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Behavioral Intervention
Talk With Me Baby for Infant Language Development (TWMB Trial)
N/A
Waitlist Available
Research Sponsored by IDeA States Pediatric Clinical Trials Network
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Child must receive WCC at a participating clinic from a participating provider, be two to six months old at enrollment, born at full term (> 37 weeks gestation), and born in a singleton birth
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to see if the Talk With Me Baby program can improve how much caregivers talk to their infants in at-risk families with children aged two to six months. Caregivers will attend four well
Who is the study for?
This trial is for families with children aged 2-6 months who may be at risk of language development issues. Caregivers must commit to attending at least four well-child checkups and recording their conversations with their infant before and after receiving the TWMB program.
What is being tested?
The study tests if the 'Talk With Me Baby' (TWMB) program, given by primary care providers during regular checkups, can increase how much caregivers talk to their infants, potentially enhancing language development in early childhood.
What are the potential side effects?
There are no medical side effects associated with this intervention as it involves educational guidance rather than medication or clinical treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My child is 2-6 months old, born full-term and not part of a multiple birth, and sees a doctor at a participating clinic.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Talk With Me BabyExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
University of KansasOTHER
154 Previous Clinical Trials
331,875 Total Patients Enrolled
IDeA States Pediatric Clinical Trials NetworkLead Sponsor
6 Previous Clinical Trials
1,191 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,832 Previous Clinical Trials
8,170,253 Total Patients Enrolled