Talk With Me Baby to Enhance the Early Home Language Environment
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-9
SponsorIDeA States Pediatric Clinical Trials Network
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
A caregiver who will receive TWMB during routine WCC visits for their child at participating clinics, and
The child of the above caregiver for whom the WCC visits are conducted.
Be the age of majority, or older, as defined by the state of residency.
Able to complete study measures in English.
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
Talk with Me Baby
BehavioralPrimary 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.
Treatment groups
66 Participants
are divided into 1 treatment groupGroup A: Talk With Me BabyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
12 months2
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
Time frame
12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
IDeA States Pediatric Clinical Trials Network
Lead sponsor
National Institutes of Health (NIH)
Collaborator
University of Kansas
Collaborator
Source ClinicalTrials.gov