Recruiting

Talk With Me Baby

Sponsor:

University of Kansas Medical Center

Code:

NCT07132411

Conditions

Child Language

Language Delay

Developmental Milestones

Eligibility Criteria

Sex: All

Age: 0 - 2

Healthy Volunteers: Not accepted

Interventions

Patients in Talk With Me Baby Clinics

Patients in Care-As-Usual Clinics

Study Details

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

Study ID

NCT07132411

Start date

Feb 5, 2026

Status verified date

Mar, 2026

Completion date

Jun, 2029

Anticipated

Primary completion date

Mar, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 2

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

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.

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 measure

  • 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 ]

Central Contacts and Locations

Central contacts

Brenda J Salley, PhD

913-945-7944bsalley@kumc.edu

Locations

University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Brenda J Salley, PhD

913-945-7944bsalley@kumc.edu

Megan Olalde, MS, RD, CCRP

913-588-2042molalde@kumc.edu

Principal Investigator:

Brenda J Salley, PhD

More Information

Sponsor

University of Kansas Medical Center

Last update posted

Mar 24, 2026

Last verified

Mar, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Kansas Medical Center on 2026-03-24.