Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U24OD024957 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| University of Kansas | OTHER |
Not provided
Not provided
Not provided
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Talk With Me Baby | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Talk with Me Baby | Behavioral | 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. |
| Measure | Description | 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 |
Not provided
Not provided
Inclusion Criteria:
For this study, each child-caregiver dyad will consist of:
A potential caregiver participant must meet all the following inclusion criteria to enroll in the study:
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:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Song Ounpraseuth, PhD | Contact | 501-686-7233 | STOunpraseuth@uams.edu | |
| DeAnn E Hubberd, MA | Contact | 501-686-5547 | dehubberd@uams.edu |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kansas University Medical Center | Recruiting | Kansas City | Kansas | 66160 | United States |
Investigators will conduct this trial following the publication and data-sharing policies and regulations listed below:
NIH Public Access Policy requires scientists to submit final peer-reviewed journal manuscripts arising from NIH funds to the digital archive PubMed Central upon acceptance for publication.
Environmental Influences on Child Health Outcomes (ECHO) IDeA States Pediatric Clinical Trials Network (ISPCTN) Publications and Presentations Policy ensures the accurate, responsible, and efficient communication of findings from ECHO ISPCTN clinical trials.
NIH Data Sharing Policy and the policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Resulting Information Submission Rule. Other researchers may request data from this trial by contacting Song Ounpraseuth, Ph.D., at the ISPCTN Data Coordinating and Operations Center (DCOC).
Per data sharing polices of NIH and the ISPCTN
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013060 | Speech |
| D018730 | Infant Behavior |
| D007802 | Language |
| ID | Term |
|---|---|
| D014705 | Verbal Behavior |
| D003142 | Communication |
| D001519 | Behavior |
| D002652 | Child Behavior |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| West Virginia University | Not yet recruiting | Morgantown | West Virginia | 26506 | United States |
|