Talk With Me Baby to Enhance the Early Home Language Environment
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
- Language Development
- Speech
- Infant Development
- Infant Behavior
- Language, Child
- Language
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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Talk With Me Baby |
|
Recruiting Locations
Kansas City 4273837, Kansas 4273857 66160
More Details
- Status
- Recruiting
- Sponsor
- IDeA States Pediatric Clinical Trials Network