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Purpose

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

Eligibility

Eligible Ages
Between 0 Months and 9 Months
Eligible Sex
All
Accepts Healthy Volunteers
Yes

Criteria

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

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Prevention
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Talk With Me Baby
  • Behavioral: 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.

Recruiting Locations

Kansas University Medical Center
Kansas City 4273837, Kansas 4273857 66160
Contact:
Brenda Salley, PhD
913-945-7944
bsalley@kumc.edu

More Details

Status
Recruiting
Sponsor
IDeA States Pediatric Clinical Trials Network

Study Contact

Song Ounpraseuth, PhD
501-686-7233
STOunpraseuth@uams.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.