Sex
ALL
Age
1 Day - 2 Years
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Feb 5, 2026
Status verified
Mar 2026
Primary completion
Mar 31, 2029
Completion
Jun 30, 2029

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Active Comparator: 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.

Primary Outcome Measure

Change in parent language-promotion behavior [ Time Frame: Child age 1, 6, 12, and 18 months old ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Emory UniversityAtlantaGeorgia30322
Susan N Brasher, PhD, RN, CPNP, FAAN
404-727-6490
Susan N Brasher, PhD, RN, CPNP, FAAN (PRINCIPAL_INVESTIGATOR)
University of Kansas Medical CenterKansas CityKansas66160
Brenda J Salley, PhD
913-945-7944
Megan Olalde, MS, RD, CCRP
913-588-2042
Brenda J Salley, PhD (PRINCIPAL_INVESTIGATOR)

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