Enhancing early language development in infants through caregiver interaction
Talk With Me Baby: Leveraging Well-Child Care to Enhance the Early Home Language Environment for Rural and Underserved Children
This study is testing if a program that helps caregivers talk more with their babies can improve language skills in infants aged two to six months from at-risk families.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 0 Months to 9 Months |
| Sex | All |
| Sponsor | IDeA States Pediatric Clinical Trials Network Research network |
| Locations | 2 sites (Kansas City, Kansas and 1 other locations) |
| Trial ID | NCT06479278 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to determine if the Talk With Me Baby (TWMB) program can improve the home-language environment for at-risk families with infants aged two to six months. Caregivers will receive the TWMB program during routine well-child checkups and will be encouraged to increase their verbal interactions with their infants. Participants will record their conversations with their infants before and after the program to assess changes in caregiver talk time. The study seeks to enhance language development by fostering more engaging communication between caregivers and infants.
Who should consider this trial
Good fit: Ideal candidates include caregiver-infant dyads where the caregiver is of legal age, can communicate in English, and has a baseline language assessment score below the 75th percentile.
Not a fit: Patients who may not benefit include those whose caregivers do not meet the inclusion criteria or who have a baseline language assessment score above the 75th percentile.
Why it matters
Potential benefit: If successful, this program could significantly improve language development outcomes for infants in at-risk families.
How similar studies have performed: Other studies have shown success in enhancing early language development through caregiver interventions, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Kansas City, Kansas and 1 other locations
- Kansas University Medical Center — Kansas City, Kansas, United States (Recruiting)
- West Virginia University — Morgantown, West Virginia, United States (Not_yet_recruiting)
Study contacts
- Study coordinator: Song Ounpraseuth, PhD
- Email: STOunpraseuth@uams.edu
- Phone: 501-686-7233
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.