Clinical trial NCT06479278: Talk With Me Baby to Enhance the Early Home Language Environment
Official title: Talk With Me Baby: Leveraging Well-Child Care to Enhance the Early Home Language Environment for Rural and Underserved Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Language Development
Speech
Infant Development
Infant Behavior
Language, Child
Language
Lead sponsor: IDeA States Pediatric Clinical Trials Network
Sponsor class: NETWORK
Collaborators: name: National Institutes of Health (NIH)
name: University of Kansas
First posted: 2024-06-28
Enrollment: 66
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

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

1. A caregiver who will receive TWMB during routine well-childcare checkups (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 two to six 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).

Exclusion Criteria:

A potential caregiver participant must not meet any of the following exclusion criteria to enroll in the study:

1. Has a cognitive impairment or a visual or hearing impairment known to the clinic that limits their ability to make decisions about participating or engaging with the assessments, based on the site primary investigator's (PI's) assessment and local human subjects' research policies.
2. Does not live with child or spend at least two full days (i.e., at least 48 hours) per week with the child.
3. Does not plan for the child to continue receiving services at the participating clinic for at least 12 months.

A potential child participant must not meet any of the following exclusion criteria to enroll in the study:

1. Significant developmental delay or cognitive, visual, or hearing impairment known to the clinic.
2. Previously attended WCC visit prior to enrollment that occurred during the TWMB trial.

Primary outcomes:
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
timeFrame: 12 months
measure: 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
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Kansas University Medical Center
state: Kansas
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
References: