Talk With Me Baby to Enhance the Early Home Language Environment
IDeA States Pediatric Clinical Trials Network · with National Institutes of Health (NIH), University of Kansas · NCT06479278
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 0 mo–10 mo · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Not applicable
- Target enrollment
- 66
- US sites recruiting
- 1
- Study start
- February 3, 2025
- Record last updated
- August 29, 2025
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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
- Come to at least four well-child checkups
- Receive the TWMB program from the provider during the checkups
- Record their conversations with their infant before they receive the program and after they receive the program four times.
Being studied: Talk with Me Baby
Conditions: Language Development; Speech; Infant Development; Infant Behavior; Language, Child; Language
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
For this study, each child-caregiver dyad will consist of:
- A caregiver who will receive TWMB during routine WCC visits for their child at participating clinics, and
- 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:
- Be the age of majority, or older, as defined by the state of residency.
- Able to complete study measures in English.
- 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:
- Receive WCC at a participating clinic from a participating provider.
- Be zero to nine months (+ 0-30 days) old at enrollment.
- Was born at full term (> 37 weeks gestation).
- Was born in a singleton birth (i.e., was the only child delivered during the birth).
Recruiting US locations
Kansas University Medical Center
Kansas City, KS 66160
Site contact: Brenda Salley, PhD · 913-945-7944 · bsalley@kumc.edu
Study contacts (from the official record)
- Song Ounpraseuth, PhD · 501-686-7233 · STOunpraseuth@uams.edu
- DeAnn E Hubberd, MA · 501-686-5547 · dehubberd@uams.edu
Similar studies in Kansas
All healthy volunteers studies in Kansas →- RecruitingHealthy volunteersPhase 1Overnight stay mentioned
Safety and PK of Ceftibuten-ledaborbactam Etzadroxil Fixed-dose Combination
Basilea Pharmaceutica
- Location
- Lenexa, KS
- Eligibility basics
- Ages 18–55
- RecruitingHealthy volunteersPhase 1/Phase 2
A Study of BLB-201 RSV Vaccine in Infants and Children
Blue Lake Biotechnology Inc.
- Location
- Newton, KS + 13 other US sites
- Eligibility basics
- Ages 6 mo–5
- RecruitingHealthy volunteersPhase 1
Evaluation of VX-581 in Healthy Participants and in Participants With Cystic Fibrosis
Vertex Pharmaceuticals Incorporated
- Location
- Overland Park, KS
- Eligibility basics
- Ages 18–55
- RecruitingHealthy volunteersPhase 1
A Study of RO7890597 in Healthy Adult Volunteers
Genentech, Inc.
- Location
- Lenexa, KS
- Eligibility basics
- Ages 18–65