Infant Behavior, Infant Development, Language, Language, Child, Language Development, Speech
Conditions
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.
Interventions
BEHAVIORALTalk 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.
Sponsors
National Institutes of Health (NIH)
University of Kansas
IDeA States Pediatric Clinical Trials Network
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
0 Months to 9 Months
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | 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 | 12 months |
Countries
United States
Contacts
Primary ContactSong Ounpraseuth, PhD
Backup ContactDeAnn E Hubberd, MA
Outcome results
None listed