Recruiting

Talk With Me Baby

Sponsor:

IDeA States Pediatric Clinical Trials Network

Code:

NCT06479278

Conditions

Language Development

Speech

Infant Development

Infant Behavior

Language, Child

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

Interventions

Talk with Me Baby

Study Details

Brief summary:

The goal of this clinical trial is to learn if the Talk With Me Baby (TWMB) program improves the home-language environment for at-risk families with children ages two to six months when primary care providers deliver the program during well-child checkups. The main question it aims to answer is:

Will the TWMB program increase the time a caregiver talks to their infant?

Participants will:

1. Come to at least four well-child checkups
2. Receive the TWMB program from the provider during the checkups
3. Record their conversations with their infant before they receive the program and after they receive the program four times.

Conditions

Language Development

Speech

Infant Development

Infant Behavior

Language, Child

Study ID

NCT06479278

Start date

Feb 3, 2025

Status verified date

Jul, 2025

Completion date

Aug 31, 2026

Anticipated

Primary completion date

Aug 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

Inclusion Criteria:

For this study, each child-caregiver dyad will consist of:

1. A caregiver who will receive TWMB during routine WCC visits for their child at participating clinics, and
2. The child of the above caregiver for whom the WCC visits are conducted.

A potential caregiver participant must meet all the following inclusion criteria to enroll in the study:

1. Be the age of majority, or older, as defined by the state of residency.
2. Able to complete study measures in English.
3. Have the legal authority to consent to participate for themselves and to consent on behalf of their child.

To proceed to the follow-up portion of the study the caregiver (dyad) must have a LENA baseline assessment score that is ≤ 75th percentile compared to a child's age-referenced normative data.

A potential child participant must meet all the following inclusion criteria to be enrolled in the study:

1. Receive WCC at a participating clinic from a participating provider.
2. Be zero to nine months (+ 0-30 days) old at enrollment.
3. Was born at full term (> 37 weeks gestation).
4. Was born in a singleton birth (i.e., was the only child delivered during the birth).

Study Design

Enrollment

66 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Talk With Me Baby

Interventions

Talk with Me Baby

Primary care providers will embed Talk With Me Baby (TWMB) within standard-of-care Well-Child Care visits for children ≤36 months of age. Children will receive usual care plus a brief language-promotion intervention (TWMB) in up to 4 consecutive Well-Child Care visits during their 12-month period.

Primary outcome measure

  • Improvement in the home-language-environment promotion behaviors, as measured by the Language Environment Analysis (LENA) Conversational Turn Count percentile score from Baseline to Post-Intervention [ Time Frame: 12 months ]
  • Improvement in the home-language-environment promotion behaviors, as measured by the Language Environment Analysis (LENA) Adult Word Count percentile score from Baseline to Post-Intervention [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Locations

Kansas University Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

More Information

Sponsor

IDeA States Pediatric Clinical Trials Network

Last update posted

Aug 29, 2025

Last verified

Jul, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by IDeA States Pediatric Clinical Trials Network on 2025-08-29.