Talk With Me Baby to Enhance the Early Home Language Environment

Launched by IDEA STATES PEDIATRIC CLINICAL TRIALS NETWORK · Jun 26, 2024

Keywords

ClinConnect Summary

The "Talk With Me Baby" clinical trial is designed to see if a special program can help families with young children talk more at home. The program is offered to caregivers during routine checkups for their babies, who are between two to six months old. The main goal is to find out if this program encourages caregivers to spend more time talking to their infants, which is important for the child's language development.

To participate in this study, caregivers need to attend at least four well-child checkups at a participating clinic and agree to record their conversations with their baby before and after the program is introduced. Eligible caregivers must be adults who can understand and speak English and should live with their child, spending enough time together each week. The child must be healthy, born on time, and should not have any significant developmental delays. If you're interested in joining, you'll be helping researchers learn how to better support families in enhancing their children’s early language experiences.

Gender

ALL

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.